MIKE TYSON has been doing the rounds to physically prepare for his sensational boxing comeback aged 54.

Tyson, who retired in 2005, has a whole new diet and cardio regime as well as going through a "weird" stem cell treatment.

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The former heavyweight king announced plans to make a return to the ring to compete in exhibition bouts for charity, and has been training hard ahead of his comeback.

He is set to face fellow legend Roy Jones Jr on November 28.

Speaking to rapper LL Cool J on the Rock the Bells Radio show on SiriusXM, Tyson explained the methods he is using to get back into fighting shape, as he revealed: "Really I would just change my diet and just do cardio work.

"Cardio has to start, you have to have your endurance to go and do the process of training.

"So something to do is get in cardio, I would try and get two hours of cardio a day, make sure you get that stuff in. Youre gonna make sure youre eating the right food.

"For me its almost like slave food. Doing what you hate to do but doing it like its nothing. Getting up when you dont want to get up.

"Thats what it is. Its becoming a slave to life.

"Being a slave to life means being the best person you can be, being the best you can possibly be, and when you are at the best you can possibly be is when you no longer exist and nobody talks about you. Thats when youre at your best."

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WHAT IS STEM CELL TREATMENT USED FOR?

Stem cell transplants are carried out when bone marrow is damaged or isnt able to produce healthy blood cells.

It can also be used to replace damaged blood cells as the result of intensive cancer treatment.

Here are conditions that stem cell transplants can be used to treat:

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Tyson's return to training for the first time in 15 years has been aided by stem-cell research therapy, that has left him feeling like a "different person".

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition that usually takes the form of a bone marrow transplantation.

Tyson was asked whether that meant if his white blood had been spun and then put back in, to which he replied: "Yes. As they took the blood it was red and when it came back it was almost transfluid (sic).

"I could almost see through the blood, and then they injected it in me.

"And Ive been weird ever since, Ive got to get balanced now."

Having previously claimed he feels in the best shape of his life, Tyson revealed he will be ready and raring to fight again.

He said: "My mind would belong to somebody that disliked me enough to break my soul, and I would give them my mind for that period of time.

"Six weeks of this and Id be in the best shape Ive ever dreamed of being in. As a matter of fact, Im going through that process right now. And you know what else I did, I did stem-cell research."

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During his reign as champion, Tyson would wake up at 4.30am to run before later heading to the gym where he would do 10-12 rounds of boxing mixed in with an array of muscles exercises.

His diet consisted of 3000-4000 calories of carbohydrates and proteins which helped fuel his training sessions.

Tyson, still the youngest heavyweight champion of all time at 20, retired with a record of 50-6-2 and remains one of the most celebrated punchers of all time.

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How Mike Tyson is in such incredible shape at 54 thanks to new diet, cardio and weird stem cell tre - The Irish Sun

Bone Marrow Stem Cells Comments Off on How Mike Tyson is in such incredible shape at 54 thanks to new diet, cardio and weird stem cell tre – The Irish Sun | September 4th, 2020

The independent Data Safety Monitoring Board has completed its first interim analysis of data from a Phase 3 clinical trial evaluating Mesoblast Limited's (MESO -0.3%) remestemcel-L, an allogeneic mesenchymal stem cell product derived from bone marrow, in COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).

Based on preliminary results from 30% of targeted enrollment, the Board recommends that the study continue unchanged.

A total of three interim analyses for stopping accrual early for efficacy or futility will be done (30%, 45% and 60% of total target of randomized patients). Enrollment should be completed in Q4.

The primary endpoint is all-cause mortality within 30 days of randomization. A key secondary endpoint is days alive off mechanical ventilation within 60 days of randomization.

According to the company, remestemcel-L is believed to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

SA Contributor Avisol Capital Partners is Bullish on the stock.

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Late-stage study of Mesoblast cell therapy in COVID-19 to continue as is - Seeking Alpha

Bone Marrow Stem Cells Comments Off on Late-stage study of Mesoblast cell therapy in COVID-19 to continue as is – Seeking Alpha | September 4th, 2020

Compiled by Gabi Zietsman | Health24

04 Sep 2020, 02:45

Two hikers are going to great heights to increase awareness of blood disorders, and the urgent need for bone marrow donors in South Africa.

In a symbolic hike up the country's highest peak in the Drakensberg range, adventurer and bone marrow donor Clayton Coetzee and expert mountaineer and author Gavin Raubenheimer will be tackling Mafadi from 7 to 9 September in honour of those who have helped save the lives of countless people suffering from blood disorders.

Bone marrow donation is close to my heart as one of my dearest friends got sick with Acute Myeloid Leukaemia (AML) several years ago," says Coetzee. "Its then when I heard about the SA Bone Marrow Registry and the life-saving work that they do, and I decided to sign up as a donor."

READ | Could smoking lead to this blood disorder?

Increase in cases

Blood cancer is one of the most common of these disorders and affects children the most, while other blood disorders include non-Hodgkin lymphoma (NHL).

Unfortunately, according to the Search Coordinator for the SA Bone Marrow Registry (SABMR) Alicia Venter, these diseases have increased in the last decade 45% in NHL cases and 26% in leukaemia cases.

"While recommended, prevention efforts, such as lifestyle changes, tend to be less effective for hematologic malignancies than for other cancers, which makes a blood stem cell transplant a patients only hope for survival," says Venter.

In order to be a suitable bone marrow donor, your human leukocyte antigen (HLA) needs to match someone in need. HLAs are genes in a human's DNA that help regulate immunity and affect whether or not a recipient's body will reject a transplant.

READ MORE | Bone marrow transplants less risky now

Need more non-white donors

Finding a match, however, isn't as easy as swiping on a dating app and SAMBR has a serious lack of diversity in the donor database. Currently, there are only about 74 000 local donors on the South African Bone Marrow Registry.

In South Africa, there is a dire need for donors of colour," explains Venter.

"When it comes to matching HLA types, a patients ethnicity plays an important role as HLA markers are inherited. Some ethnic groups have more complex tissue types than others, therefore finding a match is most likely to come from someone of the same ethnic group."

'As easy as giving blood'

The hike is supposed to be symbolic of the uphill battle that faces those suffering from blood disorders, including finding a suitable donor to increase their chances of survival. Besides the gruelling experience, SAMBR will also be doing a cheek swab drive at the same time in Agulhas, Western Cape, and Musina, Limpopo, to help boost donor registrations.

According to Coetzee, it's easy to be registered as a donor all it takes is a cheek swab. If you do match with someone, it's "almost as easy as giving blood".

If a match is found, a donor will undergo a full medical exam to look for any exclusionary factors like obesity, HIV status, other chronic conditions and viral infections. Once cleared, the donor goes on a five-day treatment of injections to increase the number of stem cells in the bloodstream.

On the fifth day, the donor will be admitted to a hospital and connect to a cell separator machine, where the bone marrow donation would be made. The collected samples then has 72 hours to be transplanted to the receiving patient.

In South Africa, doctors will seldom collect bone marrow straight from the source.Possible side effects to receiving the injections may include headache, bone pain and flu-like symptoms.

I want people to know that blood diseases can affect anyone, regardless of ethnicity or gender. Extending beyond our boundaries or comfort zones like climbing Mafadi can be hard, but imagine the indelible difference the act of becoming a donor can have on someone elses life and their loved ones, says Coetzee.

You can follow the hikers' journey onSAMBR's Facebook page.

If you are between the ages of 18 and 45 and want to become a donor, contact the SABMR on021 447 8638 oremail:donors@sabmr.co.za.For more info and how to donate, visit their website.

READ MORE | Leukaemia survivor stories

Image credit: Pixabay

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There is a dire need for 'donors of colour' in the fight against blood disorders - Health24

Bone Marrow Stem Cells Comments Off on There is a dire need for ‘donors of colour’ in the fight against blood disorders – Health24 | September 4th, 2020

Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that it will host a two-part virtual miniseries in September focused on key topics related to omidubicel, an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of a bone marrow transplant. The webcasts will take place on Friday, September 11, 2020, and Wednesday, September 23, 2020, both at 1:00 p.m. ET.

The miniseries topics are as follows:

In May, Gamida Cell reported that its Phase 3 study of omidubicel met its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. Gamida Cell expects to present the full data set, including secondary endpoint data, at a medical meeting in the fourth quarter of 2020. The company also expects to begin submitting the biologics license application for omidubicel to the U.S. Food and Drug Administration (FDA) on a rolling basis in the fourth quarter of 2020. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the U.S. and EU.

Each webcast will be available on the Investors & Media section of the Gamida Cell website at http://www.gamida-cell.com. A replay of the webcast will be available about two hours after the event, for approximately 90 days.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230 and NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.1,2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit http://www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the anticipated timing of data disclosures and regulatory filing submissions, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the ongoing global COVID-19 pandemic and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on February 26, 2020, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

References

1Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al. Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374. 2Gamida Cell press release, Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies, issued May 12, 2020. Last accessed August 31, 2020.

Investor Contact:Jaren Irene Madden

[emailprotected]1-617-286-6264

Media Inquiries:Matthew Corcoran

[emailprotected]1-617-866-7350

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Gamida Cell Announces Two-Part Virtual Miniseries Focused on Omidubicel to Take Place in September - Global Banking And Finance Review

Bone Marrow Stem Cells Comments Off on Gamida Cell Announces Two-Part Virtual Miniseries Focused on Omidubicel to Take Place in September – Global Banking And Finance Review | September 4th, 2020

Global Coronavirus pandemic has impacted all industries across the globe, Progenitor Cell Product market being no exception. As Global economy heads towards major recession post 2009 crisis, Cognitive Market Research has published a recent study which meticulously studies impact of this crisis on Global Progenitor Cell Product market and suggests possible measures to curtail them. This press release is a snapshot of research study and further information can be gathered by accessing complete report. To Contact Research Advisor Mail us @ [emailprotected] or call us on +1-312-376-8303.

Report is a detailed study of the Progenitor Cell Product market, which covers all the essential information required by a new market entrant as well as the existing players to gain a deeper understanding of the market. Report has been segmented into Geographical Segmentation, Key players, Key Topics Industry Value and Demand Analysis Forecast to 2027 and provides comprehensive investigation.

Global Progenitor Cell Product Market: Product analysis: Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

Global Progenitor Cell Product Market: Application analysis: Medical care, Hospital, Laboratory

Major Market Players with an in-depth analysis: NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

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The report gives detailed account on each segment which helps to understand market more effectively. The company profiling of key players include: business overview, product description, research and development investment, key development, business strategy, and SWOT analysis. It also involves sales revenue of each division and geographical coverage for two consecutive years.

