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Global Stem Cell Market Poised for Strong Growth as Global Regenerative Medicine Market Poised to Reach US$45 billion by 2025 – P&T Community

By daniellenierenberg

DUBLIN, Feb. 27, 2020 /PRNewswire/ -- The "Stem Cell Banking - Market Analysis, Trends, and Forecasts" report has been added to ResearchAndMarkets.com's offering.

The growing interest in regenerative medicine which involves replacing, engineering or regenerating human cells, tissues or organs, will drive market growth of stem cells. Developments in stem cells bioprocessing are important and will be a key factor that will influence and help regenerative medicine research move into real-world clinical use. The impact of regenerative medicine on healthcare will be comparable to the impact of antibiotics, vaccines, and monoclonal antibodies in current clinical care. With the global regenerative medicine market poised to reach over US$45 billion by 2025, demand for stem cells will witness robust growth.

Another emerging application area for stem cells is in drug testing in the pharmaceutical field. New drugs in development can be safely, accurately, and effectively be tested on stem cells before commencing tests on animal and human models. Among the various types of stem cells, umbilical cord stem cells are growing in popularity as they are easy and safe to extract. After birth blood from the umbilical cord is extracted without posing risk either to the mother or the child. As compared to embryonic and fetal stem cells which are saddled with safety and ethical issues, umbilical cord is recovered postnatally and is today an inexpensive and valuable source of multipotent stem cells. Until now discarded as waste material, umbilical cord blood is today acknowledged as a valuable source of blood stem cells. The huge gap between newborns and available cord blood banks reveals huge untapped opportunity for developing and establishing a more effective banking system for making this type of stem cells viable for commercial scale production and supply. Umbilical cord and placenta contain haematopoietic blood stem cells (HSCs). These are the only cells capable of producing immune system cells (red cells, white cells and platelet).

HSCs are valuable in the treatment of blood diseases and successful bone marrow transplants. Also, unlike bone marrow stem cells, umbilical cord blood has the advantage of having 'off-the-shelf' uses as it requires no human leukocyte antigen (HLA) tissue matching. Developments in stem cell preservation will remain crucial for successful stem cell banking. Among the preservation technologies, cryopreservation remains popular. Development of additives for protecting cells from the stresses of freezing and thawing will also be important for the future of the market. The United States and Europe represent large markets worldwide with a combined share of 60.5% of the market. China ranks as the fastest growing market with a CAGR of 10.8% over the analysis period supported by the large and growing network of umbilical cord blood banks in the country. The Chinese government has, over the years, systematically nurtured the growth of umbilical cord blood (UCB) banks under the 'Developmental and Reproductive Research Initiation' program launched in 2008. Several hybrid public-private partnerships and favorable governmental licensing policies today are responsible for the current growth in this market.

Competitors identified in this market include:

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/vgxw4q

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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SOURCE Research and Markets

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Global Stem Cell Market Poised for Strong Growth as Global Regenerative Medicine Market Poised to Reach US$45 billion by 2025 - P&T Community

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Carry-on item for Be the Match volunteers: Organ transplants – Minneapolis Star Tribune

By daniellenierenberg

The bag that Laurie Olesen gripped as she walked through the airport looked like any other carry-on. But the bright blue canvas tote would carry more than her cellphone, e-reader and toiletries. It would hold the last, best hope of survival for a desperately ill patient.

Bound for the East Coast, Olesen was on a mission to pick up blood stem cells or bone marrow provided by a donor, then fly with it to another city where it would be transfused into a recipient.

The product travels so the patient or the donor doesnt have to, said Olesen, 66, of St. Paul.

Olesen is a volunteer courier for Be The Match. Based in Minneapolis, the nonprofit registry serves people diagnosed with a variety of life-threatening blood, bone marrow or immune system disorders.

Shes one of a cadre of 400 of specially trained volunteers that form a crucial, reliable and affordable link between donors and patients.

These couriers are prepared to get a call, race to the airport and reach across time zones with a perishable product that comes with a true deadline. The consequences of a delay can be devastating even lethal for a patient waiting for the unique match.

Our volunteer couriers have to work on a tight time frame. They manage the paperwork and fill out a chain of custody form to document exactly where the cooler has been. We want it in a volunteers line of sight at all times, said Rut Kessel, volunteer specialist with Be The Match. They protect it with their life because it is a life.

Only about 30% of patients who need a bone marrow or blood stem cell transplant can find a donor within their family. Be The Match provides an international database of more than 20 million to locate an unrelated donor. When such a wide net is cast, the recipient and the anonymous donor rarely live in the same city. Theyre usually in different states, regions or even countries.

Thats where couriers come in.

Many volunteers are retirees who have time and flexibility. The gig also attracts firefighters, health care workers and airline employees whose shift work creates consistent open days in their schedules. While costs for their flights, hotels and other travel expenses are covered, couriers arent paid for their time.

They also never meet or even learn the names of donors or recipients. They typically pick up a numbered product at one lab and deliver it to another.

We have strict rules about confidentiality, explained Kessel. The courier experience is detached from the people involved. Something has gone terribly wrong if a courier ever meets or even sees a donor or recipient.

But many couriers have a personal connection to Be The Match.

Someone did this for me, said Lisa Maxson, 37, an Ohioan who was diagnosed with acute myeloid leukemia in 2011. Hospitalized for months while she had chemotherapy and radiation to kill her own diseased bone marrow, the mother of three underwent a transplant to replace it with healthy donor cells.

While I was sick, I decided I would give back to the organization that saved my life, she said.

Her family now sponsors a 5K race to benefit Be The Match. And this winter, she traveled to the registrys headquarters in the North Loop to take the two-day training for volunteer couriers.

Im so excited to be a courier for my transplant brothers and sisters, she said. I know what it feels like to be afraid youre going to die.

The gift of life

Every day of the year, volunteer couriers are in the air, crisscrossing the globe with the lifesaving cargo in temperature-controlled, medical coolers tucked under their seats. Last year, couriers living in 15 America cities made more than 2,600 trips, about a quarter of them to international destinations.

Five Minneapolis-based travel agents book their flights and manage their itineraries. Like the couriers themselves, the travel agents have to be nimble and act quickly when the unexpected occurs. Theyre also on call round-the-clock to rebook trips if mechanical difficulties cancel a flight or blizzards or hurricanes snag the travel grid, said Bonnie Bagley, who supervises the agents.

Two years ago, Bagley became a volunteer courier and now uses vacation time to make deliveries.

That closed the loop for me. Now I literally see how the system that Ive had a glimpse of works for patients, she said. I understand the passion our volunteers have. Theres an adrenaline rush when youre carrying the product.

For her part, Olesen likely holds the record for the most trips, which she estimates at a hundred deliveries to every region in the United States as well as a number of foreign countries.

Couriers have to be assertive, but must also remain calm, she said. You cant get rattled when things dont go as planned.

Shes also learned how best to deal with foreign customs agents.

When you bring a product from another country into the U.S., you have to declare the product to customs. You carry a special letter but, to tell the truth, some agents dont know what theyre supposed to do. Thats where the diplomacy comes in, said Olesen. You have to help them do their job without alienating or provoking them. You learn to kill them with kindness.

In 1986, Olesen was the first employee for the organization that became Be The Match. A registered nurse, she was working with blood collection at the American Red Cross in St. Paul when it was among a consortium of blood banks that received a grant to develop the nations first bone marrow registry. She was hired to identify donors for specific patients.

