SAN CARLOS, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- BioCardia, Inc.[NASDAQ: BCDA], a leader in the development of autologous and allogenic cell therapies, today reported financial results and business highlights for the third quarter of 2020 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2020 with the Securities and Exchange Commission on November 10, 2020.

The Company is advancing its autologous and allogenic bone marrow-derived cell therapies for three cardiovascular indications and one respiratory indication.

Third Quarter 2020 Business Highlights:

Autologous Cell Therapies

Allogenic Cell Therapies

Corporate Developments

We are reaching critical milestones in our cardiovascular and respiratory cell therapy development programs at a time when patients are increasingly presenting with heart damage due to COVID-19, said BioCardia CEO Peter Altman, PhD. We believe that the clinical data supports patient benefit through paracrine mechanisms, which differs from those attempting to transform cells into new heart cells, and believe that the approach has tremendous promise to help patients suffering from severe heart and respiratory diseases.

Third Quarter 2020 Financial Results:

Anticipated Upcoming Milestones in Q4 2020:

About BioCardiaBioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Companys biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information, visit http://www.BioCardia.com.

Forward Looking StatementsThis press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment of our clinical trials, the availability of data from our clinical trials, filings with the FDA, FDA product clearances, the efficacy and safety of our products and therapies, anticipated milestones, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardias business and product development plans and overall market conditions.We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control.Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent development of our therapeutic candidates.These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate.Additional factors that could materially affect actual results can be found in our documents filed with the SEC, including our recent filings on Form 8-K, Form 10-K and Form 10-Q, particularly any statements under the caption entitled Risk Factors Therein. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Media Contact:Michelle McAdam, Chronic Communications, Inc.michelle@chronic-comm.com(310) 902-1274

Investor Contact:David McClung, Chief Financial OfficerInvestors@BioCardia.com(650) 226-0120

BIOCARDIA, INC.Condensed Statements of Operations(Unaudited In thousands, except share and per share amounts)

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BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights - GlobeNewswire

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DetailsCategory: Small MoleculesPublished on Monday, 09 November 2020 08:56Hits: 725

Calquence demonstrated superior progression-free survival and favourable tolerability in both previously untreated and relapsed or refractory patients

LONDON, UK I November 9, 2020 I AstraZenecas Calquence (acalabrutinib), a next-generation selective Brutons tyrosine kinase (BTK) inhibitor, has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.

The approval by the European Commission was based on positive results from two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL.1,2 This follows a recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July 2020.

Paolo Ghia, MD, Director, Strategic Research Program on CLL, Universit Vita-Salute San Raffaele in Milan, and investigator of the ASCEND Phase III trial, said: One of our biggest hurdles in treating chronic lymphocytic leukaemia is finding tolerable treatment options that manage the disease long term, which typically impacts older patients with comorbidities. Todays news marks great progress for patients in Europe, as the Phase III clinical trials for Calquence showed a significant improvement in comparison with current standard treatments.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: This approval represents a key development for patients in Europe who until now have had limited chemotherapy-free treatment options. As our first European approval in blood cancers, Calquence provides a new tolerable treatment option with uncompromised efficacy and the potential to positively impact the quality of life for thousands of patients living with chronic lymphocytic leukaemia.

In the ELEVATE-TN Phase III trial, Calquence combined with obinutuzumab and as monotherapy reduced the risk of disease progression or death by 90% and 80%, respectively, compared with standard chemo-immunotherapy treatment chlorambucil plus obinutuzumab, in patients with previously untreated CLL.1 In the ASCEND Phase III trial, 88% of patients with relapsed or refractory CLL taking Calquence remained alive and free from disease progression after 12 months compared with 68% of patients on rituximab combined with idelalisib or bendamustine.2 Data from the interim results of the trials were published in The Lancet and Journal of Clinical Oncology, respectively.

Calquence is approved for the treatment of CLL and small lymphocytic lymphoma in the US and is approved for CLL in several other countries worldwide. Calquence is also approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in the US and several other countries. Calquence is not currently approved for the treatment of MCL in Europe.

As part of a broad development programme, Calquence is being assessed in more than 20 AstraZeneca-sponsored clinical trials for the treatment of patients with B-cell malignancies including CLL, MCL, diffuse large B-cell lymphoma (DLBCL), Waldenstrms macroglobulinaemia (WM), follicular lymphoma (FL), and other haematologic malignancies.

Chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in adults, with an estimated 105,000 new cases globally in 2016, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.3,4,5,6 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets. This could result in anaemia, infection, and bleeding.4 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

ELEVATE-TN

ELEVATE-TN (ACE-CL-007) was a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. Patients 65 years of age or older, or between 18 and 65 years of age with a total Cumulative Illness Rating Scale >6 or creatinine clearance of 30 to 69mL/min, were enrolled. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg approximately every 12 hours until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg approximately every 12 hours until disease progression or unacceptable toxicity).1

The primary endpoint was progression-free survival (PFS) in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint was IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints included objective response rate, time to next treatment and overall survival (OS).1

ASCEND

ASCEND (ACE-CL-309) was a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in patients with relapsed or refractory CLL. In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received investigators choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3K inhibitor, or rituximab in combination with bendamustine, a chemotherapy.2

The primary endpoint was PFS assessed by an IRC, and key secondary endpoints included physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as OS, patient-reported outcomes and time to next treatment.2

Calquence

Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. Calquence binds covalently to BTK, thereby inhibiting its activity.7,8 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.7

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, DLBCL, WM, FL, and other haematologic malignancies.

AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Companys haematology franchise includes two medicines approved by the US Food and Drug Administration and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZenecas haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio ofnew medicines that has the potential to transform patients lives and the Companys future. With seven new medicines launched between 2014 and 2020, and a broad pipelineof small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and haematology.

By harnessing the power of six scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visitastrazeneca.comand follow the Company on Twitter@AstraZeneca.

References

1. Sharman JP, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Blood. 2019; 134 (Supplement_1): 31. doi:10.1182/blood-2019-128404.

2. Ghia P, et al. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia [published online ahead of print, 2020 May 27]. J Clin Oncol. 2020; JCO1903355. doi:10.1200/JCO.19.03355.

3. American Cancer Society. What is Chronic Lymphocytic Leukemia? Available at https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html. Accessed August 2020.

4. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)Patient Version. Available at https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed August 2020.

5. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016. JAMA Oncol. 2018;4(11):1553-1568.