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About Us:Cognitive Market Research is one of the finest and most efficient Market Research and Consulting firm. The company strives to provide research studies which include syndicate research, customized research, round the clock assistance service, monthly subscription services, and consulting services to our clients. We focus on making sure that based on our reports, our clients are enabled to make most vital business decisions in easiest and yet effective way. Hence, we are committed to delivering them outcomes from market intelligence studies which are based on relevant and fact-based research across the global market.Contact Us: +1-312-376-8303Email: [emailprotected]Web: https://www.cognitivemarketresearch.com/

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Global and Asia Pacific Progenitor Cell Product Market to Witness Huge Growth by 2027 Major Manufacturers included in report NeuroNova AB, StemCells,...

Cardiac Stem Cells Comments Off on Global and Asia Pacific Progenitor Cell Product Market to Witness Huge Growth by 2027 Major Manufacturers included in report NeuroNova AB, StemCells,… | September 4th, 2020

Featured image: A human baby, just days after its birth, with the umbilical cord stump still attached. Photo: Wikimedia Commons/Evan-Amos, Public Domain

My patient, a man in his 70s, sat a few feet away from me in a clinic room at our cancer centre. His wife was by his side, both literally and emotionally she was his touchstone, his connection to the normal life he led before his leukemia diagnosis. I noticed they tended to wear outfits that even complemented each other, as if their sartorial choices had harmonized and become intertwined along with their affection over the 40 years of their marriage. Their choice for the day: grey sweatshirts declaring their allegiance to the hapless Cleveland Browns.

He had weathered the slings and arrows of the chemotherapy we used to treat his cancer during a five-week hospital stay, and now was in a tenuous remission. We talked about the next steps in his treatment, which ranged from giving him a break, to more chemotherapy, to considering the most aggressive intervention we could offer a bone marrow transplant.

The phrase bone marrow transplant was a bit of a misnomer, though. While we could wipe out any residual leukemia in his bone marrow with high-dose chemotherapy and replace his fresh bone marrow from a healthy person, we may not be able to find a good bone marrow match. Another potential option: We could use umbilical cord blood from a newborn, which is rich in the stem cells normally found in the bone marrow, and which recent studies have shown may not need to match as closely as is necessary for a marrow donor. Hearing this, my patients wife interjected.

Our daughter is pregnant, and her due date is next month. She started, glancing at my patient as he nodded his head in agreement. She wanted us to ask if she should save the babys cord blood in case he needs it for a transplant.

I explained to them that the babys cord blood was unlikely to be a close enough match to my patient, as my patients daughter would only be a half-match for him, and her baby less than that. My patient then asked me a question I have been hearing more and more over the years: Should my daughter save the cord blood in case our grandbaby needs it, in case he or she develops cancer?

Indeed, in the US, the practice of storing umbilical cord blood is steadily on the rise. Banking cord blood in case a bone marrow transplant is needed in the future is appealing on so many levels. The umbilical cord attaching the developing fetus to its mothers placenta is rich in those juicy bone marrow stem cells that are so effective at making the blood components. Coming from an infant at the time of birth, they should be uncorrupted by cancer (emphasis on theshould, as well see in a moment). Cord blood is also easy to collect: At the time of delivery, after the cord is cut, the remaining blood in that cord is milked out into a collection bag. That bag is then kept in a freezer until the time comes, if ever, when it is needed and can be infused as a transplant.

The cost of using commercial cord blood banking companies, however, can be substantial. Upfront charges with whats called an enrollment fee can range from $1,500 to $3,500. On top of that, a yearly storage fee is assessed, with the total amount for 18-20 years of storage cresting $5,000 in some cases.

Brochures for these companies line Plexiglas display cases in obstetrics offices, with pamphlets exhorting nervous, expectant parents to protect their baby from the medical evils that lie ahead. What better source for a transplant than a childs own, pure stem cells, harvested at a time years before that child ever developed cancer? But cost aside, is the effort even worth it for the risk that a child may one day develop a cancer and need a future transplant?

Taking a couple of things into consideration

To answer this question, we need to take a couple of things into consideration. First, what is the likelihood of a child developing a cancer, and then needing a transplant to treat that cancer? Astudy conducted by the Center for International Blood and Marrow Transplant Research attempted to figure this out. They first identified the cancers for which transplantation could potentially be needed. For people aged 0-19 years (the length of time a cord blood would be kept banked) leukemia was the most common, followed by lymphoma, neuroblastoma, brain tumors, and sarcomas. Cancer in children and adolescents are rare all told, the incidence rate in the US for all of these cancers combined is about 12 per 100,000 children per year. Its horrible if its your child who develops cancer, but pediatric cancer is still an uncommon event.

The next conclusion is based on the likelihood that these cancers would not be eradicated by chemotherapy and/or radiation therapy and would require an allogeneic transplant that is, one that uses stem cells taken from a genetically matched donor and the assumption that everyone could identify a sibling or brother from another mother transplant and was healthy enough to undergo the procedure. The authors estimated that the incidence rate of transplant for children and adolescents was a little over 2 per 100,000 per year in the US during their first two decades of life. Analyzed another way, the probability a child will need a transplant by the time he or she reaches age 20 is 0.04%.

The lifetime chance of getting struck by lightning is similar, at about 1 in 3,000, or 0.033%.

Would you pay thousands of dollars for a medication right now, in the event that sometime in your life you may be struck by lightning, and that medication may help you survive the lightning strike?

Seems excessive to me.

Also Read: Crosstalk: How Two Modest Heroes Won the Battle Against Childhood Leukaemia

Is cord blood really as pure as we think?

A second way of determining the value of cord blood banking in case a child develops cancer is to consider whether that cord blood is really as pure as we think. The most common childhood cancer through age 19 is leukemia, with an annual incidence rate of 4.7 per 100,000 children in the US. Could it be possible that the leukemia was present at some small level even at birth, years before the child was diagnosed with leukemia?

One approach to studying this would be to screen every newborn for leukemia. Given the incidence rate of childhood leukemia, this would mean subjecting over 21,000 babies to a blood test for every case of future leukemia identified.

Its difficult to justify that type of monumental screening effort to answer a research question about the origins of leukemia. A more reasonable approach would be to identify children who have leukemia, and try to determine whether they had it when they were born.

But how to go about obtaining a blood sample from a birth that occurred years earlier? A group of clever scientists from the UK and Germany thought the answer might be found in something called Guthrie cards. Robert Guthrie was a microbiologist working at the Roswell Park Cancer Institute in Buffalo, New York, in the 1950s when his niece was diagnosed with phenylketonuria (PKU), an inherited deficiency in the enzyme necessary to metabolize the amino acid phenylalanine. If caught early enough, an infants diet can be modified so that the effects of the deficiency are minimised. If not, the condition can lead to developmental defects and mental disability.

Guthries niece was not so lucky.

This, and having a child of his own with cognitive delays, motivated Guthrie to devote his career to detecting preventable childhood diseases. He developed a test for PKU that could be performed when a drop of blood from a finger prick or heel stick was applied to filter paper on a card. It was successfully piloted in Newark in 1960, and by 1963, 400,000 infants had been tested in 29 states. Testing spread around the country, and across the pond.

And hospital laboratories kept those Guthrie cards for years after a child was born.

A startling discovery

The scientistsfound three children with acute lymphocytic leukemia (more common in children than AML, whereas the opposite is true in adults) who had the same chromosome mutation associated with their leukemias a translocation of chromosomes 4 and 11. After obtaining permission from the parents of these children, the scientists then searched laboratory repositories to find the Guthrie cards stored there from when the children were born.

They used a PCR-specific lab test for this translocation on the dried blood still remaining on the childrens Guthrie cards, and were able to detect the chromosome abnormality for all three children from a blood drop obtained months or years before the leukemia was diagnosed. In another, similar study, the same group of scientists was able to detect chromosome evidence of leukemia in 9 of the 12 Guthrie cards obtained from children who diagnosed with leukemia between two and five years later.

The leukemia was there all along, even prior to birth in these children, waiting years in some cases to rear its ugly head. And if the leukemia was measurable on a genetic level in their blood, it was almost certainly present in their cord blood. Banking cord blood from these children would have preserved those juicy, healthy stem cells, but also probably cells already corrupted by genetic abnormalities that would lead to leukemia again, if the cells were re-infused into a child as a transplant years later.

Getting back to the question: Is the cost and effort of banking cord blood worth it for the risk that a child may one day develop a cancer and need a future transplant?

I didnt think so when my three children were born.

But I did have their cord blood collected and I donated it to be stored for use through theBe The Match programme, in case a complete stranger needs it. So that one day, my children could be the brothers from another mother, or sister from another mister me being the mister!

And so that one day, my patients wont have to forego potentially curative treatments for their leukemias because they cant find an adequate donor.

Mikkael Sekeres is the director of the Leukemia Program at the Cleveland Clinic and the author of When Blood Breaks Down: Life Lessons from Leukemia, from which this article is adapted.

This article was originally published on The MIT Press Reader.

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The Fallacy of Banking Umbilical Cord Blood for Your Baby - The Wire Science

Bone Marrow Stem Cells Comments Off on The Fallacy of Banking Umbilical Cord Blood for Your Baby – The Wire Science | September 3rd, 2020

A young girl with an extremely rare blood disorder has been dealt a huge blow after her bone marrow donor her only match in the world pulled out at the last moment.

After developing a pinprick rash on her back, eight-year-old Evie Hodgson from Yorkshire in the UK was diagnosed with deadly aplastic anaemia in May, a blood disease in which the body doesnt produce enough blood cells.

The schoolgirl was due to undergo a bone-marrow transplant this month that would save her life but her donor called as she was preparing for the operation.

Evies parents Andy and Tina, and younger brother William, were sadly not a match, but they did find a 10/10 match, with the anonymous donor agreeing to the transplant.

But as she prepared for the transplant by having one of her ovaries removed and undergoing dental work, on August 14, just days before the planned surgery, the donor pulled out.

RELATED: Mum stranded in Ukraine after surrogate gives birth

Now her parents have set up a Facebook page to help find a new hero, calling on people to get tested and see if they are a match.

Initially it seemed that Evie had been lucky as a match for the transplant was found quickly and the procedure was planned to take place in August, a post on the Evie Needs a Hero Facebook page reads.

Only a few weeks prior to the planned transplant date Evies one and only 10/10 donor has pulled out of donating his stem cells. This news was totally unexpected and her family and friends are devastated.

In just over a week, the page has amassed almost 20,000 followers, many who are undergoing testing to see if they can help Evie.

RELATED: Heartbreaking pandemic impact on babies

Mum Tina said the family were devastated by the huge blow adding they had no idea why the donor changed their mind everything is confidential.

Evie has already been through so much, she told The Metro. She thought she had a donor and now she doesnt.

The donor pulling out is quite hard-hitting but from our point of view we just want to raise awareness of the stem cell register.

Initially doctors thought Evie may have leukaemia when she became sick during coronavirus lockdown earlier this year.