She joined the few lab technicians and transplant center employees who flew donations from donor to recipient. As the registry expanded and number of patients and donors increased, Be The Match added volunteer couriers in 2004. Olesen set up volunteer and education programs, managed search operations and kept up her courier duties.

While most of her deliveries have gone off without a hitch, shes had a few near-misses, including the time when a drop-off spot in Barcelona turned out to be a dead end. She and a cabdriver bridged their language gap to figure out the correct spot and hustle across the city.

We have guidelines for tipping, but that was one time I gave a little extra out of my own pocket, Olesen recalled. He went above and beyond.

And then there was the time when she had completed her pickup in London, only to arrive at the airport as a snowstorm shut it down.

I went to the gate agent and told them I was carrying bone marrow. They declared the flight a life flight and our plane was prioritized. We took off when the first runway opened, she said. When you do this, the courier gods are always on your side.

Although Olesen retired from Be The Match two years ago, she keeps her bag packed and her passport ready so she can continue to fly as a volunteer.

Being a courier reminds me of what were about. It affirms why we do what we do every day, she said. I know that within 24 hours after I get the product to its destination, it will be transfused into the recipient. That can give a person their life back.

Kevyn Burger is a Minneapolis based freelance broadcaster and writer.

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BioLineRx Announces Notice of Allowance from USPTO for Patent Covering Motixafortide (BL-8040) in Combination With Anti-PD-1 for the Treatment of Any…

By daniellenierenberg

TEL AVIV, Israel, Feb. 27, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX), (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent application claiming the use of motixafortide (BL-8040), a novel immunotherapy compound, combined with any PD-1 inhibitor, for the treatment of any type of cancer.

The PD-1 antagonist can be any agent that prevents and/or inhibits the biological function and/or expression of PD-1, such as pembrolizumab (KEYTRUDA). The targeted cancer can be solid, non-solid, and/or a cancer metastasis.

This patent, whenmedi issued, will be valid until July 2036 with a possibility of up to five years patent term extension. Additional corresponding patent applications are pending in Europe, Japan, China, Canada, Australia, India, Korea, Mexico, Brazil and Israel.

"We are extremely pleased to receive this valuable notice of allowance from the USPTO, which entitles us to long-term, highly enforceable and broad patent protection for our lead product, motixafortide, in combination with any PD-1 inhibitor, and more importantly, for all cancer indications, including, of course, any solid tumor," stated Philip Serlin, Chief Executive Officer of BioLineRx. "This important patent allowance also supports our ongoing Phase 2a COMBAT/KEYNOTE-202, for which we have recently completed patient recruitment in the triple combination arm investigating the safety, tolerability and efficacy of motixafortide, KEYTRUDA and chemotherapy. Following promising initial results demonstrating robust and durable responses to the triple combination treatment, we look forward to the progression-free and overall survival data from the triple combination arm expected in mid-2020."

The COMBAT/KEYNOTE-202 Study

The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multicenter, single-arm trial to evaluate the safety and efficacy of the dual combination of motixafortideand KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study was primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and was carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary.

In July 2018, the Company announced the expansion of its immuno-oncology collaboration with MSD to include the triple combination arm investigating the safety, tolerability and efficacy of motixafortide, KEYTRUDA and chemotherapy as part of the Phase 2a COMBAT/KEYNOTE-202 study. In January 2020, the Company announced completion of recruitment of the 40 patients planned for the triple combination arm of the study.

About Motixafortide in Cancer Immunotherapy

Motixafortideis targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

Motixafortideis a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, motixafortidehas been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

About BioLineRx

BioLineRx Ltd. (NASDAQ: BLRX), (TASE: BLRX) is a clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

The Company's lead program, motixafortide, is a cancer therapy platform currently being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with MSD. Motixafortideis also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.

BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook,Twitter, and LinkedIn.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2019. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contact:

Tim McCarthyLifeSci Advisors, LLC+1-212-915-2564tim@lifesciadvisors.com

or

Tsipi HaitovskyPublic Relations+972-52-598-9892tsipihai5@gmail.com

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SOURCE BioLineRx Ltd.

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Creative Medical Technology Holdings Inc (OTCMKTS: CELZD) Gets the Extra D – MicroCap Daily

By daniellenierenberg

Creative Medical Technology Holdings Inc (OTCMKTS: CELZD) is the new temporary ticker symbol for Creative Medical since the Company affected a 1 for 150 reverse stock split. According to the Company the reverse split of our stock was a decision that did not come lightly. In order to secure more competitive financing terms and to reduce existing convertible debt, the company needed to return to the OTCQB. As the fundamentals of the company continue to expand and commercialization is ramped up, this was determined to be necessary for the long-term benefit to the company and its shareholders. The reverse affected ALL shareholders, including founding shareholders, Officers and Directors, who have substantial holdings in CELZ stock as well said Timothy Warbington CEO.

Microcapdaily has been reporting on CELZ for years; on November 18, 2018 we stated: CELZ is an exciting stock that has attracted legions of shareholders who see big things happening here. CELZ flagship CaverStem has the only procedure to treat Erectile Dysfunction with adult stem cells in the US. CELZ has runner in its blood and a long history of huge moves skyrocketing from $0.002 in March of last year to highs topping $0.07 per share in August, CELZ loves to run and is a volume leader regularly among the top most traded on the OTCBB.

Creative Medical Technology Holdings Inc (OTCMKTS: CELZ)is a commercial-stage biotechnology company focused on Urology and Neurology using stem cell treatments. The companys team consists of leading international researchers in regenerative medicine with a science-first approach to treatments ensuring that all of its treatments are proven to be both safe and effective. CELZ is engaged in stem cell research and applications for use to treat male and female sexual dysfunction, infertility and related issues. It holds a patent for its erectile dysfunction (ED) treatment and was granted a license by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, a non-profit biomedical research and education institute (LABIOMED), for the infertility treatment. It has also filed a patent application focused on physical manifestations of female sexual arousal disorder, as an extension of the work with stem cell therapies for ED.

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Creative Medical is currently in the commercial stage of its bone marrow based stem cell treatment for Erectile Dysfunction known as CAVERSTEM, which is being marketed both nationally, and internationally. Earlier this year the Company formed the subsidiary CaverStem International LLC for the purpose of commercializing its erectile dysfunction technology to international physicians.

In a recent update on StemSpine Thomas Ichim PhD of CELZ stated StemSpine will surely be welcomed by the over 50 million Americans suffering from CLBP in the United States as a drug free alternative. Currently, there are minimal treatment options for patients that suffer from this debilitating pain, with roughly 50% of patients progressing to opioids and surgery. I have been thrilled with the positive reception of StemSpine across all fronts as we quietly progressed the program forward over the last few months, said Timothy Warbington, President and CEO of Creative Medical Technology Holdings, Inc. I am especially energized by the positive reception from potential healthcare providers who have overwhelmingly confirmed this is a necessary and highly desirable alternative to current treatment options. We look forward to partnering with these providers and bringing this therapy to the forefront in 2020 for the benefit of the many patients that stand to benefit from it and for our shareholders as we think it will drive tremendous value for the organization.