6. Jain N, et al. Prevalence and Economic Burden of Chronic Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies. Blood. 2015;126:871.

7. Calquence (acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.

8. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).

SOURCE: AstraZeneca

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Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia | Small Molecules | News Channels - PipelineReview.com

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A TEENAGE Jehovah's Witness was ordered to undergo a lifesaving blood transfusion after a concerned judge quashed her religious objection.

Doctors received the go-ahead to urgently give the 15-year-old blood when she was just hours from death.

3

The teen suffers from sickle cell, an inherited condition that affects red blood cells.

It puts her at greater risk of suffering a debilitating stroke - or dying.

At the High Court on Tuesday, November 10, Sir James Munby said the girl's life was in imminent danger, so he had rushed to make his decision, reports the Daily Mail.

He explained: "The blood transfusion is imperatively needed and within a timescale measured in hours, and not days.

"At one point, her doctor lamented that four hours had gone by because of the judicial proceedings."

Sir James described the patient as "wise beyond her years".

The unnamed teen has recently been baptised as a Jehovah's Witness, and has "profound religious beliefs".

Although Jehovah's Witnesses do not accept blood transfusions or blood products, based on biblical readings, he warned failure to help her presented a "very real risk" of "serious harm to her future health and welfare".

He acknowledged that the girl may end up refusing blood transfusions when older, and has more say on her medical treatment.

3

Sir James suggested that legal precedents dating back three decades needed to be re-examined for cases like this.

These previous decisions state that kids shouldn't have a say in whether or not they accept medical treatment.

In just three years time, when she reaches the age of 18, the girl will be legally able to reject such lifesaving help.

However, Sir James recommended the High Court to look at whether she should have more say on treatments - including blood transfusions - before she turns 18.

A 1970s ruling says Jehovah's Witnesses' beliefs must be given the same respect as those of other religions when it comes to kids' rights to reject treatment.

Appeal Court decisions in the 1990s stress that courts must decide what is in the best interests of under-16s, the Mail writes.

Teens aged 16 and 17 are allowed to have a say in their treatment - but this can be overruled in exceptional cases.

What is Sickle Cell?

Sickle cell disease (SCD) is a serious and lifelong health condition.

Sickle cell disease is the name for a group of inherited health conditions that affect the red blood cells.

The most serious type is called sickle cell anaemia.

People with sickle cell disease produce unusually shaped red blood cells.

These can cause problems because they do not live as long as healthy blood cells and can block blood vessels.

People with SCD start to have signs of the disease during the first year of life, usually around five months of age.

Symptoms and complications of SCD are different for each person and can range from mild to severe.

The only cure for SCD is bone marrow or stem cell transplant.

Sickle cell disease varies between individuals from mild to serious, but most people with it lead happy and normal lives.

But the illness can be serious enough to have a significant effect on a person's life, says the NHS.

It can lead to health problems like strokes, serious infections and lung problems, which can occasionally be fatal.

3

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Global Mesenchymal Stem Cells market report 2020 offers extremely oblique professional analysis and forecast from 2020 to 2026. The report also consists of market shares, size, profit revenue, and the Mesenchymal Stem Cells markets economic process. It also covers the strategic identification of major players within the market and analyzing their core competencies and methodology. The Mesenchymal Stem Cells market report analyzes information collected and integrated through recent analysis techniques and from trustful sources across varied industries.

A thorough evaluation of the restrains encompassed in the Mesenchymal Stem Cells report reveals the difference to drivers and contributes room for strategic planning. Features that overshadow the Mesenchymal Stem Cells market development are essential. They can be understood to devise different bends for getting hold of the profitable prospects present in the ever-growing market. Additionally, perceptions by market expert opinions have been taken to understand the Mesenchymal Stem Cells market better.

[Due to the pandemic, we have included a special section on the Impact of COVID 19 on the market which would mention How the Covid-19 is Affecting the Global Mesenchymal Stem Cells Market]

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Top Key Players of Mesenchymal Stem Cells Market:

(Celprogen Inc., Axol Bioscience Ltd., Stemedica Cell Technologies Inc., Cell Applications Inc., Stem cell technologies Inc., Cytori Therapeutics Inc., Cyagen Biosciences Inc., BrainStorm Cell Therapeutics.)

On the basis of Types, the Mesenchymal Stem Cells market:

Bone Marrow Umbilical Cord Blood Peripheral Blood Lung Tissue Synovial Tissues Amniotic Fluids Adipose Tissues

On the basis of Applications, the Mesenchymal Stem Cells market:

Injuries Drug Discovery Cardiovascular Infraction Others

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Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2016-2026) of the following regions are including,

The Research aims of the Mesenchymal Stem Cells Market report would be:

Major TOC points

1Mesenchymal Stem Cells Market Overview

1.1 Product Overview and Scope of Mesenchymal Stem Cells

1.2 Segment by Type

1.2.1 Global Sales Growth Rate Comparison by Type (2021-2026)

1.2.2 Type 1

1.2.3 Type 2

1.3 Segment by Application

1.3.1 Sales Comparison by Application: 2020 VS 2026

1.3.2 Application 1

1.3.3 Application 2

1.4 Global Market Size Estimates and Forecasts

1.4.1 Global Revenue 2016-2026

1.4.2 Global Sales 2016-2026

1.4.3 Mesenchymal Stem Cells Market Size by Region: 2020 Versus 2026

2 Global Mesenchymal Stem Cells Market Competition by Manufacturers

2.1 Global Sales Market Share by Manufacturers (2016-2020)

2.2 Global Revenue Share by Manufacturers (2016-2020)

2.3 Global Average Price by Manufacturers (2016-2020)

2.4 ManufacturersMesenchymal Stem Cells Manufacturing Sites, Area Served, Product Type

2.5 Market Competitive Situation and Trends

2.5.1 Mesenchymal Stem Cells Market Concentration Rate

2.5.2 Global Top 5 and Top 10 Players Market Share by Revenue

2.5.3 Market Share by Company Type (Tier 1, Tier 2, and Tier 3)

2.6 Manufacturers Mergers and Acquisitions, Expansion Plans

2.7 Primary Interviews with KeyMesenchymal Stem Cells Players (Opinion Leaders)

3 Mesenchymal Stem Cells Retrospective Market Scenario by Region

3.1 Global Mesenchymal Stem Cells Retrospective Market Scenario in Sales by Region: 2016-2020

3.2 Global Mesenchymal Stem Cells Retrospective Market Scenario in Revenue by Region: 2016-2020

3.3 North America Market Facts and Figures by Country

3.4 EuropeMesenchymal Stem Cells Facts and Figures by Country

3.5 Asia Pacific Market Facts and Figures by Region

3.6 Latin America Market Facts and Figures by Country

3.7 the Middle East and Africa Market Facts and Figures by Country

4 Global Mesenchymal Stem Cells Historic Market Analysis by Type

4.1 Global Sales Market Share by Type (2016-2020)

4.2 Global Revenue Market Share by Type (2016-2020)

4.3 Global Price Market Share by Type (2016-2020)

4.4 Global Market Share by Price Tier (2016-2020)

5 GlobalMesenchymal Stem Cells Historic Market Analysis by Application

5.1 Global Sales Market Share by Application (2016-2020)

5.2 Global Revenue Market Share by Application (2016-2020)

5.3 Global Price by Application (2016-2020)

..Countinued

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Mesenchymal Stem Cells Market to Witness Significant Rise in Revenue and Covid-19 Impact by 2026 | Celprogen Inc., Axol Bioscience Ltd., Stemedica...

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David Shaw walks into the hospital room and takes a seat next to the bed. He does this nearly every day, right around lunchtime.

He looks at his younger brother, Eric, tubes snaking across his arms, machines beeping and whirring. Eric does not look like Eric anymore, his skin darkened, scars deepened, features altered. They both know this but never mention it.

Eric is dying, a rare, aggressive skin cancer rampaging through his body with such ferocity that his doctors are nearly out of options. Radiation failed. Chemotherapy failed. Two bone marrow transplants failed.

As Stanford's head football coach, David Shaw is relied on to always know what to say, how to say it and when to say it; but he cannot find the words now that he and his brother are staring down what seems to be an inevitable fate.

"What do you say, where you think you've pulled at the last thread and there are no more threads?" David said. "All I could tell him was that I loved him and that I was there for him. The rest of it was really just ... I thought it was only a matter of time before he passed away."

Two years later, what happened between David and Eric remains real, present and raw -- changing their entire relationship, redefining what it means to be a brother. The words are still difficult to say, so they tip-toe around the crushing physical and mental toll Eric's cancer took on them.

David and Eric are sure to think about it all this weekend, when Stanford opens its season at Oregon on Saturday. Because the last time the Cardinal visited Eugene, neither one knew whether Eric would live or die.

After Stanford came from behind to win that game 38-31 in overtime, David delivered a message at the end of his postgame television interview, looking at the camera and saying, "To my brotherEric: I love you." He tapped the lime green pin on his black Stanford sweatshirt before he left the screen.

When Shaw became head coach at Stanford in 2011, it was the culmination of a family journey. His father was a longtime coach there; David played receiver for the Cardinal and eventually returned as an assistant under Jim Harbaugh. The entire Shaw family -- parents Willie and Gay, along with David, Eric and their sister, Tawnya -- all call the Bay Area home.

To this day, David says the day he was introduced as coach was "one of the better days in all our lives."

Yet something started to happen to Eric that no one could quite figure out. That same year, Eric found strange looking spots on his torso. His wife, Crystal, noticed the first one under his arm. Maybe it was eczema, they thought. Then the spots started to spread. He went to the doctor. They prescribed an ointment, but the spots kept popping up, until they covered his entire body. Eventually, tumors started to grow. It looked as if someone had pushed marbles under his skin. Doctors remained confounded. Eric itched uncontrollably, insatiably. His skin itched so badly, it became difficult to put on clothes, shower, sleep and go to work. He eventually needed sleep medication so he could get uninterrupted rest.

Even then, he itched subconsciously, only realizing what happened when he woke up in the morning to find his arms and sheets covered in blood. Some nights, he tried to sleep on his forearms so his body wouldn't touch the sheets, because his skin grew too sensitive to any touch. At one point, he had more than 30 open wounds on his body.

"It's something that's so pervasive and so destructive that a lot of people have mental problems -- you can't do anything without extreme pain," Eric said. "You bleed a lot through the tumors, through the lesions, through the scratching. A lot of people don't survive, really, because of the mental stress that comes with it."

Doctors had a hard time diagnosing his disease because it is often confused with psoriasis, eczema or other skin conditions. Eventually, they determined he had a rare form of skin cancer called mycosis fungoides, a type of T-cell lymphoma that affects one in 6 million people in the United States and Europe. At the time, Eric Shaw was 38.

In 2013, he and Crystal pushed for a referral to Stanford Cancer Center, which has leading experts in the disease. Mycosis fungoides is so rare, it accounts for only 4% of all non-Hodgkin lymphoma cases; among those who suffer from it, only 20% have the type of itching Eric experienced. Rarer still is to find it in people under the age of 40, and African American men often end up with the worst prognosis. All the odds were firmly against him.

"When you first hear skin cancer, your mind doesn't go too far," David said. "So initially I was like, 'There are creams and other minor surgeries. I think it'll be OK.' And then Eric said, 'No, this is not the typical skin cancer. This is inside my body. This is inside the layers of my skin, and it's not one spot. It's everywhere.'

"I didn't really get it for weeks after that because, rectifying something that I didn't think was so serious to [then thinking] ... 'Oh my gosh. So this is really cancer. This is really scary now.' It took a long time for that to sink in."

David turned it over in his mind. He was the big brother, the protector, the one who always made sure Eric would be OK. They were supposed to raise their kids together, grow old together, and reminisce about the randomness of a life spent together.

He kept coming back to one thought: You're not supposed to lose your little brother.

David and Eric Shaw grew particularly close as children as they moved from place to place when their father, Willie, took new coaching jobs. Tawnya, their older sister, fit in anywhere socially. But David and Eric, who is two years younger, stuck together.

"Like a pair," David said.

They loved riding their bikes and, when they moved to Arizona, they took advantage of the wide-open spaces in the new development where they lived. They rode for miles and miles, setting up their own ramps and doing tricks and wheelies, visiting friends along the way before returning home after dark. They played sports, too, and though David loved football as much as their dad, the basketball court is where the brothers had their epic battles.

"I was always kind of a little bit stronger and I'll never forget the last time we played one-on-one basketball," David said. "He just got better than me, and he won, and once I got over the anger and disappointment, I was proud because my younger brother had grown and was gaining confidence."