Then they were given the devastating diagnosis of aplastic anaemia.

Evie needs a stem cell transplant from a compatible donor to survive and has recently undergone an immunosuppressant course of treatment while the search for a new stem cell donor continues.

I need this transplant to save my life, Evie says in a video on the Facebook page. Please sign the register to help save my life.

Continue the conversation @RebekahScanlan | rebekah.scanlan@news.com.au

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Girls heartbreaking plea after her only bone marrow donor pulls out - NEWS.com.au

Bone Marrow Stem Cells Comments Off on Girls heartbreaking plea after her only bone marrow donor pulls out – NEWS.com.au | September 3rd, 2020

A distraught family in the UK has made an urgent plea after their little girl, who has a rare blood disorder, had her only bone marrow donor pull out at the last minute.

Just as she got prepared for the bone marrow transplant, Evie Hodgsons donor pulled out - devastating her family.

Her mother is now worried about the eight year olds future, as the chances of finding another donor are extremely slim.

In fact, theyre so slim that doctors are trying to find another course of treatment for Evie.

This is despite the fact that finding a stem cell transplant from a compatible donor is the best hope of curing the little girl.

Evie, from North Yorkshire, has deadly aplastic anaemia which was diagnosed after she developed a rash on her back that didnt fade.

She was found to have low blood platelet levels which doctors worried was leukaemia.

A biopsy found that Evie didnt have cancerous cells and she was diagnosed with the anaemia - her parents told she would need a bone marrow transplant.

A worldwide search was launched to find a donor after it was found that her family wasnt a match.

The search concluded after an anonymous donor was found who was a 10/10 match.

Next, they began to prepare for the transplant, which included both dental work and the removal of an ovary.

On August, the family got the devastating news that the donor had, in fact, pulled out.

We were devastated, it was a huge blow, mum Tina said.

We have no idea why the donor changed their mind. Everything is confidential.

Evie has already been through so much. She thought she had a donor and now she doesnt.

The donor pulling out is quite hard-hitting but from our point of view we just want to raise awareness of the stem cell register.

Its so easy to be a donor. Its just like giving blood, but you could save a childs life.

Some people dont even know they could be a match.

Its so easy to join the register but only about 1 per cent of the UK population is registered.

The eight-year-old is now to undergo an immunosuppressant course of treatment.

This is while the search for a donor continues.

The family has made a Facebook group to update people on her journey and to also raise awareness within the community.

The condition Evie has is life-threatening, Tina said.

She wont survive without a transplant.

Thats why we are desperately appealing for any many people as possible to register as a stem cell donor.

I need this transplant to save my life, Evie added.

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'Huge blow' as girl's only bone marrow donor in the world pulls out at last minute - 7NEWS.com.au

Bone Marrow Stem Cells Comments Off on ‘Huge blow’ as girl’s only bone marrow donor in the world pulls out at last minute – 7NEWS.com.au | September 3rd, 2020

One of the best performers on theS&P/ASX 200 Index(ASX: XJO) in August was the Mesoblast limited(ASX: MSB) share price.

The biotechnology companys shares recorded a stunning 40.5% gain during the month.

Investors were scrambling to buy the biotechnology companys shares in August due to positive developments relating to its remestemcel-L product candidate.

Remestemcel-L, also known as RYONCIL, is being developed as a treatment for paediatric steroid-resistance acute graft versus host disease (paediatric SR-aGvHD).

SR-aGvHD is an area of extreme need, particularly in vulnerable children under 12 years old where there is no approved therapy. It occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT) and has a very high mortality rate.

Remestemcel-L is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor.

It is administered to patients in a series of intravenous infusions and is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in SR-aGvHD. This is by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

In August the company hadits meeting with the Oncologic Drugs Advisory Committee (ODAC) of the U.S. FDA to discuss remestemcel-L as a potential treatment for paediatric SR-aGvHD.

The good news was that after some initial doubts, the ODAC was supportive of remestemcel-L and gave it the thumbs up.

While this doesnt necessarily guarantee that the U.S. FDA will approve it on 30 September, its opinions have a big sway on product approvals for cancer drugs. In light of this, the odds are certainly in Mesoblasts favour later this month.

I think Mesoblast is an exciting company and well worth keeping a close eye on.

However, due to its current valuation, I would class it as a hold and would sooner be a buyer of CSL Limited (ASX: CSL) shares.

I think they are trading at a more attractive level after a recent pullback.

When investing expert Scott Phillips has a stock tip, it can pay to listen. After all, the flagship Motley Fool Share Advisor newsletter he has run for more than eight years has provided thousands of paying members with stock picks that have doubled, tripled or even more.*

In this FREE STOCK REPORT, Scott just revealed what he believes are the 3 ASX stocks for the post COVID world that investors should buy right now while they still can. These stocks are trading at dirt-cheap prices and Scott thinks these could really go gangbusters as we move into the new normal.

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Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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The Mesoblast share price rocketed 40% higher in August: Is it too late to invest? - Motley Fool Australia

Bone Marrow Stem Cells Comments Off on The Mesoblast share price rocketed 40% higher in August: Is it too late to invest? – Motley Fool Australia | September 3rd, 2020

The European Society for Blood and Marrow Transplantation (EBMT), Europe's collaborative peer network of professionals working in the field of stem cell transplantation and cellular therapy, announced today the results of the phase III RACE trial during EBMTs virtual 46th Annual Meeting. Preliminary data show that adding Eltrombopag to standard immunosuppressive treatment is safe and increases response rates in patients with Severe Aplastic Anaemia (SAA).

SAA is a condition in which the bone marrow does not produce enough new blood cells. It is a rare, yet potentially fatal disease which can be treated with bone marrow transplantation or, for patients who are not eligible to receive a transplantation, with immunosuppressive treatment. The most commonly used immunosuppressive regimen includes horse ATG (hATG) in combination with Cyclosporine A (CsA). However, about 35% of patients do not respond to treatment or eventually relapse.

Eltrombopag is a thrombopoietin receptor agonist that was developed to stimulate thrombopoiesis (production of platelets), but it was subsequently shown to restore trilineage haematopoiesis. A previous single-arm study showed that adding Eltrombopag to standard immunosuppressive treatment appeared to improve the response rate as compared to the use of hATG plus CsA alone. The first results of the randomised controlled RACE trial now confirm that adding Eltrombopag to standard immunosuppression leads to significantly higher response rates compared to standard immunosuppressive treatment alone.

The RACE trial is sponsored by the EBMT with the financial support of Novartis and Pfizer. Professors. Rgis Peffault de Latour (Head of the French Reference Center for Aplastic Anemia and PNH, Saint-Louis Hospital, and University of Paris) and Antonio M. Risitano (Federico II University, Naples, and Head of Hematology and the BMT Unit, Ospedale Moscati, Avellino, Italy) served as Principal Investigators of the study, and they designed the study together with Professor Carlo Dufour (Head of the Hemato Oncology and Stem Cell Transplantation Department. G.Gaslini Childrens' Research Hospital, Genova, Italy). Under the energetic and efficient coordination of Sofie Terwel, the trial was successfully conducted by the RACE study team at the EBMT Clinical Trial Office. The study was presented by Prof. Peffault de Latour at the presidential symposium of EBMT's virtual Annual Meeting and was granted the Van Bekkum Award, the most prestigious EBMT award for the best abstract submitted to the physician's programme.

The international, investigator-driven, open-label, phase III, randomised trial evaluated 197 patients with SAA. Patients were aged 15 years or older, had acquired SAA, and had not received prior immunosuppressive treatment. Patients were randomised to receive either standard immunosuppression (hATG 40 mg/kg x4d and CsA 5 mg/kg/d) or standard immunosuppression + Eltrombopag at the dose of 150 mg/d from day +14 until 6 months (or 3 months, in case of early complete response). The primary endpoint of the study is complete response (CR) at 3 months, with CR being defined as haemoglobin 100 g/L, neutrophils 1.0 g/L and platelets 100g/L, according to standard international criteria.

It was shown that three months after treatment start, patients who received the combination of hATG, CsA plus Eltrombopag had a significantly higher complete response rate compared to patients treated with hATG and CsA alone. These higher response rates were sustained at 6 months. Moreover, Eltrombopag was generally well-tolerated, with a comparable occurrence of adverse events in the two treatment arms. This trial also shows that in this rare disease, large randomised trials can successfully be run in collaboration with many expert centres in Europe.

"Eltrombopag is registered in Europe for second line treatment of aplastic anaemia, so it is only available to patients who cannot receive bone marrow transplantation and have failed immunosuppressive treatment" explains Prof. Peffault de Latour. Prof. Risitano states: "The RACE trial data shows that eltrombopag increased response rates for nave SAA patients who are not eligible for hematopoietic stem cell transplantation. The RACE study team is continuing to follow up the trial participants up to two years and furthermore aims to set up a long-term follow-up study to monitor the effectiveness and safety of Eltrombopag up to ten years.". "The EBMT Clinical Trial Office is already actively working on this new project, which likely will provide the final evidence about the benefit of using triple therapy as initial treatment for Severe Aplastic Anemia." concludes Prof. Dufour.

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EBMT trial shows improvements in treatment of Severe Aplastic Anaemia - Science Codex

Bone Marrow Stem Cells Comments Off on EBMT trial shows improvements in treatment of Severe Aplastic Anaemia – Science Codex | September 3rd, 2020

Global Cell Isolation/Cell Separation Marketwas valued US$ XX Bn in 2018 and is expected to reach US$ 17.92 Bn by 2026, at a CAGR of around XX % during a forecast period.

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The report covers all the trends and technologies playing a major role in the growth of the Cell Isolation/Cell Separation market during the forecast period. It highlights the drivers, restraints, and opportunities expected to influence the market growth during 2019-2026.

Some of the market drivers for the cell isolation/cell separation market are increasing incidences & prevalence of chronic diseases with the aging population, technological advancement in cell isolation, growing demand for bio-pharmaceuticals, personalized medicine, and increasing stem cell research. Cell isolation or separation is a tool used to sort cells into a specific population from a heterogeneous group of cells without contamination. The use of cell isolation techniques helps to open the door of cell-based therapies and thereby improve the quality of treatment and clinical outcome.

However, the ethical issues regarding the isolation of embryonic stem cells and the high cost of cell separation instruments are expected to restrict the growth of this market during the forecast period.

Based on cell type, the human cell segment is expected to register a major revenue share in the cell isolation/cell separation market globally. Owing to increasing investments by public and private organizations for research on human cells, growing application areas of human stem cells, and the high frequency and growing incidence of diseases such as cancer.

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Based on the product, the consumables segment is expected to witness the fastest growth during the forecast period. Because of the increasing investments by companies to develop advanced products and the rising government initiatives for improving cell-based research are driving the growth of this segment.