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Currently on the move since affecting a 1 for 150 reverse CELZ is fully reporting OTCBB, has minimal cash in the treasury, $3.9 million in current liabilities and some revenues reporting $169k in sales in 2019. we stated in 2016: CELZ is an exciting Company developing in small caps; CELZ flagship CaverStem has the only procedure to treat Erectile Dysfunction with adult stem cells in the US. The erectile dysfunction market is booming! According to a recent report from ResearchAndMarkets.com, the size of the global erectile dysfunction market is expected to reach $4.25 billion by 2023. CELZ loves to run and is a volume leader regularly among the top most traded on the OTCBB.We will be updating on CELZ when more details emerge so make sure you are subscribed to Microcapdaily so you know whats going on with CELZ.

Disclosure: we hold no position in CELZ either long or short and we have not been compensated for this article.

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Be a Bone Marrow Hero – University of Utah Health Care

By daniellenierenberg

Feb 25, 2020 12:00 AM

Every ten minutes, someone passes away from a blood disorder. Thats 148 people a day. There is a way to prevent many of these deathsa bone marrow transplant. DNA matching has the power to help thousands of people waiting for a life-saving bone marrow donation, but this special donor list depends entirely upon the willingness of individuals to sign up. Could your unique DNA hold the match that helps one person live to see tomorrow? Heres how you can find out.

Be The Match is a global hub for bone marrow donor registry working with hundreds of partners to support the transplant community. Signing up is easy online. You provide registration information, receive a kit in the mail, use the DNA swab as directed, and send it back for DNA typing. Your potentially life-saving information is secure and becomes available to specialized doctors around the world.

Even if you arent a match right away, the fact that every three minutes a person is diagnosed with a blood disorder means you could be called at any time to be a hero in someones time of need. Paloma Cariello, MD, MPH, says, Its absolutely a life-saving procedure. Its a new life that people getwe call it a new birthday, and at many hospitals they give it as a new birthday date in their chart. We sing Happy Birthday. Its a big event.

To find a close enough match to help fortify a patients immune system, doctors have to be precise. They first reach out to family, but even then, only 30% of patients find a good match. The odds of finding a match in an unrelated donor can be as low as 18%, especially with minorities.

The need for more individuals of every background cannot be overstated, says University of Utah Health Hematologist Sagar Patel, MD. He emphasizes the need for ethnic minorities to register. Every ethnicity is represented in the pool of patients, so the donor pool likewise needs to be diversified to improve the availability of similar DNA typing.

If a doctor finds you to be a suitable match, they select the ideal method for their patient and prepare you for donation. There are two donation methods: peripheral blood stem cell (PBSC) donation and bone marrow donation. Because every donor is carefully screened and prepared, and because a small amount of fluid is ultimately needed, neither procedure method impacts the performance of your own immune system, says Cariello.

With PBSC retrieval, you receive a stimulant for five days to increase the presence of blood-forming cells in your blood stream. Then a refined process of extraction occurs: Your blood is drawn, a machine collects just the cells the patient needs, and your remaining fluids are safely returned to you. This process can usually be done in one eight-hour session. Most donors report a full recovery within a week to 10 days, but you will be followed-up with until your full recovery.

If the doctor determines that the patient needs bone marrow, your procedure is a bit different. Marrow needs to be drawn from your pelvic bones. It happens in a hospital and under anesthesia, and you will feel no pain as the donation is collected. You can go back to routine activity the same day, and your system fully replenishes within four to six weeks.

Even with thousands of people in need, only about one in 430 donors in the Be The Match system are called in as a match. And the simple processes and expert professional care you receive minimize potential risk. A common side effect is bruising at the procedure sites, and some donors occasionally experience mild pain, fatigue, or dizziness. Reactions related to the use of anesthesia might also occur.

With such little risk, it shouldnt be a question as to whether you sign up, but when. And today is a perfect day. The low odds of finding a cure that these patients face are as extreme as the high rewards that await themand youwhen you make the choice to become a donor. Visit BeTheMatch.org to learn more and to become the one who initiates the miraculous call: We found a match.

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YOUR HEALTH: Knee relief can be found in the womb – WQAD.com

By daniellenierenberg

CHICAGO About 54 million Americans suffer from the aches and pains of arthritis.

Treatments range from pain medications to injections to surgery.

None of it seemed to work for 77-year-old Marty Ciesielczyk.

And it jeopardized something he loved: jogging.

"For me, it's just enjoyable, and if you're not a runner, then you would have no idea what I'm talking about."

But Marty's active lifestyle was in jeopardy when knee pain took over.

"When you got to lay on the floor to get dressed, it's tough."

It happens when there's a loss of cartilage in the joint.

"It's like a tire, and as you slowly lose rubber on the tire, it wears away," explained Dr. Adam Yanke, a surgeon with Midwest Orthopaedics at Rush University.

"You might need to have the tire replaced at some point."

Marty's arthritis was too advanced for a scope procedure but not bad enough for a joint replacement.

So he enrolled in a study testing whether amniotic fluid, which surrounds a growing baby in the uterus, could help his pain.

"Amniotic products come from patients that are having healthy, elective C-sections, and they choose to donate these products at the time of the delivery," said Dr. Yanke.

It's thought to increase tissue healing and lower inflammation.

Doctor-diagnosed arthritisis more common in womenthan in men. Arthritis and other joint disorders are among the five most costly conditions among adults 18 and older.

Your bone marrow makes mesenchymal stem cells, or MSCs. They are known to grow into new tissues, including cartilage.

By gathering these cells and injecting them into the knee joint, the hope is that they will give growth to new cartilage and reduce inflammation.

Marty received a placebo during the study, but then chose to have the amniotic fluid when the study ended.

"I mean I didn't care if it was Pixie dust, as long as my knee was going to feel better."

He went from not being able to get dressed to jogging about a week after having the injection.

"This morning, I ran three, three miles, and I had no problem at all."

Amniotic fluid is also being used to treat ulcers in the eye.

Rush University will be enrolling patients for a larger follow-up study on amniotic fluid for joint pain in the future.

Clinical trialsare still going on and most studies are still early.

A review published in 2016 in BMC Musculoskeletal Disorders concluded that MSC-based therapies offer an "exciting possibility" for treatment, but further studies need to be done on how they can best be used and how well they work.

They are also known to be very expensive.

If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens atjim.mertens@wqad.comor Marjorie Bekaert Thomas atmthomas@ivanhoe.com.

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Consistent Outcomes Using Ryoncil as First-Line Treatment or Salvage Therapy in 309 Children With Steroid-Refractory Acute GVHD – Yahoo Finance

By daniellenierenberg

NEW YORK, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that aggregated results from 309 children treated with Ryoncil (remestemcel-L) were presented atthe American Society for Transplantation Cellular Therapy and the Center for International Blood & Bone Marrow Transplant Research (TCT) meeting in Orlando, Florida on February 22. The data showed that treatment with RYONCIL across three separate trials resulted inconsistent treatment responses and survival outcomesinchildren with steroid-refractory acute graft versus host disease (SR-aGVHD).

Key findings and conclusions were:

Mesoblast Chief Medical Officer Dr Fred Grossman said: These aggregated data from three studies demonstrate consistent efficacy and safety of RYONCIL in children suffering from steroid refractory acute graft versus host disease. If approved, RYONCIL has the potential to be an effective and safe therapy to improve survival outcomes in the most vulnerable population of children with severe forms of this disease who can have mortality rates as high as 90 percent.