Said Eric: "I wanted nothing more than to beat him, and he wanted nothing more than to keep beating me. But, during those times, it was just us, it was me and him. He was my best friend."

David went on to play at Stanford and eventually got into coaching, against his mother's best wishes. Eric did not pursue a career in athletics. He went to San Diego State and got into a career in marketing at a financial services company, where his gregarious nature, big smile and easy laugh made him a perfect fit. Though their personalities are different -- David is stoic and introspective, Eric makes anyone feel as if they have been friends forever -- they are grounded in the same values they learned at a young age: family and faith above everything else.

Those principles only grew stronger after they found themselves in the Bay Area as adults.

After David was hired by Stanford, the entire Shaw family made it clear it would always be around to support him. Family members all have a standing invitation to come for dinner on Tuesdays. And they always attend home football games, waving and hugging David during the team's pregame walk, cheering from the stands, and then waiting for some time together once the game ends.

Even as Eric grew sick, he made it a point to go cheer for his big brother. "It's not just the football game. Our family comes together," he said. "We celebrate, we come to watch the game and cheer the team on and support David. And then afterwards, win or lose, we all wait for him to come out. It's a family day. It's been wonderful to share that experience with David."

Stanford eventually drew them even closer, and it had nothing to do with football.

Eric did not understand the gravity of his situation until his first meeting in 2013 with the doctors at Stanford Cancer Center. They put it bluntly: He had such an aggressive form of the disease that he needed immediate treatment. They would start with total skin radiation, preparing Eric to lose his hair, eyebrows, eyelashes, fingernails and toenails.

If that did not work, they would try chemotherapy next.

"All these thoughts are running through your mind," Crystal said. "'Is he going to make it? Is it going to work? What's going to happen?' At the time, our youngest daughter was 3 months old, so it was pretty overwhelming. We were just putting our lives together and then boom: you're in the middle of this cancer war."

The next week, Eric took a leave of absence from work and began four-times-a-week trips from their home east of Palo Alto, California, to Stanford Hospital, often driving as many as three hours one way in traffic. When he arrived, he went into a box and his whole body was exposed to the radiation light for about an hour. Then, he would make the drive back home to see Crystal and their four kids -- Caleb Michael, Jared Spann-Shaw, Madison Shaw and Olivia Shaw.

The radiation charred his skin. He lost weight. When he looked in the mirror, Eric no longer recognized the man looking back at him.

"Nothing prepares you for something like this," he said. "Knowing that other people were looking at me and knowing that something was very wrong, that was a daily grind to get myself up out of bed and get ready for the day, knowing that that was going to be my life."

He did this for three straight months, all to keep the disease from growing to a point where it would kill him. It worked for a short time, but the disease came back more aggressively six months later. Doctors moved on to chemotherapy treatments, some of them experimental, but also began discussing the last-resort option: a bone marrow transplant.

David and Tawnya immediately volunteered to become donors, and underwent testing. In most cases, siblings are the best chance at a donor match. Unfortunately, in their case, neither was close. On a 10-point match scale, Tawnya registered a 3, David a 5. Neither qualified to donate.

"I wanted to jump to the front of the line and say, 'Whatever I have to do, whatever you have to take out of me, however you have to do it, just do it,'" David said. "For them to come back and say that you're not a strong enough match was disheartening. It hurt me. The fact that we had to put our trust and faith in people that we didn't know, and that we're going to have to go out to registries and try to find someone who was a better match than I was, that uncertainty, and that doubt, it's hard to keep it at bay at that point. It starts to creep in."

Doctors eventually found two donors whom they believed could work, but they were not perfect matches. In early 2018, Eric and his family moved into a two-bedroom apartment near Stanford Hospital to prepare for the transplant. For three months, he went through radiation, then chemotherapy to prepare his body to accept the donor cells.

He underwent the transplant in April, feeling confident and inspired it would work. After a month, doctors did an initial check to see how many of the donor cells had survived the transplant.

None survived.

"It was like I never even had the transplant," Eric said. "That was so devastating. We just knew it was going to work. I mean, we're people of faith, and we knew everybody was praying for us, and that we were praying that this six-year journey was going to finally be over. And it wasn't over. It was crushing for them to say, 'It didn't work. We're going to have to try again.'"

The second attempt happened in September. Crystal bought lime green pins for the family to wear for lymphoma awareness. Without telling Eric or Crystal, David decided he would wear his on his shirt for the 2018 football season. In addition to that, he had lime green and yellow ribbons placed on the back of Stanford helmets as a way to show support for both cancer patients and cancer survivors.

He told his team that his brother was fighting cancer, and briefly mentioned the helmet ribbons publicly during an early-season news conference. But beyond that, David kept the severity of what was happening to his brother to himself, masking his growing nervousness, fear and anxiety as the clock ticked toward the next transplant. He had a hard time processing what was happening. He did not want to put that at the feet of his players, or his staff.

The doctors used the same donor cells that failed the first time for the second transplant on Sept. 11, 2018, because that was the only option available. But this time, doctors used even stronger drugs to prepare Eric's body to receive the donor cells -- hoping that would do enough to stop his immune system from attacking them.

When Stanford played Oregon on Sept. 22, no one in the Shaw family knew whether the transplant had worked. But the situation was more dire than the first transplant. The stronger chemotherapy caused major complications, and Eric became severely ill.

David coached the game with this in the back of his mind. Stanford rallied from a 21-7 deficit to win an overtime thriller, moving to 4-0 on the season, with a top-10 matchup against Notre Dame the following week. Back in Palo Alto, Eric watched the entire game alone in an apartment he rented near the hospital, the comeback buoying his spirits.

He had no idea his brother would speak to him through the television until he heard the words, "To my brother Eric ..."

"In that moment, I didn't feel any sickness at all," Eric said. "I can't really describe what I felt, just how proud I am of him and how awesome it made me feel that he would do that for me."

Said David: "If that transplant didn't work, I didn't know how many more games he was going to be able to see. That was an opportunity for me on national TV to speak to him, to say to my brother that against the odds, we came back and throughout the entire game, I was thinking about him."

Eric soon returned to Stanford Hospital. The chemotherapy destroyed his blood system, so he needed daily blood transfusions to stay alive. It came as no surprise when doctors told him the second transplant had failed. They had no plan now, no other donor options. David came by to visit as often as he could, but he had a hard time finding the words to say to his dying brother.