North America region is expected to grow at a XX % rate of CAGR during the forecast period owing to increasing government support for cancer and stem cell research, the expanding biotechnology and biopharmaceutical industries and the increasing prevalence of chronic and infectious diseases in which cell isolation is required for diagnosis and treatment. Which results in, increase in demand for cell isolation products.

The objective of the report is to present a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, industry-validated market data and projections with a suitable set of assumptions and methodology. The report also helps in understanding Global Cell Isolation/Cell Separation Market dynamics, structure by identifying and analyzing the market segments and project the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, product portfolio, growth strategies, and regional presence. The report also provides PEST analysis, PORTERs analysis, and SWOT analysis to address the question of shareholders to prioritizing the efforts and investment in the near future to the emerging segment in Global Cell Isolation/Cell Separation Market.Scope of the Global Cell Isolation/Cell Separation Market

Global Cell Isolation/Cell Separation Market, By Product

Consumableso Reagents, Kits, Media, and Serao Beadso Disposables Instrumentso Centrifugeso Flow Cytometerso Magnetic-activated Cell Separator Systemso Filtration SystemsGlobal Cell Isolation/Cell Separation Market, By Cell Type

Human Cellso Differentiated Cellso Stem Cells Animal CellsGlobal Cell Isolation/Cell Separation Market, By Cell Source

Adipose Tissue Bone Marrow Cord Blood/Embryonic Stem CellsGlobal Cell Isolation/Cell Separation Market, By Technique

Centrifugation-based Cell Isolation Surface Marker-based Cell Isolation Filtration-based Cell IsolationGlobal Cell Isolation/Cell Separation Market, By Application

Biomolecule Isolation Cancer Research Stem Cell Research Tissue Regeneration & Regenerative Medicine In Vitro DiagnosticsGlobal Cell Isolation/Cell Separation Market, By End user

Research Laboratories and Institutes Hospitals and Diagnostic Laboratories Biotechnology and Biopharmaceutical Companies Other End UsersGlobal Cell Isolation/Cell Separation Market, By Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey players operating in the Global Cell Isolation/Cell Separation Market

Thermo Fisher Scientific Beckman Coulter Becton, Dickinson and Company GE Healthcare Merck KgaA Miltenyi Biotech pluriSelect STEMCELL Technologies Inc. Terumo BCT Bio-Rad Laboratories Inc.

MAJOR TOC OF THE REPORT

Chapter One: Cell Isolation/Cell Separation Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Cell Isolation/Cell Separation Market Competition, by Players

Chapter Four: Global Cell Isolation/Cell Separation Market Size by Regions

Chapter Five: North America Cell Isolation/Cell Separation Revenue by Countries

Chapter Six: Europe Cell Isolation/Cell Separation Revenue by Countries

Chapter Seven: Asia-Pacific Cell Isolation/Cell Separation Revenue by Countries

Chapter Eight: South America Cell Isolation/Cell Separation Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Cell Isolation/Cell Separation by Countries

Chapter Ten: Global Cell Isolation/Cell Separation Market Segment by Type

Chapter Eleven: Global Cell Isolation/Cell Separation Market Segment by Application

Chapter Twelve: Global Cell Isolation/Cell Separation Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Cell Isolation/Cell Separation Market Report at:https://www.maximizemarketresearch.com/market-report/global-cell-isolation-cell-separation-market/34136/

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Global Cell Isolation/Cell Separation Market Industry Analysis and Forecast (2019-2026), By-Product, Cell Type, Cell Source, Technique, Application,...

Bone Marrow Stem Cells Comments Off on Global Cell Isolation/Cell Separation Market Industry Analysis and Forecast (2019-2026), By-Product, Cell Type, Cell Source, Technique, Application,… | September 3rd, 2020

The globalRheumatoid Arthritis Stem Cell Therapymarketstudy presents an all in all compilation of the historical, current and future outlook of the market as well as the factors responsible for such a growth. With SWOT analysis, the business study highlights the strengths, weaknesses, opportunities and threats of each Rheumatoid Arthritis Stem Cell Therapy market player in a comprehensive way. Further, the Rheumatoid Arthritis Stem Cell Therapy market report emphasizes the adoption pattern of the Rheumatoid Arthritis Stem Cell Therapy across various industries.Request Sample Reporthttps://www.factmr.com/connectus/sample?flag=S&rep_id=1001The Rheumatoid Arthritis Stem Cell Therapy market report highlights the following players:The global market for rheumatoid arthritis stem cell therapy is highly fragmented. Examples of some of the key players operating in the global rheumatoid arthritis stem cell therapy market include Mesoblast Ltd., Roslin Cells, Regeneus Ltd, ReNeuron Group plc, International Stem Cell Corporation, TiGenix and others.

The Rheumatoid Arthritis Stem Cell Therapy market report examines the operating pattern of each player new product launches, partnerships, and acquisitions has been examined in detail.Important regions covered in the Rheumatoid Arthritis Stem Cell Therapy market report include:

North America (U.S., Canada)Latin America (Mexico, Brazil)Western Europe (Germany, Italy, U.K., Spain, France, Nordic countries, BENELUX)Eastern Europe (Russia, Poland, Rest Of Eastern Europe)Asia Pacific Excluding Japan (China, India, Australia & New Zealand)JapanMiddle East and Africa (GCC, S. Africa, Rest Of MEA)

The Rheumatoid Arthritis Stem Cell Therapy market report takes into consideration the following segments by treatment type:

Allogeneic Mesenchymal stem cellsBone marrow TransplantAdipose Tissue Stem Cells

The Rheumatoid Arthritis Stem Cell Therapy market report contain the following distribution channel:

HospitalsAmbulatory Surgical CentersSpecialty ClinicsHave Any Query? Ask our Industry Experts-https://www.factmr.com/connectus/sample?flag=AE&rep_id=1001

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The Rheumatoid Arthritis Stem Cell Therapy market report offers a plethora of insights which include:

Changing consumption pattern among individuals globally.Historical and future progress of the global Rheumatoid Arthritis Stem Cell Therapy market.Region-wise and country-wise segmentation of the Rheumatoid Arthritis Stem Cell Therapy market to understand the revenue, and growth lookout in these areas.Accurate Year-on-Year growth of the global Rheumatoid Arthritis Stem Cell Therapy market.Important trends, including proprietary technologies, ecological conservation, and globalization affecting the global Rheumatoid Arthritis Stem Cell Therapy market.

The Rheumatoid Arthritis Stem Cell Therapy market report answers important questions which include:

Which regulatory authorities have granted approval to the application of Rheumatoid Arthritis Stem Cell Therapy in Health industry?How will the global Rheumatoid Arthritis Stem Cell Therapy market grow over the forecast period?Which end use industry is set to become the leading consumer of Rheumatoid Arthritis Stem Cell Therapy by 2028?What manufacturing techniques are involved in the production of the Rheumatoid Arthritis Stem Cell Therapy?Which regions are the Rheumatoid Arthritis Stem Cell Therapy market players targeting to channelize their production portfolio?Get Full Access of the Report @https://www.factmr.com/report/1001/rheumatoid-arthritis-stem-cell-therapy-market

Pertinent aspects this study on the Rheumatoid Arthritis Stem Cell Therapy market tries to answer exhaustively are:

What is the forecast size (revenue/volumes) of the most lucrative regional market? What is the share of the dominant product/technology segment in the Rheumatoid Arthritis Stem Cell Therapy market? What regions are likely to witness sizable investments in research and development funding? What are Covid 19 implication on Rheumatoid Arthritis Stem Cell Therapy market and learn how businesses can respond, manage and mitigate the risks? Which countries will be the next destination for industry leaders in order to tap new revenue streams? Which new regulations might cause disruption in industry sentiments in near future? Which is the share of the dominant end user? Which region is expected to rise at the most dominant growth rate? Which technologies will have massive impact of new avenues in the Rheumatoid Arthritis Stem Cell Therapy market? Which key end-use industry trends are expected to shape the growth prospects of the Rheumatoid Arthritis Stem Cell Therapy market? What factors will promote new entrants in the Rheumatoid Arthritis Stem Cell Therapy market? What is the degree of fragmentation in the Rheumatoid Arthritis Stem Cell Therapy market, and will it increase in coming years?Why Choose Fact.MR?

Fact.MR follows a multi- disciplinary approach to extract information about various industries. Our analysts perform thorough primary and secondary research to gather data associated with the market. With modern industrial and digitalization tools, we provide avant-garde business ideas to our clients. We address clients living in across parts of the world with our 24/7 service availability.

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Global Rheumatoid Arthritis Stem Cell Therapy Market Dynamics, Forecast, Analysis and Supply Demand 2018 to 2028 - Scientect

Bone Marrow Stem Cells Comments Off on Global Rheumatoid Arthritis Stem Cell Therapy Market Dynamics, Forecast, Analysis and Supply Demand 2018 to 2028 – Scientect | September 3rd, 2020

DUBLIN, Sept. 2, 2020 /PRNewswire/ -- The "Global Cord Blood Banking Industry Report 2020" report has been added to ResearchAndMarkets.com's offering.

This report presents the number of cord blood units stored in inventory by the largest cord blood banks worldwide and the number of cord blood units (CBUs) released by registries across the world for hematopoietic stem cell (HSC) transplantation. Although cord blood is now used to treat more than 80 different diseases, this number could substantially expand if applications related to regenerative medicine start receiving approvals in major healthcare markets worldwide.

From the early 1900s through the mid-2000s, the global cord blood banking industry expanded rapidly, with companies opening for business in all major markets worldwide. From 2005 to 2010, the market reached saturation and stabilized.

Then, from 2010 to 2020, the market began to aggressively consolidate. This has created both serious threats and unique opportunities within the industry.

Serious threats to the industry include low rates of utilization for stored cord blood, expensive cord blood transplantation procedures, difficulty educating obstetricians about cellular therapies, and an increasing trend toward industry consolidation. There are also emerging opportunities for the industry, such as accelerated regulatory pathways for cell therapies in leading healthcare markets worldwide and expanding applications for cell-based therapies. In particular, MSCs from cord tissue (and other sources) are showing intriguing promise in the treatment and management of COVID-19.

Cord Blood Industry Trends

Within recent years, new themes have been impacting the industry, including the pairing of stem cell storage services with genetic and genomic testing services, as well as reproductive health services. Cord blood banks are diversifying into new types of stem cell storage, including umbilical cord tissue storage, placental blood and tissue, amniotic fluid and tissue, and dental pulp. Cord blood banks are also investigating means of becoming integrated therapeutic companies. With hundreds of companies offering cord blood banking services worldwide, maturation of the market means that each company is fighting harder for market share.