In January, Mesoblast filed a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for RYONCIL for the treatment of children with steroid-refractory aGVHD. The Company has requested Priority Review of the BLA by the FDA under the product candidates existing Fast Track designation. If approved, RYONCIL is expected to be launched in the US in 2020.

About Acute GVHDAcute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3. There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.

About Ryoncil Mesoblasts lead product candidate, RYONCIL, 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. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in SR- aGVHD 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.

References1. Niederwieser D, Baldomero H, Szer J. (2016) Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey.2. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology.3. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation.

About MesoblastMesoblast Limited (Nasdaq: MESO; ASX: MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platforms to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing process yields industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its rexlemestrocel product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Story continues

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Mesoblasts Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the timing, progress and results of Mesoblasts preclinical and clinical studies; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

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Cumberland County family turns to non-FDA approved stem cell treatment to help two-year-old son with cerebral palsy – FOX43.com

By daniellenierenberg

Lance was diagnosed with cerebral palsy a year ago. His family hopes non-FDA approved stem cell treatment for the disease can help him walk and talk.

CAMP HILL, Pa. A family in Cumberland County has turned to stem cells to treat their two-year-old son diagnosed with cerebral palsy. The only problem: stem cell treatment for the disease hasn't been approved by the FDA.

The day he was born, when he wheeled him down the hall and he was only a pound, and I started to cry and said, will he live? And he said, of course Hes only small," said Danielle Maxwell, Lance's mom.

The words, "he's only small," are what Lance's mom and father Rob have lived by since the day he was born. The preemie, born three months early, has been through several surgeries and complications along the way. But, Lance has always been a fighter.

Lance fought so hard just to survive the beginning of life, and come home with us," said Danielle. "And he is just so happy and loving and amazing.

About a year ago, Lance was diagnosed with cerebral palsy. Doctors told his family, he will never walk, talk or take care of himself.

We just dont believe that," said Danielle. "We dont.

Lance receives a lot of different therapies but, his parents did not want to just stop there.

We both overwhelmingly feel, he never gave up, he never gave up on us, he never gave up on himself," said Rob. "So, we owe it to him to give him the opportunity. Its really that simple, he deserves the opportunity."

Danielle began researching stem cell therapies, even speaking to doctors in countries overseas where treatment with stem cells is more readily accessible than in the U.S. The FDA has approved stem cell treatments for some conditions but not cerebral palsy. However, trials to determine the effectiveness of stem cell treatment for the disease are underway.

What weve seen is a small but real appearing improvement in motor function," said Doctor Charles Cox with University of Texas Health in Houston, began a trial in 2013 on the safety and effectiveness of banked cord blood or bone marrow stem cells in children with cerebral palsy, and is now just wrapping up the results from the trial.

The overall results of this study depend if youre a glass half full or half empty kind of person," said Dr. Cox. "It is not a compelling miraculous result. Its not, Oh my God, this child was treated and look at this profound benefit.'"

Because stem cell treatment for cerebral palsy is still in trial phases, it's not approved treatment by the FDA. However, the Maxwells did find a doctor in Harrisburg willing to transfer stem cells from a full-term baby's umbilical cord to Lance. But, since it isn't FDA approved, we were not allowed to be there to show Lance receiving the stem cells. The Maxwells are hopeful following this procedure Lance may someday walk and more importantly be able to communicate with them.

He wants to be involved," said Rob. "You can tell hes trying to communicate he just cant get over that hump. We believe stem cells could be that bridge to help him move a little faster.

Danielle says, it will take about six months to see if the stem cells will have any definitive benefits for Lance. But, already says she's seeing progress. She says Lance is not able to stand on his own.

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Stem Cell Therapy Market Scope and Opportunities Analysis 2017 2025 – Instant Tech News

By daniellenierenberg

Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

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Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Scientists May Have Found A Way To Boost The Body’s Ability To Heal Itself – IFLScience

By daniellenierenberg

Its not just Wolverine that has the ability to rebuild and restore wounded tissue. In fact, we all have a quite remarkable capacity to heal when we suffer an injury, thanks to our ability to produce new stem cells. Obviously, there is a limit to how much damage our bodies can repair, although researchers may have just discovered a way to enhance our powers of restoration by increasing the rate at which these stem cells are generated.

A new study in the journal Regenerative Medicine describes how scientists were able to stimulate the self-repair response of rats in order to rebuild broken spines. Healing similar injuries in humans is currently not possible, and the study authors are hopeful that their technique could one day help people recover from a range of previously untreatable injuries.

Rats in the study were given a cocktail of two drugs, one of which is normally administered during bone marrow transplants while the other is used for bladder control. This caused the rats bone marrow to produce an elevated number of mesenchymal stem cells, which are stem cells that can develop into bone tissue.

As a consequence, enhanced calcium binding was seen at the site of the rats spinal injuries, speeding up the formation of new bone and healing the wounds.

The figure on the right shows the level of healing with no treatment, while the figure on the left shows the effect of the two drugs in combination. The red coloring indicates calcium incorporating into the bone, which is associated with enhanced healing. Image: Imperial College London

We know that when bones break they will heal, and this requires the activation of stem cells in the bone, explained study co-author Sara Rankin in a statement. However, when the damage is severe, there are limits to what the body can do of its own accord.

We hope that by using these existing medications to mobilize stem cells, as we were able to do in rats in our new study, we could potentially call up extra numbers of these stem cells, in order to boost our bodies own ability to mend itself and accelerate the repair process.

Because the drugs involved are already widely used, the researchers are hopeful that human trials can proceed without the need for extensive safety testing. If these trials produce the same results as those seen in rats, then this treatment could help to not only repair spinal injuries, but to speed up the rate at which broken bones heal and even mend damaged tissues in other organs.

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Consistent Outcomes Using Ryoncil as First-Line Treatment or Salvage Therapy in 309 Children With Steroid-Refractory Acute GVHD – BioSpace

By daniellenierenberg

NEW YORK, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that aggregated results from 309 children treated with Ryoncil (remestemcel-L) were presented atthe American Society for Transplantation Cellular Therapy and the Center for International Blood & Bone Marrow Transplant Research (TCT) meeting in Orlando, Florida on February 22. The data showed that treatment with RYONCIL across three separate trials resulted inconsistent treatment responses and survival outcomesinchildren with steroid-refractory acute graft versus host disease (SR-aGVHD).

Key findings and conclusions were:

Mesoblast Chief Medical Officer Dr Fred Grossman said: These aggregated data from three studies demonstrate consistent efficacy and safety of RYONCIL in children suffering from steroid refractory acute graft versus host disease. If approved, RYONCIL has the potential to be an effective and safe therapy to improve survival outcomes in the most vulnerable population of children with severe forms of this disease who can have mortality rates as high as 90 percent.

In January, Mesoblast filed a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for RYONCIL for the treatment of children with steroid-refractory aGVHD. The Company has requested Priority Review of the BLA by the FDA under the product candidates existing Fast Track designation. If approved, RYONCIL is expected to be launched in the US in 2020.

About Acute GVHDAcute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3. There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.

About Ryoncil Mesoblasts lead product candidate, RYONCIL, 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. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in SR- aGVHD 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.

References1. Niederwieser D, Baldomero H, Szer J. (2016) Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey.2. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology.3. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation.