"I thought about Crystal. I thought about their kids," Shaw said. "I thought about, 'How can we help?' And then I kept going, 'We just can't get there. There has to be something else.' And we all prayed and we all comforted each other and trusted the doctors and prayed for the doctors. And just kept saying, 'Just tell us whatever options there are. Just tell us what to do and we'll do it.'"

During the day, Eric had his mother, Crystal, David, or David's wife, Kori, at his side, helping to keep his mind off what was happening to him. But in the evenings, when he was alone in his hospital room, he couldn't help but think about the dwindling medical options and his own death, slowly accepting what he believed would inevitably come.

Over seven years, everything the doctors tried had failed, and the disease always came back more aggressively. He felt exhausted in every possible way, desperate to feel better. He didn't want to die. All he wanted to do was get better, and see his kids again, hug his wife and go home. But that possibility seemed as far off as the stars.

"The doctors couldn't help us," Eric said. "They had lost all hope. There was nothing left, but we were in the deepest part of the valley, and there was nobody there but God. I said, 'You're going to take me off this Earth.' And he told me, 'Eric, you're not going to die.' That was the point at which my faith really took over, and I really had true peace."

His team of doctors huddled together again and came up with a plan many of their colleagues questioned, simply because they had never attempted it. In mid-October of 2018, they told Eric they wanted to try a third transplant.

Only this time, they wanted David to be the donor and they had only weeks to make it happen.

Eric thought, "Are they trying to kill me?"

When David was initially rejected, doctors had worked for 25 years to find a way to do half-match transplants but had virtually no success. By 2018, doctors explained that a different way to do the transplant had emerged, opening up the potential to try it with Eric. These transplants, called haploidentical transplants, typically use donor cells from a family member.

Dr. Wen-Kai Weng, Eric's bone marrow transplant physician, explained, "It was relatively new at this time. We decided to go ahead, because we knew if we didn't do it, the disease would really come back with a vengeance."

No one had ever done a third transplant with donor cells at Stanford.

"If he didn't go for this risk, he wouldn't be here," said Dr. Youn Kim, who treated Eric and heads Stanford's multidisciplinary Cutaneous Lymphoma Clinic/Program. "He wouldn't be living."

Doctors told Shaw there was a 15% chance he would not survive the transplant itself. If he did survive it, there was only about a 30% to 40% chance the donor cells would work. Compared to much steeper survival odds with no transplant at all, the decision -- filled with multiple layers of danger -- did not feel risky at all.

They had to try.

"They might have told us what the odds were, and I honestly just pushed it out of my brain," David said. "If this is the Hail Mary, hey, we're going to drop back and throw it as far as we can and send prayers along with it and hope that it works."

Without hesitation, David said to his brother, "Tell me what I need to do."

Stanford gathered in its team hotel early on Oct. 27 to begin final preparations before hosting Washington State later that day. David checked in for a 9 a.m. meeting and when it finished, he checked out of the hotel without saying a word. He walked toward the back exit, careful to make sure no one saw him, and snuck out the door to a waiting car.

Shaw sat in the passenger seat, headed toward campus and Stanford Hospital, praying all the while that what he was about to do would work.

He arrived at the hospital and was hooked up to an IV for the first dose of medication. This would not be the more traditional bone marrow transplant, where cells are extracted with a needle through the hips. Rather, the medication flowing through the IV would stimulate his body to overproduce the stem cells needed for the transplant, flooding his blood with them. The cells would then be extracted from his blood, and transplanted into Eric.

Doctors told him to expect to start feeling joint pain and tiredness within 24 hours. Those symptoms would grow only stronger over the coming days, when he came in for more medication. They told him he should stay off his feet, rest and remain hydrated.

That would be nice, David thought. But he had a game to coach. Only two people inside the program knew he had gone that morning: assistant athletic director for football operations Callie Dale, who drove him to the hospital, and defensive coordinator Lance Anderson.

"The way that I do my job, I work really hard not to make it about me," David said. "Although I wanted my team to know what my family was going through, college football is about the student-athletes. I wanted them to focus on what they needed to do. I didn't want to pull from that. I didn't want to, all of a sudden, now make it about me and my family."

A few hours later, he returned to the team hotel and acted as if he had been there the entire day, speaking nothing about his trip to the hospital. Shaw put on his lime green pin and made his way toward the bus. The short ride to the stadium felt long that day. His mind wandered before returning to the flip card in front of him.

As he exited the bus and finished the walk to the stadium, his two young nieces ran up to him. They squeezed him, holding on longer than usual, as if they knew their Uncle David was their only option, too.

He worried players would notice him moving around so slowly. If they did, no one said a word. Shaw kept pushing the pain aside, shoving his emotions down deep, saying prayers every chance he got.

On Wednesday, Shaw woke up and was so lethargic, he felt as if he was moving like a sloth. He went to the hospital for the final procedure: extracting the cells from his blood. Shaw wore comfortable clothes, arranged his pillows and settled in for a long day ahead. Doctors hooked him up to a machine that would do the work through two IVs: One took his blood so the needed donor cells could be siphoned out; the other IV would put the blood back in his body.

Eric rested on another floor in the same hospital.

David worked on his game plan, watched a few movies and occasionally stared at his own blood in the IVs, willing it to save his brother. He kept saying to himself over and over again, "God, I hope this works."

After eight hours, he was finished. Shaw then went out to practice.

"I remember walking up to him and just asking him, 'How are you doing, how are you feeling?'" Anderson said. "I could see it in him that he wasn't his normal self. He paused for a little bit and then he's like, 'I'm OK. A little bit tired, but I'm OK.' You know, just trying to put the most positive light that he could on it."

The next day, Nov. 1, 2018, Shaw went back to the hospital. It was transplant day, and he had to be with Eric to witness what they hoped would be a miracle. David and Crystal watched as Eric received a transfusion of David's stem cells, a shimmering light pink fluid flowing into his body. They sang and prayed. Already, they had received one small bit of good news: Doctors extracted 28 million cells from David's blood, about 20 million more than what they had hoped to get.

Stanford traveled the following day to Seattle, for a game against Washington. David felt guilty for leaving, but he knew there was nothing else he could do. Eric struggled in the hospital, not only from the transplant, but from the heavy chemo and radiation doctors used to prepare his body for the new cells.

Eric ran a fever of 105 degrees and vomited for days. The pain grew so intense he was put on a morphine drip and was in and out of consciousness. In Seattle, Shaw remembers being locked into the game, "except for those little moments where my heart was with my brother."