Growing numbers of investors are also entering the marketplace, with M&A activity accelerating in the U.S. and abroad. Holding companies are emerging as a global theme, allowing for increased operational efficiency and economy of scale. Cryoholdco has established itself as the market leader within Latin America. Created in 2015, Cryoholdco is a holding company that will control nearly 270,000 stem cell units by the end of 2020. It now owns a half dozen cord blood banks, as well as a dental stem cell storage company.

Globally, networks of cord blood banks have become commonplace, with Sanpower Group establishing its dominance in Asia. Although Sanpower has been quiet about its operations, it holds 4 licenses out of only 7 issued provincial-level cord blood bank licenses in China. It has reserved over 900,000 cord blood samples in China, and its reserves amount to over 1.2 million units when Cordlife' reserves within Southeast Asian countries are included. This positions Sanpower Group and it's subsidiary Nanjing Cenbest as the world's largest cord blood banking operator not only in China and Southeast Asia but in the world.

The number of cord blood banks in Europe has dropped by more than one-third over the past ten years, from approximately 150 to under 100. The industry leaders in this market segment include FamiCord Group, who has executed a dozen M&A transactions, and Vita34, who has executed approximately a half dozen. Stemlab, the largest cord blood bank in Portugal, also executed three acquisition deals prior to being acquired by FamiCord. FamiCord is now the leading stem cell bank in Europe and one of the largest worldwide.

Cord Blood Expansion Technologies

Because cord blood utilization is largely limited to use in pediatric patients, growing investment is flowing into ex vivo cord blood expansion technologies. If successful, this technology could greatly expand the market potential for cord blood, encouraging its use within new markets, such as regenerative medicine, aging, and augmented immunity.

Key strategies being explored for this purpose include:

Currently, Gamida Cell, Nohla Therapeutics, Excellthera, and Magenta Therapeutics have ex vivo cord blood expansion products proceeding through clinical trials. Growing numbers of investors have also entered the cord blood banking marketplace, led by groups such as GI Partners, ABS Capital Partners & HLM Management, KKR & Company, Bay City Capital, GTCR, LLC, and Excalibur.

Cord Blood Banking by Region

Within the United States, most of the market share is controlled by three major players: Cord Blood Registry (CBR), Cryo-Cell, and ViaCord. CBR has been traded twice, once in 2015 to AMAG Pharmaceuticals for $700 million and again in 2018 to GI Partners for $530 million. CBR also bought Natera's Evercord Cord Blood Banking business in September 2019. In total, CBR controls over 900,000 cord blood and tissue samples, making it one of the largest cord blood banks worldwide.

In China, the government controls the industry by authorizing only one cord blood bank to operate within each province, and official government support, authorization, and permits are required. Importantly, the Chinese government announced in late 2019 that it will be issuing new licenses for the first time, expanding from the current 7 licensed regions for cord blood banking to up to 19 regions, including Beijing.

In Italy and France, it is illegal to privately store one's cord blood, which has fully eliminated the potential for a private market to exist within the region. In Ecuador, the government created the first public cord blood bank and instituted laws such that private cord blood banks cannot approach women about private cord blood banking options during the first six months of pregnancy. This created a crisis for private banks, forcing most out of business.

Recently, India's Central Drugs Standard Control Organization (CDSCO) restricted commercial banking of stem cells from most biological materials, including cord tissue, placenta, and dental pulp stem cells - leaving only umbilical cord blood banking as permitted and licensed within the country.

While market factors vary by geography, it is crucial to have a global understanding of the industry, because research advances, clinical trial findings, and technology advances do not know international boundaries. The cord blood market is global in nature and understanding dynamics within your region is not sufficient for making strategic, informed, and profitable decisions.

Overall, the report provides the reader with the following details and answers the following questions:

1. Number of cord blood units cryopreserved in public and private cord blood banks globally2. Number of hematopoietic stem cell transplants (HSCTs) globally using cord blood cells3. Utilization of cord blood cells in clinical trials for developing regenerative medicines4. The decline of the utilization of cord blood cells in HSC transplantations since 20055. Emerging technologies to influence the financial sustainability of public cord blood banks6. The future scope for companion products from cord blood7. The changing landscape of cord blood cell banking market8. Extension of services by cord blood banks9. Types of cord blood banks10. The economic model of public cord blood banks11. Cost analysis for public cord blood banks12. The economic model of private cord blood banks13. Cost analysis for private cord blood banks14. Profit margins for private cord blood banks15. Pricing for processing and storage in private banks16. Rate per cord blood unit in the U.S. and Europe17. Indications for the use of cord blood-derived HSCs for transplantations18. Diseases targeted by cord blood-derived MSCs in regenerative medicine19. Cord blood processing technologies20. Number of clinical trials, number of published scientific papers and NIH funding for cord blood research21. Transplantation data from different cord blood registries

Key questions answered in this report are:

1. What are the strategies being considered for improving the financial stability of public cord blood banks?2. What are the companion products proposed to be developed from cord blood?3. How much is being spent on processing and storing a unit of cord blood?4. How much does a unit of cryopreserved cord blood unit fetch on release?5. Why do most public cord blood banks incur a loss?6. What is the net profit margin for a private cord blood bank?7. What are the prices for processing and storage of cord blood in private cord blood banks?8. What are the rates per cord blood units in the U.S. and Europe?9. What are the revenues from cord blood sales for major cord blood banks?10. Which are the different accreditation systems for cord blood banks?11. What are the comparative merits of the various cord blood processing technologies?12. What is to be done to increase the rate of utilization of cord blood cells in transplantations?13. Which TNC counts are preferred for transplantation?14. What is the number of registered clinical trials using cord blood and cord tissue?15. How many clinical trials are involved in studying the expansion of cord blood cells in the laboratory?16. How many matching and mismatching transplantations using cord blood units are performed on an annual basis?17. What is the share of cord blood cells used for transplantation from 2000 to 2020?18. What is the likelihood of finding a matching allogeneic cord blood unit by ethnicity?19. Which are the top ten countries for donating cord blood?20. What are the diseases targeted by cord blood-derived MSCs within clinical trials?

Key Topics Covered

1. REPORT OVERVIEW1.1 Statement of the Report1.2 Executive Summary1.3 Introduction1.3.1 Cord Blood: An Alternative Source for HPSCs1.3.2 Utilization of Cord Blood Cells in Clinical Trials1.3.3 The Struggle of Cord Blood Banks1.3.4 Emerging Technologies to Influence Financial Sustainability of Banks1.3.4.1 Other Opportunities to Improve Financial Stability1.3.4.2 Scope for Companion Products1.3.5 Changing Landscape of Cord Blood Cell Banking Market1.3.6 Extension of Services by Cord Blood Banks

2. CORD BLOOD & CORD BLOOD BANKING: AN OVERVIEW2.1 Cord Blood Banking (Stem Cell Banking)2.1.1 Public Cord Blood Banks2.1.1.1 Economic Model of Public Cord Blood Banks2.1.1.2 Cost Analysis for Public Banks2.1.1.3 Relationship between Costs and Release Rates2.1.2 Private Cord Blood Banks2.1.2.1 Cost Analysis for Private Cord Blood Banks2.1.2.2 Economic Model of Private Banks2.1.3 Hybrid Cord Blood Banks2.2 Globally Known Cord Blood Banks2.2.1 Comparing Cord Blood Banks2.2.2 Cord Blood Banks in the U.S.2.2.3 Proportion of Public, Private and Hybrid Banks2.3 Percent Share of Parents of Newborns Storing Cord Blood by Country/Region2.4 Pricing for Processing and Storage in Commercial Banks2.4.1 Rate per Cord Blood Unit in the U.S. and Europe2.5 Cord Blood Revenues for Major Cord Blood Banks

3. CORD BLOOD BANK ACCREDITATIONS3.1 American Association of Blood Banks (AABB)3.2 Foundation for the Accreditation of Cellular Therapy (FACT)3.3 FDA Registration3.4 FDA Biologics License Application (BLA) License3.5 Investigational New Drug (IND) for Cord Blood3.6 Human Tissue Authority (HTA)3.7 Therapeutic Goods Act (TGA) in Australia3.8 International NetCord Foundation3.9 AABB Accredited Cord Blood Facilities3.10 FACT Accreditation for Cord Blood Banks

4. APPLICATIONS OF CORD BLOOD CELLS4.1 Hematopoietic Stem Cell Transplantations with Cord Blood Cells4.2 Cord Cells in Regenerative Medicine

5. CORD BLOOD PROCESSING TECHNOLOGIES5.1 The Process of Separation5.1.1 PrepaCyte-CB5.1.2 Advantages of PrepaCyte-CB5.1.3 Treatment Outcomes with PrepaCyte-CB5.1.4 Hetastarch (HES)5.1.5 AutoXpress (AXP)5.1.6 SEPAX5.1.7 Plasma Depletion Method (MaxCell Process)5.1.8 Density Gradient Method5.2 Comparative Merits of Different Processing Methods5.2.1 Early Stage HSC Recovery by Technologies5.2.2 Mid Stage HSC (CD34+/CD133+) Recovery from Cord Blood5.2.3 Late Stage Recovery of HSCs from Cord Blood5.3 HSC (CD45+) Recovery5.4 Days to Neutrophil Engraftment by Technology5.5 Anticoagulants used in Cord Blood Processing5.5.1 Type of Anticoagulant and Cell Recovery Volume5.5.2 Percent Cell Recovery by Sample Size5.5.3 TNC Viability by Time Taken for Transport and Type of Anticoagulant5.6 Cryopreservation of Cord Blood Cells5.7 Bioprocessing of Umbilical Cord Tissue (UCT)5.8 A Proposal to Improve the Utilization Rate of Banked Cord Blood

6. CORD BLOOD CLINICAL TRIALS, SCIENTIFIC PUBLICATIONS & NIH FUNDING6.1 Cord Blood Cells for Research6.2 Cord Blood Cells for Clinical Trials6.2.1 Number of Clinical Trials involving Cord Blood Cells6.2.2 Number of Clinical Trials using Cord Blood Cells by Geography6.2.3 Number of Clinical Trials by Study Type6.2.4 Number of Clinical Trials by Study Phase6.2.5 Number of Clinical Trials by Funder Type6.2.6 Clinical Trials Addressing Indications in Children6.2.7 Select Three Clinical Trials Involving Children6.2.7.1 Sensorineural Hearing Loss (NCT02038972)6.2.7.2 Autism Spectrum (NCT02847182)6.2.7.3 Cerebral Palsy (NCT01147653)6.2.8 Clinical Trials for Neurological Diseases using Cord Blood and Cord Tissue6.2.9 UCB for Diabetes6.2.10 UCB in Cardiovascular Clinical Trials6.2.11 Cord Blood Cells for Auto-Immune Diseases in Clinical Trials6.2.12 Cord Tissue Cells for Orthopedic Disorders in Clinical Trials6.2.13 Cord Blood Cells for Other Indications in Clinical Trials6.3 Major Diseases Addressed by Cord Blood Cells in Clinical Trials6.4 Clinical Trials using Cord Tissue-Derived MSCs6.5 Ongoing Clinical Trials using Cord Tissue6.5.1 Cord Tissue-Based Clinical Trials by Geography6.5.2 Cord Tissue-Based Clinical Trials by Phase6.5.3 Cord Tissue-Based Clinical Trials by Sponsor Types6.5.4 Companies Sponsoring in Trials using Cord Tissue-Derived MSCs6.6 Wharton's Jelly-Derived MSCs in Clinical Trials6.6.1 Wharton's Jelly-Based Clinical Trials by Phase6.6.2 Companies Sponsoring Wharton's Jelly-Based Clinical Trials6.7 Clinical Trials Involving Cord Blood Expansion Studies6.7.1 Safe and Feasible Expansion Protocols6.7.2 List of Clinical Trials involved in the Expansion of Cord Blood HSCs6.7.3 Expansion Technologies6.8 Scientific Publications on Cord Blood6.9 Scientific Publications on Cord Tissue6.10 Scientific Publications on Wharton's Jelly-Derived MSCs6.11 Published Scientific Papers on Cord Blood Cell Expansion6.12 NIH Funding for Cord Blood Research