About MesoblastMesoblast Limited (Nasdaq: MESO; ASX: MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platforms to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing process yields industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its rexlemestrocel product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Mesoblasts Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the timing, progress and results of Mesoblasts preclinical and clinical studies; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

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New sickle cell disease treatments are helping people live longer and giving them a higher quality of life – PhillyVoice.com

By daniellenierenberg

Treatment for sickle cell disease has come a long way since the 1970s when the life expectancy of people living with it was less than 20 years.

People with sickle cell disease are not only living longer life expectancy is now 42 to 47 years of age but are enjoying a better quality of life, too.

"In the Philadelphia area, there has been great pediatric care for sickle cells disease and because of that people who have it are living very well," said Dr. Farzana Sayani, a hematologist at Penn Medicine.

Sayani is the director of a comprehensive sickle cell program focusing on adults living with the disease. Penn also has an active transition program for youth transitioning from a pediatric institution to adult care.

Sickle cell disease is an inherited red blood cell disorder that affects about 100,000 Americans.It is most often found in people of African or Hispanic descent.About 1 in 365 African-American babies are born with sickle cell disease, according to Sayani.

People who have the disease inherit an abnormal type of hemoglobin in their red blood cells, called Hemoglobin S, from both their mother and father.When only one parent has the hemoglobin S gene, a child will have the sickle cell trait, but usually does not develop the disease. But they may pass it on to their children.

Hemoglobin is the protein in the blood responsible for carrying oxygen to the rest of the body. Hemoglobin S causes red blood cells to become stiff and sickle-shaped. Instead of being round in shape, they look like crescent moons.

Sickle cells are sticky and can bind together, blocking the flow of blood and preventing oxygen from getting where it needs to go in the body. This causes sudden attacks of pain referred to as a pain crisis.

There are severaldifferent types of sickle cell disease.Hemoglobin SS, also known as sickle cell anemia, is the most common and most severe type of sickle cell disease.

Anemia occurs when red blood cells die at a rate faster than the body can replace them. Normal red blood cells generally live for 90 to 120 days. Sickled cells only live for 10 to 20 days. This shorter life-to-death cycle is harder for the body to sustain.

Another form,Hemoglobin SC, is not as severe as sickle cell anemia, but it can still cause significant complications, Sayani said.Other forms include Hemoglobin S0 thalassemia, Hemoglobin S+ thalassemia, Hemoglobin SD and Hemoglobin SE.

Sickle cell disease screening is a mandatory part of newborn screenings in Pennsylvania.

If the screening is positive, the family is informed and plugged into the health care system in order to receive the proper care.

If the disease is not diagnosed at birth, a blood test can confirm it at any age in which symptoms start to surface.

The severity of sickle cell disease can vary.

Each individual is affected differently, making it difficult to predict who will get what complications, Sayani said. That is why a comprehensive sickle cell program is so important.

Early signs include a yellowish tint to the skin or jaundice, fatigue and a painful swelling of the hands and feet.

"Young children with sickle cell disease may be tired, not eat very well and have delayed growth," Sayani said. "They may also develop anemia, be at greater risk of infection and start to experience pain crises."

Acute pain crises, also known as vaso-occlusive crises, can lead to long stays in the hospital to manage the crippling pain. Children with sickle cell disease also tend to experience delayed growth and puberty.

As a person with sickle cell disease grows older, the sickled red blood cells start to affect various organs, bones and joints.

This can lead to acute chest syndrome, which occurs when damaged lung tissues makes it difficult to breathe. Brain complications, including stroke, are possible.People with sickle cell disease are also prone to heart damage, eye problems, and infections like chlamydia, salmonella and staphylococcus. Chronic and acute pain is common.

There are different types of medicine that can help manage sickle cell disease.

Last year, an oral medicine was approved that makes sickle cells less likely to sickle. So was an intravenous medicine that has been shown to reduce pain crises and hospitalizations by 50%. Some people living with sickle cell disease also may need regular blood transfusions.

Hydroxyurea has also been used successfully for many years to reduce pain crises and the need for blood transfusions and hospitalizations.

Currently, blood and bone marrow transplant is the only way to cure the disease. But it is not an option for everyone because of the difficulty of finding a well-matched stem cell donor.

A related donor is best but only about a third of sickle cell patients have a donor that is related and fully-matched, Sayani said.

While these transplants have a 85% or more success rate, they also are associated with significant risks, including organ dysfunction, infection and graft vs. host disease which can be quite debilitating.

Transplants completed in children have the best results, Sayani said. But because of the risks involved, doctors only suggest it for patients with severe forms of the disease.

Early clinical trials with gene therapy are also showing promise, she added.

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Experimental study speeds up bone healing with 2 common medications – New Atlas

By daniellenierenberg

A new proof-of-concept study has found a combination of two drugs, already approved by the FDA for other uses, may boost the release of stem cells from bone marrow and accelerate the healing of broken bones. Only demonstrated in animals at this stage, the researchers suggest clinical trials could progress rapidly considering the drugs have already been demonstrated as safe in humans.

"The body repairs itself all the time, says corresponding author on the study Sara Rankin. We know that when bones break they will heal, and this requires the activation of stem cells in the bone. However, when the damage is severe, there are limits to what the body can do of its own accord.

A great deal of current research is focusing on mesenchymal stem cell (MSC) therapies. MSCs are a type of adult stem cell that can grow into a variety of different cell types including muscle, fat or bone. Many current MSC treatments in development involve extracting a small number from a patient, growing them in laboratory conditions, then injecting them back into the patient.

The new research set out to investigate whether any currently approved drugs can function to mobilize the bodys natural ability in releasing MSCs, with a view on speeding up healing of bone fractures. A study published in the journal npj Regenerative Medicine, describes the testing of two already approved drugs in a rodent spinal injury model.

The two drugs tested were an immunostimulant called Plerixafor, used to stimulate the release of stem cells from bone marrow in cancer patients, and a beta-3 adrenergic agonist developed to help bladder control.

The results suggest the duo of drugs mobilize MSCs into the bloodstream and speed up the process of bone formation and healing by enhancing the binding of calcium to the injury site. Tariq Fellous, first author on the new study, suggests the next step is to investigate whether this drug combination enhances blood MSC levels in human subjects.

We first need to see if these medications release the stem cells in healthy volunteers, before we can then test them in patients with fractures, says Fellous. We have the drugs and know they are safe to use in humans - we just need the funding for the human trials.

The researchers say prior studies have identified circulating MSCs increase in volume following injuries such as burns, bone fractures, and even heart attack. The hypothesis is that the release of MSCs is a physiological process aiding general regeneration following injury, and if circulating numbers of MSCs could be pharmacologically enhanced then a variety of types of tissue regeneration could be accelerated.

It is important to note the current study only examined increases in circulating MSCs and the rate of spine injury healing compared to no drug treatment. The current research offers no indication whether the drug duo influences nerve healing or restores movement.

So, more work is certainly necessary to understand how clinically useful these results actually are. However, as the studys co-first author Andia Redpath notes, this re-purposing of existing medicines to boost stem cell activity is an easier, cheaper, and more efficient way to enhance healing compared to other, more complex and time-consuming, stem cell treatments in development.

Rather than devising new stem cell treatments from scratch that involve lengthy and expensive trials, our approach harnesses the power of the bodys own stem cells, using existing drugs, says Redpath. We already know the treatments in our study are safe, its now just a matter of exploring further if they help our bodies heal.