Stanford lost another heartbreaker, 27-23.

"I know us losing had nothing to do with everything David was going through," Dale said. "But just piling that on with everything else he was dealing with, it was a lot for him. He brought that up many times, about how Eric would tell him the biggest excitement for him every week was watching us play and watching us win. I know David had a lot of pressure on himself, amongst the pressure he already has as a head coach, to win for Eric. And I know that every time he did, he really felt like it was for him. And when we came up short, I know he was probably even harder on himself than he normally would have been."

Back at Stanford, David visited Eric when he could. But the waiting game took an increasing mental toll. David prides himself on his ability to compartmentalize, to focus on the only thing in front of him. He never spaces out, and he rarely gets emotional. But Shaw was falling apart on the inside.

He often found himself staring at cut-ups of red zone plays, not realizing the film had been paused for 20 minutes while his mind drifted off. Whenever that happened, he would stop and call someone, either his brother, his wife, his mother or Crystal just to see how they were doing.

"There were times where I thought life was slow motion, but it was actually moving and I was the one who was in slow motion," David said. "I found myself sometimes saying, 'Is this real? Is this really happening? This shouldn't happen.'"

In the middle of every single meeting, in the middle of every single film session, he silently prayed, "God help my brother. Just please let this one work."

"I look back now and I know more of everything that was going on and the situation," Anderson said. "I realized how much he was dealing with and how much he had to bear that week. And it's amazing that he was able to go through that week without really letting any of us really know exactly what he was going through and what a big deal this really was."

Within a few weeks, Eric started to turn a corner. Though they did not know whether the transplant had worked just yet, he showed enough improvement to leave the hospital after 52 days. David arrived for the big day, and Eric slowly put on a protective mask before shuffling to a waiting wheelchair. Doctors, nurses and support staff lined the hallway, clapping and cheering.

David cries when recalling that moment, his pent-up emotions flooding out as he describes it publicly for the first time.

"This is my little brother, after years of cancer, getting to leave the hospital," Shaw said, his voice quavering. He pauses to wipe tears from his eyes. "The nurses were crying. The doctors were crying. Because a few months earlier, they were preparing us for him to die. And he got to go home."

Three days later, doctors met with Eric and Crystal to deliver the results from the transplant. After only 27 days, Eric had none of his own blood coursing through his body.

It was all David's.

Eric picked up the phone.

"Dave," Eric said. "You have a twin. We're truly blood brothers."

Eric, who turns 46 on Friday, has lived a fairly normal life since he was declared cancer free on Jan. 1, 2019, although the coronavirus pandemic has limited how often the Shaw family can see each other.

In September, they decided to get together to celebrate all of their recent birthdays at David's house. They stayed outdoors, socially distanced, with masks on. Eric and David allowed themselves a hug, their heads turned to the side.

"Every time I see him, I just smile, you know? Because he gets to be here," David said.

Link:
'We're truly blood brothers': Stanford coach David Shaw and his recent fight to save his brother, Eric - KGO-TV

Bone Marrow Stem Cells Comments Off on ‘We’re truly blood brothers’: Stanford coach David Shaw and his recent fight to save his brother, Eric – KGO-TV | November 5th, 2020

The ' Stem Cell Banking market' research report now available with Market Study Report, LLC, is a compilation of pivotal insights pertaining to market size, competitive spectrum, geographical outlook, contender share, and consumption trends of this industry. The report also highlights the key drivers and challenges influencing the revenue graph of this vertical along with strategies adopted by distinguished players to enhance their footprints in the Stem Cell Banking market.

The latest research report on the Stem Cell Banking market assesses the major factors influencing industry growth with respect to the competitive dynamics and geographical reach. It also ensembles the challenges prevalent in this industry vertical and identifies opportunities that will further aid business expansion. Further, the report revisits all areas of the business to cover the impact of COVID-19 pandemic so as to assist stakeholders in devising new strategies and reinforcing their position in the market.

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Latest Study explores the Stem Cell Banking Market Witness Highest Growth in nea - GroundAlerts.com

Bone Marrow Stem Cells Comments Off on Latest Study explores the Stem Cell Banking Market Witness Highest Growth in nea – GroundAlerts.com | November 5th, 2020

MUSC Hollings Cancer Center researchers identified that blocking an alternative energy pathway for T-cells after hematopoietic stem cell transplant helps reduce graft-versus-host disease (GVHD) in an animal model of leukemia.

Xue-Zhong Yu, M.D., who also is associate director of Basic Science at Hollings, and collaborators at the Indiana University School of Medicine discovered that donor T-cells must have the key enzyme lysosomal acid lipase in order to induce GVHD.

The Yu laboratory focuses on understanding the biological balance between GVHD and graft-versus-leukemia effect. Hematopoietic stem cell transplantation is used as a treatment option for some leukemia patients. T-cells in stem cell grafts from a donor are given to a leukemia patient in order to kill the cancer and reboot the patient's immune system. GVHD is a big clinical challenge because the donor T-cells, which come from the bone marrow, can attack the patient's organs. Anywhere from 30% to 70% of patients develop acute GVHD after allogeneic bone marrow transplant and 15% die.

"When we deal with hematopoietic cell transplant, it is an important balance - blocking GVHD while still allowing T-cells to do their job and control the cancer," Yu said.

Each cell in our body has its own metabolic process. Cells convert the food that is eaten into energy in order to perform their intended functions. However, cellular metabolism is often altered in various diseases. Yu researches T-cell metabolism in order to understand the balance between graft-versus-host and graft-versus-leukemia responses.

Most cells in our body require oxygen to create energy efficiently. However, this research focused on lipid, or fat, metabolism. T-cells have special metabolic processes: Sometimes they multiply so rapidly that they need an extra source of energy from free fatty acids.

Lysosomal acid lipase is an enzyme that breaks the large lipids and cholesterol into individual free fatty acid building blocks. If that enzyme is missing, there are not enough free fatty acids for energy production. This changes the T-cell metabolism, which in turn changes T-cell function.

Clinically, broad spectrum immunosuppression drugs (steroids and rapamycin) are still used as the first line of care in patients with severe GVHD. However, Yu and collaborators hypothesized that changing T-cell metabolism could reduce GVHD after hematopoietic stem cell transplantation.

"We know that the gut is the primary organ affected by GVHD. Since the gut has less oxygen, the T-cells rely on free fatty acids and must use lysosomal acid lipase. We thought if we could remove or block the activity of that, we could reduce GVHD in the gut."