7. PARENT'S AWARENESS AND ATTITUDE TOWARDS CORD BLOOD BANKING7.1 Undecided Expectant Parents7.2 The Familiar Cord Blood Banks Known by the Expectant Parents7.3 Factors Influencing the Choice of a Cord Blood Bank

8. CORD BLOOD: AS A TRANSPLANTATION MEDICINE8.1 Comparisons of Cord Blood to other Allograft Sources8.1.1 Major Indications for HCTs in the U.S.8.1.2 Trend in Allogeneic HCT in the U.S. by Recipient Age8.1.3 Trends in Autologous HCT in the U.S. by Recipient Age8.2 HCTs by Cell Source in Adult Patients8.2.1 Transplants by Cell Source in Pediatric Patients8.3 Allogeneic HCTs by Cell Source8.3.1 Unrelated Donor Allogeneic HCTs in Patients &lessThan;18 Years8.4 Likelihood of Finding an Unrelated Cord Blood Unit by Ethnicity8.4.1 Likelihood of Finding an Unrelated Cord Blood Unit for Patients &lessThan;20 Years8.5 Odds of using a Baby's Cord Blood8.6 Cord Blood Utilization Trends8.7 Number of Cord Blood Donors Worldwide8.7.1 Number of CBUs Stored Worldwide8.7.2 Cord Blood Donors by Geography8.7.2.1 Cord Blood Units Stored in Different Geographies8.7.2.2 Number of Donors by HLA Typing8.7.3 Searches Made by Transplant Patients for Donors/CBUs8.7.4 Types of CBU Shipments (Single/Double/Multi)8.7.5 TNC Count of CBUs Shipped for Children and Adult Patients8.7.6 Shipment of Multiple CBUs8.7.7 Percent Supply of CBUs for National and International Patients8.7.8 Decreasing Number of CBU Utilization8.8 Top Ten Countries in Cord Blood Donation8.8.1 HLA Typed CBUs by Continent8.8.2 Percentage TNC of Banked CBUs8.8.3 Total Number of CBUs, HLA-Typed Units by Country8.9 Cord Blood Export/Import by the E.U. Member States8.9.1 Number of Donors and CBUs in Europe8.9.2 Number of Exports/Imports of CBUs in E.U.8.10 Global Exchange of Cord Blood Units

9. CORD BLOOD CELLS AS THERAPEUTIC CELL PRODUCTS IN CELL THERAPY9.1 MSCs from Cord Blood and Cord Tissue9.1.1 Potential Neurological Applications of Cord Blood-Derived Cells9.1.2 Cord Tissue-Derived MSCs for Therapeutic use9.1.2.1 Indications Targeted by UCT-MSCs in Clinical Trials9.2 Current Consumption of Cord Blood Units by Clinical Trials9.3 Select Cord Blood Stem Cell Treatments in Clinical Trials9.3.1 Acquired Hearing Loss (NCT02038972)9.3.2 Autism (NCT02847182)9.3.3 Cerebral Palsy (NCT03087110)9.3.4 Hypoplastic Left Heart Syndrome (NCT01856049)9.3.5 Type 1 Diabetes (NCT00989547)9.3.6 Psoriasis (NCT03765957)9.3.7 Parkinson's Disease (NCT03550183)9.3.8 Signs of Aging (NCT04174898)9.3.9 Stroke (NCT02433509)9.3.10 Traumatic Brain Injury (NCT01451528)

10. MARKET ANALYSIS10.1 Public vs. Private Cord Blood Banking Market10.2 Cord Blood Banking Market by Indication

11. PROFILES OF SELECT CORD BLOOD BANKS11.1 AllCells11.1.1 Whole Blood11.1.2 Leukopak11.1.3 Mobilized Leukopak11.1.4 Bone Marrow11.1.5 Cord Blood11.2 AlphaCord LLC11.2.1 NextGen Collection System11.3 Americord Registry, Inc.11.3.1 Cord Blood 2.011.3.2 Cord Tissue11.3.3 Placental Tissue 2.011.4 Be The Match11.4.1 Hub of Transplant Network11.4.2 Partners of Be The Match11.4.3 Allogeneic Cell Sources in Be The Match Registry11.4.4 Likelihood of a Matched Donor on Be The Match by Ethnic Background11.5 Biocell Center Corporation11.5.1 Chorionic villi after Delivery11.5.2 Amniotic Fluid and Chorionic Villi during Pregnancy11.6 BioEden Group, Inc.11.6.1 Differences between Tooth Cells and Umbilical Cord Cells11.7 Biovault Family11.7.1 Personalized Cord Blood Processing11.8 Cell Care11.9 Cells4Life Group, LLP11.9.1 Cells4Life's pricing11.9.2 TotiCyte Technology11.9.3 Cord Blood Releases11.10 Cell-Save11.11 Center for International Blood and Marrow Transplant Research (CIBMTR)11.11.1 Global Collaboration11.11.2 Scientific Working Committees11.11.3 Medicare Clinical Trials and Studies11.11.4 Cellular Therapy11.12 Crio-Cell International, Inc.11.12.1 Advanced Collection Kit11.12.2 Prepacyte-CB11.12.3 Crio-Cell International's Pricing11.12.4 Revenue for Crio-Cell International11.13 Cord Blood Center Group11.13.1 Cord Blood Units Released11.14 Cordlife Group, Ltd.11.14.1 Cordlife's Cord Blood Release Track Record11.15 Core23 Biobank11.16 Cord Blood Registry (CBR)11.17 CordVida11.18 Crioestaminal11.18.1 Cord Blood Transplantation in Portugal11.19 Cryo-Cell International, Inc.11.19.1 Processing Method11.19.2 Financial Results of the Company11.20 CryoHoldco11.21 Cryoviva Biotech Pvt. Ltd11.22 European Society for Blood and Bone Marrow Transplantation (EBMT)11.22.1 EBMT Transplant Activity11.23 FamiCord Group11.24 GeneCell International11.25 Global Cord Blood Corporation11.25.1 The Company's Business11.26 HealthBaby Hong Kong11.26.1 BioArchive System Service Plan11.26.2 MVE Liquid Nitrogen System11.27 HEMAFUND11.28 Insception Lifebank11.29 LifebankUSA11.29.1 Placental Banking11.30 LifeCell International Pvt. Ltd.11.31 MiracleCord, Inc.11.32 Maze Cord Blood Laboratories11.33 New England Cord Blood Bank, Inc.11.34 New York Cord Blood Center (NYBC)11.34.1 Products11.34.2 Laboratory Services11.35 PacifiCord11.35.1 FDA-Approved Sterile Collection Bags11.35.2 AXP Processing System11.35.3 BioArchive System11.36 ReeLabs Pvt. Ltd.11.37 Smart Cells International, Ltd.11.38 Stem Cell Cryobank11.39 StemCyte, Inc.11.39.1 StemCyte Sponsored Clinical Trials11.39.1.1 Spinal Cord Injury Phase II11.39.1.2 Other Trials11.40 Transcell Biolife11.40.1 ScellCare11.40.2 ToothScell11.41 ViaCord11.42 Vita 34 AG11.43 World Marrow Donor Association (WMDA)11.43.1 Search & Match Service11.44 Worldwide Network for Blood & Marrow Transplantation (WBMT)

For more information about this report visit https://www.researchandmarkets.com/r/7bm9lx

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global Cord Blood Banking Market 2020 with Analysis of 44 Industry Players - PRNewswire

Spinal Cord Stem Cells Comments Off on Global Cord Blood Banking Market 2020 with Analysis of 44 Industry Players – PRNewswire | September 3rd, 2020

Despite significant progress in treating cancer in recent years, the need for further improvements has persisted particularly for some of the most challenging forms of the disease, such as lung cancer. Lung cancer is one of the most common cancers, and is the leading cause of cancer death in both men and women.

The majority of lung cancer cases are non-small cell lung cancer (NSCLC), a complex disease that can affect each patient differently. Most cases of NSCLC are not diagnosed until the disease is advanced meaning it has metastasized or spread which can make it more challenging to treat.

The impact of lung cancer, and advanced NSCLC in particular, continues to be felt across our communities, explained Andrea Ferris, president and chairman of LUNGevity Foundation. While every persons experience with the disease is unique, many patients hope they can retain a sense of normalcy in their lives and are seeking more treatment options that offer a chance at a longer life.

Research Driving New Progress for Certain Patients

Researchers have accelerated their pursuit of new and differentiated approaches that address this critical unmet need, focusing on options that may offer patients a chance at a longer life. One area of research that has shown potential is combining treatments, such as immunotherapies, for certain patients with previously untreated advanced disease.

Hossein Borghaei, D.O., chief of thoracic medical oncology at Fox Chase Cancer Center in Philadelphia explains, Progress in treating advanced lung cancer has led to more options for patients with newly diagnosed advanced NSCLC. Some of the most recent developments in the field of immunotherapy are particularly exciting.

One example is the U.S. Food and Drug Administrations approval of the first and only dual immunotherapy approach for newly diagnosed patients. Opdivo (nivolumab) is a prescription medicine used in combination with Yervoy (ipilimumab) for adults with advanced stage NSCLC that has spread to other parts of your body (metastatic) and tests positive for PD-L1 and do not have an abnormal EGFR or ALK gene.

Opdivo can cause problems that can sometimes become serious or life threatening and can lead to death. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; and severe infusion reactions; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Additional serious side effects of Yervoy alone include: nerve problems that can lead to paralysis; eye problems; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Please see Important Facts about side effects for Opdivo and Yervoy below.