The new study was published in the journal npj Regenerative Medicine.

Source: Imperial College London

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New hope for the healing of spinal column injuries with generally available drugs – The Washington Newsday

By daniellenierenberg

A combination of two commonly available drugs may help the body heal spinal fractures.

Scientists have discovered a combination of two commonly available drugs that could help the body heal spinal fractures.

The early-stage research in rats, by a group of scientists led by Imperial College London, revealed two existing medications can boost the bodys own repair machinery, by triggering the release of stem cells from the bone marrow.

The scientists published their research in the journalnpj Regenerative Medicine.

The team says the two drugs (currently used for bone marrow transplants and bladder control) could be used for different types of bone fractures, including to the spine, hip, and leg, to aid healing after surgery or fractures.

When a person has a disease or an injury, the bone marrow (the spongy tissue within bone) mobilizes different types of stem cells to help repair and regenerate tissue.

This image shows repair of the spine three weeks after surgery. The image on the left is with no drug treatment, with the image on the right (b3+AMD3100) showing the effect of the two drug treatments. The red colour indicates calcium incorporating into the bone, which is associated with enhanced healing. Credit: Imperial College London/Beaumont Health

The new research, involving scientists from Beaumont Health in the U.S, suggests it may be possible to boost the bodys ability to repair itself and speed repair, by using new drug combinations to put the bone marrow into a state of red alert and send specific kinds of stem cells into action.

In the new study, funded by Wellcome, the researchers used drugs to trigger the bone marrow of healthy rats to release mesenchymal stem cells, a type of adult stem cell that can turn into bone, and help repair bone fractures.

Professor Sara Rankin, corresponding author of the study from the National Heart and Lung Institute at Imperial College London, said: The body repairs itself all the time. We know that when bones break they will heal, and this requires the activation of stem cells in the bone. However, when the damage is severe, there are limits to what the body can do of its own accord. We hope that by using these existing medications to mobilize stem cells, as we were able to do in rats in our new study, we could potentially call up extra numbers of these stem cells, in order to boost our bodies own ability to mend itself and accelerate the repair process. Further down the line, our work could lead to new treatments to repair all types of bone fracture.

The two treatments used in the research were a CXCR4 antagonist, used for bone marrow transplants, and a beta-3 adrenergic agonist, that is used for bladder control.

The rats were given a single treatment with the two drugs, which triggered enhanced binding of calcium to the site of bone injury, speeding bone formation and healing.

The researchers stress they did not analyze restoration of movement in the bone, or repair to additional tissue such as nerves.

One of the drugs used in the study was found to trigger fat cells in the bone marrow to release endocannabinoids, which suggests they may have a role in mobilizing the stem cells and thereby promoting healing. However, the researchers add that phytocannabinoids (such as cannabis) would not have the same effect, as they act on the brain rather than the bone marrow.

The researchers say the drug combinations now need to be tested in humans.

Dr. Tariq Fellous, first author of the research from Imperials National Heart and Lung Institute (NHLI) said: We first need to see if these medications release the stem cells in healthy volunteers, before we can then test them in patients with fractures. We have the drugs and know they are safe to use in humans we just need the funding for the human trials.

Dr. Andia Redpath, co-first author from the NHLI, added that repurposing existing medications that help the body heal itself so called Regenerative Pharmacology could have great potential as an efficient and cost-effective approach for a range of diseases. Rather than devising new stem cell treatments from scratch that involve lengthy and expensive trials, our approach harnesses the power of the bodys own stem cells, using existing drugs. We already know the treatments in our study are safe, its now just a matter of exploring further if they help our bodies heal.

This work was funded by Wellcome. Further support was provided by the National Heart and Lung Institute Foundation and the Lumbar Spine Research Society.

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New hope for the healing of spinal column injuries with generally available drugs - The Washington Newsday

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Community give child a hero’s homecoming – Thehour.com

By daniellenierenberg

FLORENCE, Ala. (AP) Cole Kelley grinned widely and waved Saturday (Feb. 15) as his head kept swiveling from one direction to the other to take in the amazing view surrounding him.

Hundreds of family members, friends, Mars Hill School classmates and other members of the community lined both sides of the school's parking lot to welcome the 8-year-old home.

The Mars Hill student and his parents, John and Caroline Kelley, had been away from home for 15 months while he has battled a rare disease.

That included a 460-day stay at the National Institutes of Health facility in Bethesda, Maryland, which is one of the few facilities with experience treating the disease dada2, which is a deficiency of the adenosine deaminase 2 (ADA2) enzyme.

According to dada2.org, the disease causes "recurrent strokes, severe systemic inflammation, immune deficiency, and damage to many of the body's tissues and organs."

The community organized the homecoming parade, which included an escort from Florence's police and fire departments, as well as people dressed in superhero outfits.

Along with Cole's classmates, Mars Hill High School cheerleaders joined the crowd, as did the school's football players, who showed up in their jerseys. The long reception line spanned the length of the parking lot coming off Cox Creek Parkway.

The procession made two laps through the parking lot amid loud cheers and flowing tears from the congregation before the family, clearly emotional from the outpouring, drove home.

"It's been amazing," Cole's cousin, Sara Beth Searcy, said while wearing a "Best Day Ever" shirt she bought during a Disney World trip Cole and the family took before his long hospital stay.

"This whole community has supported us from the very beginning," she said. "We could not have gotten through this without this entire community wrapping their arms around us."

Cole classmate Rogan Willingham held a sign that read "God answered our prayers."

"He's prayed, I don't know how many times a day, for Cole," his mother, Ginger Willingham, said.

"I'm glad he's back," Rogan said, adding he looks forward to being able to "play with him and all kinds of stuff."

"I was praying for him a lot," he said.

There were numerous other signs with messages, such as "Sweet Home, Alabama," "Super Cole" and "Welcome home, Buddy."

Emily Stutts, a friend of the family who helped organized the welcome, and fellow member of Jackson Heights Church of Christ, said Cole has been sick since he was 2 months old.

He had a bone transplant at the National Institutes.

"He lived off of having blood transfusions because his body did not make red blood cells," Stutts said. "After a while that became risky because his body can't filter out all the iron. So a bone marrow transplant was the only answer."

He was enrolled in the "Be the Match" bone marrow registry and was a match with a young man from Australia, who had volunteered to join the registry.

"He was able to give the bone marrow and they flew it over to Maryland and did the transplant," Stutts said. "It didn't take initially, and Cole has had three stem-cell transplants, all from the one donation from the Australian man.

"The fact that he's coming home is a miracle, because he had some very, very scary times that they didn't think he would survive. He had zero immune until Christmas day. That day his immune response occurred."

She said John and Caroline often talk about the amazing support they have been receiving back home. A community spaghetti supper, T-shirt sales and a Christmas fundraising event are among methods supporters have used to provide financial assistance for the parents, who have not been able to work during their son's hospitalization.

"The people at the hospital there can't believe the support that they've been given from this community," Stutts said. "They told them they see people from all over the world, but they've never seen the outpouring of love like they saw for the Kelleys.

"They deserve it. They're such good people."

Florence company High Cotton Homes provided assistance in a major way, Stutts said.

"They had to have all new heating and air units and vents put in and a water purification system, all new flooring and all new duct work because of his immune system," she said. "High Cotton took that on, got donations and completely remodeled his room and made it so Cole would have his own bathroom to help with germ prevention."