The Yu Laboratory collaborated with the Indiana University School of Medicine and used a lysosomal acid lipase-deficient mouse model. T-cells lacking lysosomal acid lipase were given to mice with leukemia. As a control, T-cells with lysosomal acid lipase from normal mice were given to another group of leukemia mice. Strikingly, the mice that received the T-cells without lysosomal acid lipase did not get severe GVHD. Additionally, the T-cells from the donor lysosomal acid lipase-deficient bone marrow still killed the leukemia cells.

To increase the clinical translational potential of the work, orlistat, the FDA-approved lysosomal acid lipase inhibitor was also tested in the leukemia model. Mice with leukemia were treated with orlistat every other day after receiving bone marrow from normal mouse donors. Similar to the first experiment with the lysosomal acid lipase-deficient bone marrow, blocking the activity of lysosomal acid lipase with orlistat greatly reduced GVHD while the graft-versus-leukemia effect was preserved.

Additionally, the researchers discovered that inhibiting the lysosomal acid lipase enzyme with orlistat reduced the number of pathogenic T-cells and increased the number of regulatory T-cells. The pathogenic T-cells are the ones that cause GVHD. Regulatory T-cells are one of the "braking mechanisms" of the immune system. They help to reduce the activity of the pathogenic T-cells and prevent GVHD damage.

Therefore, blocking lysosomal acid lipase activity with orlistat preferentially stopped the donor T-cells from damaging the gut but allowed the T-cells to function during circulation and kill the leukemia cells.

The researchers' future plan is to look deeper at the biological mechanisms. For example, it is not clear how the loss or inhibition of lysosomal acid lipase affects the other metabolites in T-cells. To move this finding closer to the clinic, Yu explained that human cells can be used in a special mouse model that recreates the human immune environment.

"Looking at the immune cells in the gut was technically challenging. However, the results were exciting because our hypothesis was validated. These results encourage us to continue studying this in order to provide better treatment options to patients."

Read the original post:
Blocking energy pathway reduces GVHD while retaining anti-cancer effects of T-cells - Science Codex

Bone Marrow Stem Cells Comments Off on Blocking energy pathway reduces GVHD while retaining anti-cancer effects of T-cells – Science Codex | November 5th, 2020

Taipei, Nov. 5 (CNA) An Indonesian migrant worker who received a stem cell transplant in Taiwan in June thanked the nation on Thursday for expediting her treatment by lifting travel restrictions for her family amid COVID-19 thereby facilitating the operation that saved her life.

At a press conference that day to celebrate being discharged from the hospital, 23-year-old Nina Herlina thanked Taiwan for giving her a new lease of life and said her treatment was a testament to Taiwan's healthcare capabilities. In November last year, Nina began suffering from bouts of menorrhagia that lasted for about 20 days and came with symptoms that included dizziness, tiredness, and fever.

In February, she turned to the Taiwan International Workers' Association (TIWA), a local NGO that promotes migrant workers' rights when she was fired, shortly after a doctor diagnosed her as suffering from aplastic anemia, an autoimmune disease in which the bone marrow stops making new blood cells. With the help of the TIWA, the young woman was allowed to remain in Taiwan, where she had worked as a caregiver since October 2018.

In March, she was confirmed as having severe aplastic anemia, requiring an allogeneic stem cell transplant to treat the disease, according to the TIWA. However, at that time the COVID-19 pandemic was worsening and Nina's family were in rural Indonesia and local medical institutions lacked the technology and techniques to identify a donor in time for a bone marrow transplant.

At that time she was being kept alive in Taiwan by weekly blood transfusions. However, frequent blood transfusions can have a detrimental effect on the success of a transplant.

In addition, she also had leukopenia, a condition when a person has a reduced number of white blood cells, which increases the risk of infection. As a result, doctors at Taipei Veterans General Hospital (TVGH) determined the patient was in urgent need of a transplant, according to TIWA.

With the assistance of TIWA, a TVGH medical team explained the condition to Herlina and her family members in Indonesia via video calls. Doctors said the healthy cells for the transplant should ideally come from a family member, making her two younger sisters, aged 5 and 14, the best candidates for the operation, TIWA said.

Based on humanitarian considerations, the Central Epidemic Command Center decided in June to lift travel restrictions for her mother and sisters to visit Taiwan.

After undergoing special blood tests arranged by TVGH, the 5-year-old sister was identified as a suitable donor for a transplant. The operation was carried out after the three family members completed their 21-day quarantine in Taiwan and provided two consecutive negative COVID-19 test results.

After having received medical treatment in Taiwan for nine months, Nina was discharged from the hospital Thursday, after doctors confirmed she had recovered from the life-threatening illness.

Read more here:
Critically ill Indonesian woman thanks Taiwan for saving life - Taiwan News

Bone Marrow Stem Cells Comments Off on Critically ill Indonesian woman thanks Taiwan for saving life – Taiwan News | November 5th, 2020

Several drugs that work by targeting genetic alterations in cancer cells have won recent approval from the Food and Drug Administration as treatments for patients with diffuse large B-cell lymphoma (DLBCL).

Dr. Germame Ajebo, assistant professor of medicine at Georgia Cancer Center at Augusta University, shared information on novel treatments for the disease during the recent virtual CURE Educated Patient Leukemia & Lymphoma Summit.

In his talk, Ajebo focused on drugs meant for use in disease that has recurred or become resistant to previous treatments.

DLBCL is a usually aggressive form of the blood cancer known as a B-cell non-Hodgkin lymphoma, which affects the immune system. The disease causes rapid growth of tumors in the lymph nodes, spleen, liver, bone marrow or other organs.

Approved by the FDA within the last two years to treat aggressive DLBCL are oral Xpovio (selinexor), Polivy (polatuzumab vedotin-piiq) and Monjuvi (tafasitamab-cxix). In addition, an immunotherapy, the chimeric antigen receptor (CAR)-T cell therapy Yescarta (axi-cel), was approved to treat the disease in 2017, Ajebo reported.

Read more: Monjuvi-Revlimid Combination Approval Fills Unmet Need for Certain Patients with DLBCL.

Xpovio is a nuclear export inhibitor, which prevents cancerous cells from pushing tumor-suppressing proteins out of their nuclei. This results in tumor suppressors accumulating in the nucleus, where they can work to kill the cell.