Opdivo and Yervoy work with your immune system to help fight cancer in two ways. Yervoy stimulates the kind of cells that help fight cancer, while Opdivo may help these cells to find and fight the cancer cells again. While doing so, Opdivo and Yervoy can also affect healthy cells. These problems can sometimes become serious or life threatening and can lead to death. These problems may happen anytime during treatment or even after treatment has ended. Some of these problems may happen more often when Opdivo is used in combination with Yervoy.

Clinical Trial Findings: A Chance to Live Longer

Opdivo + Yervoy was studied in a clinical trial and compared to platinum-based chemotherapy among certain patients with previously untreated, advanced NSCLC that tested positive for PD-L1.

In the trial, 396 patients received Opdivo + Yervoy and 397 patients received platinum-based chemotherapy. Patients who were treated with Opdivo + Yervoy lived longer than those treated with platinum-based chemotherapy:

An additional analysis showed:

The data supporting this dual immunotherapy approach are encouraging, particularly as one third of the patients who responded to treatment with Opdivo + Yervoy were still alive at three years, said Dr. Borghaei. Further, Opdivo + Yervoy offers a non-chemotherapy option, which can be important to some patients.

The most common side effects of Opdivo, when used in combination with Yervoy, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness. Please see Important Facts about side effects for Opdivo and Yervoy below.

Evolving Outlooks and Adapting Support for Patients

Facing a lung cancer diagnosis and beginning treatment can be life-altering in many ways and todays unique environment as a result of the coronavirus has brought about additional considerations for patients, caregivers and the broader healthcare community, with telemedicine and other forms of remote support playing an increasingly vital role.

Patients should know there are resources available and ways to stay connected, even during times when maintaining physical distance from others is important, said Ferris. We have transformed many of our patient support and education offerings into virtual formats, which we are updating frequently to provide the most recent information and reach and connect as many people as possible.

Dr. Borghaei also urges patients to reach out to their doctor or care team to learn about and take advantage of available remote support offerings. Advances in cancer research are still happening every day, with Opdivo + Yervoy being one example. Its as important as ever that people diagnosed with lung cancer speak with their doctor to fully understand their treatment options. While how we deliver care might look different now in some ways, our commitment to helping patients live longer hasnt changed.

To learn more about Opdivo + Yervoy, please visit http://www.Opdivo.com.

INDICATION

OPDIVO (nivolumab) is a prescription medicine used in combination with YERVOY (ipilimumab) as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

Important Safety Information for OPDIVO (nivolumab) + YERVOY (ipilimumab)

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.

YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.

Serious side effects may include: Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath. Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness. Liver problems (hepatitis). Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); drowsiness; dark urine (tea colored); bleeding or bruising more easily than normal; feeling less hungry than usual; and decreased energy. Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include: headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; hair loss; feeling cold; constipation; voice gets deeper; and excessive thirst or lots of urine. Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite. Skin problems. Signs of these problems may include: rash; itching; skin blistering; and ulcers in the mouth or other mucous membranes. Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include: headache; fever; tiredness or weakness; confusion; memory problems; sleepiness; seeing or hearing things that are not really there (hallucinations); seizures; and stiff neck. Problems in other organs. Signs of these problems may include: changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; and chest pain.

Additional serious side effects observed during a separate study of YERVOY alone include: Nerve problems that can lead to paralysis. Symptoms of nerve problems may include: unusual weakness of legs, arms, or face; and numbness or tingling in hands or feet. Eye problems. Symptoms may include: blurry vision, double vision, or other vision problems; and eye pain or redness.

Get medical help immediately if you develop any of these symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have a serious side effect, your healthcare team may also need to delay or completely stop your treatment.

OPDIVO and OPDIVO + YERVOY can cause serious side effects, including: Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out. Graft-versus-host disease, a complication that can happen after receiving a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), may be severe, and can lead to death, if you receive YERVOY either before or after transplant. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.

Pregnancy and Nursing: Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. If you are a female who is able to become pregnant, your healthcare provider should do a pregnancy test before you start receiving OPDIVO. Females who are able to become pregnant should use an effective method of birth control during treatment and for at least 5 months after the last dose. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment. You or your healthcare provider should contact Bristol Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy. Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869. Before receiving treatment, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment and for 5 months after the last dose.

Tell your healthcare provider about: Your health problems or concerns if you: have immune system problems such as autoimmune disease, Crohns disease, ulcerative colitis, lupus, or sarcoidosis; have had an organ transplant; have lung or breathing problems; have liver problems; or have any other medical conditions. All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO and YERVOY.

2020 Bristol-Myers Squibb Company.

OPDIVO and YERVOY are registered trademarks of Bristol-Myers Squibb Company.

7356US2001251-01 08/20

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(new) The Science of Survival: Evolving Research in Advanced Non-Small Cell Lung Cancer - Reuters

Skin Stem Cells Comments Off on (new) The Science of Survival: Evolving Research in Advanced Non-Small Cell Lung Cancer – Reuters | September 3rd, 2020

On April 15, 2002, the FDA approved a temporary treatment for wrinkles that would revolutionize aging. All of a sudden, you could waltz into a derms office and get your frown lines ironed out faster than it would take to iron an actual shirt. It was called botulinum toxin, Botox for short.

Eighteen years later, a few units of Botox every three months has become the norm for millions around the world (more than seven million yearly in the U.S. alone). Now, if someone had told your grandparents, or even your parents, 20 years ago that people would be getting their foreheads frozen to look younger, they likely would have scoffed at the idea. So just imagine what other wild fixes could be coming to a medi-spa near you.

Its exciting to think about how the next 10 years will look, says Dr. Rohan Bissoondath, medical director of Calgarys Preventous Cosmetic Medicine clinic. With lifespan increasing, people are routinely going to be living into their hundreds, so we want to look great as well. From magic pills to creams that mimic injections, we take a look at the incredible innovations on the horizon.

You wont need surgery to lift your face

The way science is progressing, facelifts are set to become obsolete, says Dr. Lisa Kellett of Torontos DLK on Avenue. I think that the gold standard will eventually be finding ways to regenerate and kick-start our own collagen instead of doing a facelift. Kellett is already trying out cutting-edge technology to accomplish this, such as a laser that delivers growth factors right in the dermis to regenerate tissue. Its pretty snazzy stuff, but she anticipates even greater advances in coming years. I think well be able to use stem cells in conjunction with technology to regenerate collagen I think thats what well be doing one day.

Youll (hopefully) be able to nix wrinkles without needles

Botox in a cream? This has been in the pipeline for a while, says Bissoondath. The challenge is getting the molecules to penetrate the skin so that they can act on the muscle. Maybe on crows feet because its a thinner area, thinner muscles; that may be an area where we see some utility for it, but its still out there. Topical Botox had some success in trials, but scientists still have kinks to work out. In the meantime, a Botox cream might be beneficial even if it doesnt reach muscles, says Bissoondath. I see the potential for having it in a cream and applying it to the whole face, not necessarily affecting facial expressions, but giving an improved glow and better skin quality.

Therell be more all-in-one solutions

If you want to smooth, you get Botox. If you want to brighten, you get IPL. If you want to tighten, you get Thermage. But what if there was a treatment that did it all? I think thats the future of aging, says Kellett, who is just about to launch such a treatment at her clinic. Marketed as the next generation of laser and light-based platform technology, Etherea MX is a multiple modality device that can tackle everything from dark spots and skin laxity to textural issues and wrinkles. It means that when patients come in, theyre not just doing one thing, says the doc. Instead, in the same appointment, shes able to address a variety of concerns with a single machine.

Youll be able to take a pill instead of hitting the gym

OK, this is very cool. Something I think is possible is a pill to replace exercise, says Bissoondath, who adds that this could be developed in the not so distant future. With the advances were making in understanding the functions of our body down to the cellular level and intracellular level, and understanding how our mitochondria actually ages, were looking at ways now where we can manipulate that from a pill perspective. The pill wouldnt deliver all the benefits of physical activity, such as the positive impact on our mood, but it would replicate its effects on our body. It wont take the place of walking around outside and soaking up nature it cant do the mental part of it. But as far as the physiologic, biochemical part of it, were really understanding that better and making big strides. Its exciting.

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Exciting new technologies could change the way we age - TheSpec.com

Skin Stem Cells Comments Off on Exciting new technologies could change the way we age – TheSpec.com | September 3rd, 2020

The success of approved stem cell therapies has caused a surge in interest of biopharma developers in this field; many innovator companies are currently progressing proprietary leads across different phases of clinical development, with cautious optimism

Roots Analysis has announced the addition of Global Stem Cells Market: Focus on Clinical Therapies, 20202030 (Based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent)) report to its list of offerings.

There is a growing body of evidence supporting the vast applicability and superiority of treatment outcomes of stem cell therapies, compared to conventional treatment options. In fact, the unmet needs within this domain have spurred the establishment of many start-ups in recent years.

To order this 500+ page report, which features 185+ figures and 220+ tables, please visit this link

Over 280 stem cell therapies are under development, most of which are allogeneic productsMore than 50% of the pipeline candidates are in the mid to late phase trials (phase II and above), and allogenic therapies (majority of which are derived from the bone marrow) make up 65% of the pipeline.

70% of pipeline candidates are based on mesenchymal stem cellsIt is worth highlighting that the abovementioned therapies are designed to treat musculoskeletal (22%), neurological (21%) and cardiovascular (15%) disorders. On the other hand, hematopoietic stem cell-based products are mostly being evaluated for the treatment of oncological disorders, primarily hematological malignancies.

Close to 85% stem cell therapy developers are based in North America and Asia-Pacific regionsWithin these regions, the US, China, South Korea and Japan, have emerged as key R&D hubs for stem cell therapies. It is worth noting that majority of the initiatives in this domain are driven by small / mid-sized companies

Over 1,500 grants were awarded for stem cell research, since 2015More than 45% of the total amount was awarded under the R01 mechanism (which supports research projects). The NCI, NHLBI, NICHD, NIDDK, NIGMS and OD emerged as key organizations that have offered financial support for time periods exceeding 25 years as well.

Outsourcing has become indispensable to R&D and manufacturing activity in this domainPresently, more than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing services to cater to the unmet needs of therapy developers. Examples include (in alphabetical order) Bio Elpida, Cell and Gene Therapy Catapult, Cell Tech Pharmed, GenCure, KBI Biopharma, Lonza, MEDINET, Nikon CeLL innovation, Roslin Cell Therapies, WuXi Advanced Therapies and YposKesi.

North America and Asia-Pacific markets are anticipated to capture over 80% share by 2030The stem cell therapies market is anticipated to witness an annualized growth rate of over 30% during the next decade. Interestingly, the market in China / broader Asia-Pacific region is anticipated to grow at a relatively faster rate.