Cole still is susceptible to sickness and will continue to have medical appointments, Stutts said.

"His liver was damaged from the transplant so he's going to go to Vanderbilt for them to check his liver," she said. "There's still things that need to be addressed, but as far as his bone marrow, that is doing OK."

Stutts said Cole's disease has not kept him down.

"He is full of life," she said. "He's a happy kid. Even though he's been sick, if you had seen him, you would have never know it. He's made a huge impact on the people at the National Institutes for Health because no child's been there that long. That became his family. They had a going-away party at one of the doctor's homes."

The emotions of Saturday's homecoming were obvious among the crowd, many of whom hugged one another and cried.

"The one thing I kept hearing from everybody is it was more emotional than they through it would be," said Ronnie Pannell, family minister at Jackson Heights. It's been a big show of love. Mars Hill loves Cole Kelley, there's no doubt about that.

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Leukemia: Cancer Of The Blood – Modern Ghana

By daniellenierenberg

DEFINITIONLeukemia is a Cancer of blood forming tissues including bone marrow and the lymphatic system.This type of cancer hinders the body's ability to fight infection, leukemia involves the white blood cells.

CAUSES OF LEUKEMIALeukemia can develop due to a problem with blood cell production.

Several factors have been identified which increase the risk of having the cancer:

A family history of leukemiaSmokingGenetic disorder such as Down syndromeExposure to chemicals such as benzeneExposure to high levels of radiationTYPES OF LEUKEMIALeukemia can be Acute or Chronic. In Acute leukemia, Cancer cell multiply quickly while in Chronic leukemia, the disease progresses slowly and early symptoms may be very mild.

Leukemia can also be classified according to types of cells which are myelogenous leukemia and lymphotic leukemia involving myeloid cells and lymphocytes respectively.

SYMPTOMS OF LEUKEMIAExcessive sweating most especially in the nightFatigue and weaknessUnintentional weight lossFever or chillsFrequent infectionsBleeding easily and bruising easilyEnlargement of the liver or spleenLEUKEMIA IN PREGNANCYLeukemia affects approximately 1 in 10000 pregnancies.Women with leukemia have non-specific symptoms and some of them could also be attributed to pregnancy.

The damage in the fetus is correlated with the time of exposition and the fetus is most vulnerable during organnogenesis phase, Although chemotherapy has effect in the fetus, there are reports of cases with successful pregnancy.

It is necessary to study the relation among chemotherapy, the leukemia and the fetus in long term studies where fetus has been exposed to chemotherapy agents and is reported with normal characteristics at birth.

ENZYMES DEFICIENT IN LEUKEMIABlast cells from 100 cases of Acute leukemia were evaluated for the presence of methylthioadenosine phosphorylase (MTAase), an enzyme important in polyamine metabolism.

Ten cases (10%) had undetectable levels of MTAase activity. A relatively high frequency (38%) of MTAase deficiency was seen in all of T-cell origin.

MTAase deficiency occurs in a wide variety of acute leukemia, that the lack of enzyme activity is specific in malignant cells. The absence of MTAase in some leukemia may be therapeutically exploitable.

TREATMENT OF LEUKEMIALeukemia is usually treated by a hematologist-oncologist. These are doctors who specialize in blood disorders and cancer.

The treatment depends on the type and stage of the cancer, the treatment includes the following:

Chemotherapy uses drugs to kill leukemia cells.Radiation therapy uses high energy radiation to damage leukemia cells and inhibit their growth.

Stem cell transplantation replaces diseased bone marrow with healthy bone marrow.

Biological or immune therapy uses treatments that help your immune system recognize and attack cancer cells.

Targeted therapy uses medication advantages of vulnerabilities in cancer cells.

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Adoption of Hematology Analyzer Reagent Market to Soar Across Top Countries in the Globe Forecast to 2015 to 2021 – Lake Shore Gazette

By daniellenierenberg

Hematology is the branch of medicine which deals with the study, diagnosis, and treatment of blood-related disorders. It diagnoses issues related to white blood cells, red blood cells, platelets, bone marrow, and lymph nodes. Hematology also deals with the liquid portion of blood known as plasma. Some blood-associated diseases are anemia, leukemia, myelofibrosis, blood transfusion, malignant lymphomas, and bone marrow stem cell transplantation. Hematology analyzers, coagulation analyzers, flow cytometers, and slide strainers are some of the hematologic instruments used to analyze blood and blood-related disorders. Hematology analyzers are highly specialized instruments used to count the number of white blood cells, red blood cells, and platelets.

Hematology analyzers are made up of multiple analytical modules with unique sample preparation processes. They assist in the diagnosis of various diseases, such as infections, anemia, viruses, diabetes, genetic problems, and cancer. It also regulates plasma drug level for both therapeutic and illicit drugs. Fully automated hematology analyzers and semi-automated analyzers are the two types of hematology analyzer available based on the type of automation. Fatigue, pale skin, and shortness of breath with exertion are some of the common symptoms of blood disorders. Clinical testing laboratories, hospitals, and research institutions are some of the users of hematology analyzers and reagents.

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Currently, North America dominates the global hematology analyzer & reagent market, followed by Europe. This is due to the regions high disposable income and increasing adoption of automated hematology instruments by diagnostics laboratories in these regions. Asia is expected to be the fastest growing market in the next five years. This is due to the developing healthcare infrastructure and increasing funding towards the development of hematology products in this region. Moreover, rising awareness about better healthcare and a large patient population base are also driving the growth of the hematology analyzer & reagent market in Asia.

Increasing adoption of automated hematology instruments, rising technological advancements, and integration of basic flow-cytometry techniques in modern hematology analyzers are some of the key factors driving the growth of the global hematology analyzer & reagent market. In addition, rising demand for high-throughput hematology analyzers and development of high-sensitivity point-of-care (POC) hematology testing are also fuelling the growth of the global hematology analyzer & reagent market. However, the high cost of hematology analyzers and intense competition among existing players are restraining the growth of the global hematology analyzers & reagent market. In addition, stringent and time-consuming regulatory policies for hematology instruments also impede the market growth.

Usage of microfluidics technology in hematology analyzers and introduction of digital imaging system in hematology laboratories could open up opportunities for new players in the global hematology analyzer & reagent market. In addition, increasing focus toward emerging markets, such as India and China, could also open up opportunities for new players in the global hematology analyzer & reagent market. Moreover, safety and quality of hematology analyzer could be a challenge for the growth of the global hematology analyzer & reagent market.

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Increasing instances of partnership among hematology instruments and consumables manufacturers is one of the recent trends in the global hematology analyzer & reagent market. The major companies operating in this market are

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Firefighter raise thousands within hours for one of their own – WKYT

By daniellenierenberg

LEXINGTON, Ky. (WKYT) - Firefighters in Lexington spent their Saturday morning supporting their own with a pancake breakfast raising money for a young woman with a rare disease.

Chris OBryan has worked as a firefighter in Kentucky for 23 years. This past summer his daughter began experiencing stomach pain. After months of testing, doctors diagnosed her PCH, a rare disease caused by a mutation in bone marrow stem cells.

Once other Lexington Firefighters heard about OBryans daughter, they decided to help however they can.

Its seven days that this came together, said firefighter William Tabor.

Tabor initiated the breakfast without ever meeting OBryan and his family before.

Both men say that goes to show the family community within the fire department. Within just more than an hour of beginning the breakfast at 8 Saturday, they raised $5,000.

The money thats raised here is twofold, started OBryan. Some of its for my daughter and some of its for a Louisville firefighter who was tragically killed in Saint Louis.

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Transplant for Szary Syndrome is Patient’s First Step in Returning to the Dance Floor – Dana-Farber Cancer Institute

By daniellenierenberg

The first time Bill Cronin Googled his own cancer diagnosis in 2016, his heart sank. He had Szary syndrome, a rare and aggressive form of cutaneous T-cell lymphoma and staring back at him were countless articles predicting a negative prognosis.

However, after receiving a stem-cell transplant at Dana-Farber/Brigham and Womens Cancer Center, Cronin is returning to the life he enjoyed before cancer.

Im at a place I never thought Id get to, Cronin says.

In 2015, Cronin, then 60, started feeling incredibly itchy and developed an accompanying rash. He went to his dermatologist, who diagnosed him with eczema and told him to return in five months. The rash continued to grow, however, and at the five month mark, Cronins dermatologist encouraged him to undergo further testing at Dana-Farber.

A blood test revealed that Cronins T-cells a type ofwhite blood cells that make up part of the immune system had becomecancerous. In the case of Szary syndrome, lymphoma cells will circulatethrough the blood stream and deposit in different areas of the skin. This willgenerally lead to a full-body rash and intense itchiness.

Cronin would need a stem cell transplant to combat the disease, but before he could receive one, his care team had to get him into remission. Patients who do not achieve remission prior to transplant have a high chance of relapsing.

When they first told me everything, I was really scared, says Cronin. But I knew I was in one of the best places in the world to figure out and treat this rare disease.

Cronins pre-transplant care was spearheaded by oncologists David Fisher, MD, and Nicole LeBoeuf, MD, MPH, clinical director of Cutaneous Oncology at Dana-Farber, with his transplant conducted by Corey Cutler, MD, MPH, medical director of the Adult Stem Cell Transplantation Program at Dana-Farber. Initially, Cronins disease was incredibly resistant; for nearly three years, mainstay drugs including steroids, monoclonal antibodies, and enzyme blockers all failed to put his disease into remission.

Ultimately, it would take a new drug, mogamulizumab (a type of immunotherapy that directly kills T-cells involved with Sezary Syndrome) to get Cronins disease into remission.

In May 2019, Cronin was cleared to undergo an allogeneic transplant, a type of transplant that uses a donors stem cells, in this case, Cronins brother. Since his transplant Cronin has remained in remission.

We had to use all of our big guns to get him totransplant, but Im pleased with where we are now, says Cutler.

I know the situation can always change, but it was great tobe able to share some good news with my family and friends, adds Cronin.

Patients like Cronin serve as a reminder of how stem cell transplants have improved and continue to impact patient outcomes, Dana-Farber experts note. Initially offered to only an incredibly small patient population when first performed at Dana-Farber in the 1970s, research advancements have, and continue to, broaden who is eligible for a transplant. In 2019, Dana-Farber/Brigham and Womens Cancer Center (DF/BWCC) surpassed 10,000 total adult transplants.

This milestone indicates our success as a program and our volume has allowed us to do the research to help move the field forward rather impressively, says Joseph Antin, MD, chief emeritus of Adult Stem Cell Transplantation at DF/BWCC.

In 1996, Dana-Farber Cancer Institute and Brigham and Womens Hospital merged their then separate transplant centers. By pooling together physical and intellectual resources, the new combined program was able to more than double the number of transplants each hospital could perform individually.

We always felt collaboration was better than competition, explains Robert Soiffer, MD, vice chair of Medical Oncology for Hematological Malignancies and chief of the Division of Hematologic Malignancies, who oversaw the merger with Antin. Each side could learn from the other, and that helped to catapult us into the leadership position we have today.

The Stem Cell Transplantation Program is also bolstered by the Connell and OReilly Families Cell Manipulation Core Facility (CMCF), which was established in 1996. The state-of-the-art center, led by Jerome Ritz, MD, not only processes the stem cells for transplant; it also assists researchers in developing new cell-based therapies for patients.

Another key component to the programs success has been the creation of the Ted and Eileen Pasquarello Tissue Bank. The Pasquarello Tissue Bank receives, processes, banks, and distributes research samplesof blood, bone marrow, and other tissues. Through a database overseen by Vincent Ho, MD, the Institute is able to log, assess, and later review every patients disease, including all complications and mutations. This technology allows researchers to explore the genetic makeup of past donors and better understand why a transplant was or was not successful.

Were still learning from biological specimens we collected 20 years ago, and it will continue to impact care 20 years from now, Soiffer says.

Today, there is a continuous push to develop new and more precise therapies to complement and improve stem cell transplants. The hope is to bring new treatment options to patients like Cronin who are facing rare and difficult diseases.

Before his diagnosis, Bill, and Barbara Finney, his partner ofnearly 30 years, were avid English Country dancers. English Country dancingevolved from the court dances of Europe in the early 17th century, and Croninand Barbara have friends from all over the country who share their passion forit.

While Cronin isnt dancing just yet, as hes stillrecovering from his transplant, he says he couldnt have gotten through thiswithout his partner on the dance floor and in life.

Barbara has been amazing and has helped take care ofeverything I couldnt do, he adds. Ive been fortunate and privileged to notonly have her, but to have been able to come to Dana-Farber.

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From Germany with love: Alfie, four, meets his stem cell saviour – Express

By daniellenierenberg

Alfie Commons and mum Lorna, 40, met Christin Bouvier, 34, for the first time on Wednesday after spending more than two years communicating via anonymous letters due to donation laws.

Alfie, from Toton, Notts, was diagnosed with acute lymphoblastic leukaemia (ALL) at seven months after he had a cold for six weeks.

After chemotherapy failed, Alfie was put on a trial immunotherapy drug which helped him to recover to be eligible for a stem cell transplant.

Unable to find a family match, his family found Christin on a worldwide register operated by blood cancer charity DKMS. She donated her cells in a one-hour op and they were flown to the UK and slowly passed into Alfies body in August 2016.

When the teacher, from Schwerin, Germany, was finally allowed to meet the family at Chiswick Town Hall in west London, the little boy gave a gift of Lacoste Pink perfume.

Mum-of-two Lorna, who works in HR, said: The meet-up was just amazing, it was everything we could have possibly dreamed of there were lots of hugs and tears.

It didnt feel like I was meeting her for the first time because wed been chatting for so long before.

As a family, we owe so much to Christin, words of thanks will never feel enough.

Christin just cried when she heard the recipient was a baby. She said: After I donated my bone marrow and the anaesthetic wore off, I called DKMS.

They told me that Alfie was a small baby and living in the UK but couldnt tell me any more due to the laws. When I found out Alfie was responding to treatment, so many tears of joy ran down my face. I still cant describe that moment.

Its a moment that is always with me. Whenever I feel a bit down, I think back to it as it always brings me so much happiness! She added that the meeting was so amazing. I was very nervous and shaking at first and when we finally met we cried a lot and hugged.

Alfie was shy at first but after a bit of time he became more comfortable and we played with some balloons and had a slice of cake.

After the transplant, Alfie developed a deadly immune condition, but this was controlled by medication. He was given the cancer all-clear in 2017 and has started school.

Lorna added: I just want more people to sign up to become donors theres a match for everyone.

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