To request a sample copy / brochure of this report, please visit this link

The USD 8.5 billion (by 2030) financial opportunity within the stem cell therapies market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom stem cell therapies are currently considered to be a promising alternatives for the treatment of a myriad of disease indications, with the potential to overcome challenges associated with conventional treatment options. The report includes detailed transcripts of discussions held with the following experts:

The research covers brief profiles of several companies (including those listed below); each profile features an overview of the company, financial information (if available), stem cell therapy portfolio and an informed future outlook.

For additional details, please visithttps://www.rootsanalysis.com/reports/view_document/stem-cells-market/296.html

or email [emailprotected]

You may also be interested in the following titles:

Contact:

Gaurav Chaudhary+1 (415) 800 3415+44 (122) 391 1091[emailprotected]

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Market Growth of Global Stem Cells to Remain Sluggish through 2020 2030 - The News Brok

Cardiac Stem Cells Comments Off on Market Growth of Global Stem Cells to Remain Sluggish through 2020 2030 – The News Brok | September 3rd, 2020

KENILWORTH, N.J.--(BUSINESS WIRE)--Sep 2, 2020--

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from its broad and diverse oncology development program will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from Sept. 1921. Data spanning more than 15 types of cancer will be presented at the congress, with new findings from Mercks portfolio of established medicines including KEYTRUDA, Mercks anti-PD-1 therapy; LENVIMA (lenvatinib, in collaboration with Eisai); and LYNPARZA (in collaboration with AstraZeneca). Pivotal Phase 3 data evaluating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal cancer from the KEYNOTE-590 trial (Abstract #LBA8) and LYNPARZA in patients with metastatic castration-resistant prostate cancer (mCRPC) from the PROfound trial (Abstract #610O) were selected for inclusion in ESMO Presidential Symposium sessions. Additionally, new findings will be shared for three of Mercks novel investigational candidates: vibostolimab (MK-7684), an anti-TIGIT antibody; MK-4830, an antibody targeting ILT4; and MK-6482, an oral HIF-2 inhibitor.

At Merck, we are focused on further improving long-term outcomes for more patients living with cancer, and this commitment is reflected in the breadth and diversity of our oncology research program, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. At the ESMO Virtual Congress 2020, we look forward to sharing important new results including survival data for KEYTRUDA in esophageal cancer and long-term findings in lung cancer, melanoma, and head and neck cancer, as well as research from our expansive pipeline.

Key data from Mercks portfolio and pipeline to be presented at ESMO include:

KEYTRUDA

KEYTRUDA Plus LENVIMA

LYNPARZA

Pipeline

Merck Investor Event

Merck will hold a virtual investor event in conjunction with the ESMO Virtual Congress 2020 on Tuesday, Sept. 22 from 89 a.m. E.T. Details will be provided at a date closer to the event at https://www.merck.com/investor-relations.

Details on Abstracts Listed Above and Additional Key Abstracts for Merck

KEYTRUDA

Classical Hodgkin Lymphoma

Colorectal Cancer

Diffuse Large B-Cell Lymphoma

Esophageal Cancer

Head and Neck Cancer

Lung Cancer

Melanoma

Sarcoma

Solid Tumors

KEYTRUDA Plus LENVIMA (in collaboration with Eisai)

Lung Cancer

Melanoma

Renal Cell Carcinoma

Solid Tumors

LYNPARZA (in collaboration with AstraZeneca)

Ovarian Cancer

Prostate Cancer

Vibostolimab

Lung Cancer

MK-4830

Solid Tumors

MK-6482

Von-Hippel Lindau Disease

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

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New Scientific Data at the ESMO Virtual Congress 2020 Reflect Merck's Commitment to Advancing Cancer Research and Care - The Baytown Sun

Cardiac Stem Cells Comments Off on New Scientific Data at the ESMO Virtual Congress 2020 Reflect Merck’s Commitment to Advancing Cancer Research and Care – The Baytown Sun | September 3rd, 2020

AMSBIO has announced new additions and certifications for its range of clinical grade, chemically defined cryopreservation excipient solutions STEM-CELLBANKER and HSC-BANKER.

STEM-CELLBANKER DMSO Free GMP grade is a new chemically defined freezing solution that does not contain DMSO as an anti-freezing agent. It was developed for customers who prefer not to use DMSO-containing cryopreservation solution due to the intended application of the samples. STEM-CELLBANKER DMSO Free GMP grade is manufactured in compliance with JPN, EU, US, and PIC/S GMP guidelines.

STEM-CELLBANKER is a chemically defined freezing media optimized for stem cells and iPS cells storage, as well as fragile primary cells. Published data supports its ability to cryopreserve organoids and tissues to allow the recovery of viable cells. STEM-CELLBANKER GMP grade is manufactured in compliance with JPN, EU, US, and PIC/S GMP guidelines. Free from animal derived components this popular cryopreservation medium contains only chemically defined USP, EP and JP grade ingredients. Available in both DMSO containing and DMSO-Free formulations, STEM-CELLBANKER is an optimal freezing solution for basic research and is finding widespread use in the clinical application of cell therapy products.

Manufactured to be completely free of serum and animal derived components, HSC-BANKER contains only European or US Pharmacopoeia graded ingredients making it suitable for storage of hematopoietic stem cells developed for cell therapy applications.

Recently the master files of HSC-BANKER were accepted by the Center for Biologics Evaluation and Research (CBER) within the US FDA (Food and Drug Administration). Master files are submissions to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. Beneficially they allow researchers to reference material without disclosing Master file contents to those parties.

HSC-BANKER is supplied ready-to-use and requires no special devices, such as a controlled rate freezer, in order to achieve consistently high viabilities following resuscitation from cryopreservation, even over extended long-term storage. HSC-BANKER significantly increases cell viability while maintaining cell pluripotency, normal karyotype and proliferation ability after freeze-thaw. Evaluated for endotoxins, pH, osmolarity and mycoplasma contaminants to ensure GMP equivalent quality. HSC-BANKER is part of the CELLBANKER range of cryopreservation media for cells, organoids and tissues.

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Optimized Freezing Solutions for Clinical Application of Cell Therapy Products - Technology Networks

IPS Cell Therapy Comments Off on Optimized Freezing Solutions for Clinical Application of Cell Therapy Products – Technology Networks | September 3rd, 2020

HACKENSACK, N.J., Sept. 1, 2020 /PRNewswire/ --Royal Biologics, an ortho-biologics company specializing in the research and advancement of autologous and live cellular solutions, today announced the completed acquisition of FIBRINET, from Vertical Spine LLC. The acquisition comes as part of Royal Biologics' strategic initiative to add novel technologies to its growing portfolio of autologous and live cellular solutions to support orthopedic and spinal fusion.

The FIBRINET system utilizes a patient's own autologous blood to create a platelet-rich fibrin matrix/membrane (PRFM). During this process, a patient's autologous platelets are harvested first through centrifugation and then combined with a proprietary solution to solidify into a fibrin clot/membrane. PRFM can be used to help augment spinal fusions and provide surgeons a new and novel biologic option. FIBRINET is the first commercialized system that utilizes a non-thrombin solution to create a reproducible platelet-rich fibrin matrix. The use of its proprietary solution to solidify a fibrin membrane provides the unique advantage of creating a biologic reservoir of growth factors and stem cells that can be held and used at the point of care for spinal fusion.

"We are extremely excited to add FIBRINET to our growing portfolio of autologous and live cellular therapies," says Salvatore Leo, Royal Biologics Chief Executive Officer. "FIBRINET'S technology now allows surgeons to harvest a patient's autologous cells and create a unique platelet-rich fibrin membrane-scaffold to be used at the point of care in most spinal fusion procedures. When added to our current product portfolio of autologous and live cellular therapies, we feel that providing each patient an opportunity to harvest their own unique cells for treatment is a superior option in many surgical settings."

FIBRINET has shown promising results and has been adopted into major orthopedic institutions in the United States. Hospitals such as Hospital for Special Surgery, Mount Sinai, NY Presbyterian and Connecticut's Orthopaedic Institute have all adopted FIBRINET into their spine services portfolio of approved products for use.

In a recent European Spine Journalstudy, at a one-year follow-up, FIBRINET demonstrated over a 92.4% radiographic fusion, and there was a significant improvement recorded in VAS scores for both back and leg pain. Compared to baseline figures, the number of patients using opioid analgesics at 12 months decreased by 38%. While the majority (31/50) of patients that participated in the study were retired, 68% of the employed patients were able to return to work.1

"FIBRINET presents itself as a low-cost option to obtain premium, high-quality viable cells from the patient for each fusion procedure," comments Dr. James Yue, Co-Chief and Orthopedic Spine Surgeon at Midstate Medical Center. "During this pandemic, a time when patients are having difficulty receiving operations in major hospital systems, the transition of procedures to ambulatory surgery centers has become even more desired and essential. FIBRINET's low-cost bundle provides surgeons the ability to offer a live viable cell product, point of care in a streamlined and safe environment for spinal fusion."

As part of a national re-launch plan for FIBRINET, Royal Biologics has just launched a new 3D animated moviethat demonstrates the unique features and benefits of FIBRINET's technology. "We wanted to show surgeons, distributors and our peers a new and creative take on Autologous & Live Cellular therapy," comments Leo. "With the recent pandemic and industry environment, we felt it was necessary to help create a unique viewing experience of the FIBRINET system."

FIBRINET comes after two other recent product launches from Royal Biologics in Q1 of 2020. Magnus, a live viable cellular allograft, and Cryo-Cord, a live cellular umbilical cord, were launched in the first quarter of 2020. Both products focus on providing live cellular therapies without the use of traditional toxic cyro-protectants. Both products are new, novel approaches to preserving live cells in a cryo-protected format.

Royal Biologic's FIBRINET is available for U.S. national distribution. Please contact [emailprotected] for more information.

1"Singlecenter, consecutive series study of the use of a novel plateletrich fibrin matrix (PRFM) and betatricalcium phosphate in posterolateral lumbar fusion," European Spine Journal https://doi.org/10.1007/s00586-018-5832-5, July 16, 2018.

SOURCE Royal Biologics

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Royal Biologics Announces the Acquisition of FIBRINET - PRNewswire

Spinal Cord Stem Cells Comments Off on Royal Biologics Announces the Acquisition of FIBRINET – PRNewswire | September 1st, 2020

The Plasma Therapy market research report added by Market Study Report, LLC, is an in-depth analysis of the latest trends persuading the business outlook. The report also offers a concise summary of statistics, market valuation, and profit forecast, along with elucidating paradigms of the evolving competitive environment and business strategies enforced by the behemoths of this industry.

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Plasma Therapy Market Overview with Detailed Analysis, Competitive landscape, Forecast to 2025 - StartupNG

Cardiac Stem Cells Comments Off on Plasma Therapy Market Overview with Detailed Analysis, Competitive landscape, Forecast to 2025 – StartupNG | September 1st, 2020