In the phase 2b clinical trial that led to its approval which administered Xpovio by itself to 134 previously treated older adult patients the partial response rate (including those with tumor shrinkage) was 16%, the complete response rate (including those with no sign of cancer remaining) was 13% and the rate of stable disease (including patients with no progression of cancer) was 8.2%, Ajebo reported. Looking at all patients who had partial or complete responses, 38% responded for at least six months and 15% for at least 12 months.

The most common side effects that were serious or worse were low blood counts, Ajebo summarized. Other serious side effects included nausea, vomiting, diarrhea, weight loss, dizziness and infections.

Polivy is an antibody-drug conjugate that uses a targeted drug to deliver a potent chemotherapy directly to cancer cells.

It was approved based on the results of a phase 2 study of 80 previously treated patients who were divided into equally sized groups to receive the chemotherapy Treanda (bendamustine) and the targeted drug Rituxan (rituximab) with or without Polivy every 21 days for six cycles. At the end of treatment, 40% of those receiving the triplet combination had experienced a complete response, compared with 18% of those receiving Treanda and Rituxan alone. In the 63% of patients who achieved a best overall response at any point in the study while receiving the drug triplet, 48% had a response that lasted at least 12 months and 64% responded for at least six months, Ajebo noted.

Major side effects, he said, included tingling or weakness in the extremities, low blood counts, liver toxicity and tumor lysis syndrome, a condition that can damage organs due to blood chemistry issues arising from the quick destruction of tumor cells. The most common side effects of any severity included low blood counts, fatigue, diarrhea and fever.

Monjuvi, a targeted drug that inhibits the activity of the DLBCL-fueling protein CD19, was approved based on results of the phase 2 L-MIND study that demonstrated a 43% complete response rate and an 18% partial response rate in 80 previously treated adult patients who were prescribed the drug along with the targeted medication Revlimid (lenalidomide), with a median duration of response of 21.7 months. The drug is approved in combination with Revlimid for patients with recurrent or resistant DLBCL who are not eligible for, or did not agree to undergo, bone marrow transplant using their own stem cells, Ajebo said.

Serious side effects occurred in 52% of patients, he said, and included low blood counts and infections. The drug caused fatal reactions in 5% of patients, including stroke, respiratory failure, progressive multifocal leukoencephalopathy (a virus that infects the brain) and sudden death.

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Novel Targeted Drugs are Changing the Treatment of Diffuse Large B-Cell Lymphoma - Curetoday.com

Bone Marrow Stem Cells Comments Off on Novel Targeted Drugs are Changing the Treatment of Diffuse Large B-Cell Lymphoma – Curetoday.com | November 5th, 2020

This article was originally published here

Stem Cell Res. 2020 Oct 15;49:102030. doi: 10.1016/j.scr.2020.102030. Online ahead of print.

ABSTRACT

Multiple myeloma (MM) is a hematological cancer characterized by an uncontrolled proliferation of antibody-secreting plasma cells within the bone marrow. Currently, cell therapy such as chimeric antigen receptor T-cell (CAR-T) based on induced pluripotent stem cells (iPSCs) has received attention for treating MM. However, the generation of iPSCs from MM patients appears to be very rarely reported. Here we generated an iPSC line from CD34+ bone marrow cells of a patient with MM using human placenta-derived cell conditioned medium (hPCCM), offering a relatively high efficiency in humanized conditions. This iPSC line might be a useful model for research on MM.

PMID:33142253 | DOI:10.1016/j.scr.2020.102030

Read more:
Generation of normal induced pluripotent stem cell line KUMCi002-A from bone marrow CD34+ cells of patient with multiple myeloma disease having 13q...

Bone Marrow Stem Cells Comments Off on Generation of normal induced pluripotent stem cell line KUMCi002-A from bone marrow CD34+ cells of patient with multiple myeloma disease having 13q… | November 5th, 2020

Development of limited, chronic graft-vs-host disease (GVHD) following allogeneic hematopoietic stem cell transplantation (HSCT) was associated with a survival benefit for patients with high-risk myelodysplastic syndrome (MDS), according to results of a retrospective study published in Clinical Cancer Research.1

MDS is a heterogeneous group of clonal hematopoietic stem cell disorders characterized by an inadequate production of normal, mature blood cells in bone marrow.

At the present time, the only curative treatment for patients with MDS is allogeneic HSCT. Although risks associated with this approach include posttransplant relapse, as well as the development of acute and/or chronic GVHD, previous findings from studies of patients with acute leukemia treated with allogeneic HSCT have shown potent graft-vs-tumor effects manifesting as lower mortality in those patients who subsequently experienced chronic GVHD.

The clinical data used in this study were collected from more than 300 HSCT centers throughout Japan by the Japanese Data Center for Hematopoietic Cell Transplantation.

MDS was characterized as low- or high-risk disease according to the

French-American-British or World Health Organization classification schemes, depending on the year of diagnosis.2,3 Consensus criteria were used to assign GVHD severity and distinguish acute and chronic forms of the condition.

Study inclusion criteria dictated patients should be aged 16 through 70 years, had received first allogeneic HSCT between 2001 and 2017, had achieved neutrophil engraftment, and had a follow-up period of over 60 days.

Of the 3119 patients included in this study, 1193 and 1926 were classified as having low- and high-risk disease, respectively. In the overall group, the median patient age was 54 years, more than 90% of patients had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, and 85% were diagnosed with de novo disease.

At a median follow-up of 55 months, rates of 5-year overall survival (OS) were 63% and 48% for those with low- and high-risk disease, respectively (P <.001). The cumulative incidence of posttransplantation relapse at 5 years was approximately twice as high for those with high-risk disease (29%) compared with those with low-risk disease (15%; P <.001), although the cumulative incidence of nonrelapse mortality was similar in the 2 groups: 25% (low-risk disease) and 27% (high-risk disease; P =.338).

Multivariate analyses accounting for all confounding variables performed to evaluate these transplant outcomes in patient subgroups defined according to disease risk, as well the severity of GVHD and whether it was classified as acute or chronic, revealed the following:

In summarizing the results of this study, the study authors emphasized that these data demonstrated a survival benet of the graft-versus-MDS effect is present only in high-risk MDS patients with limited chronic GVHD.1

Authors of an accompanying editorial noted that in recent years, the mutational spectrum in MDS has become more associated with clinical phenotype and prognosis, and selection of a patient with MDS for HSCT has begun to incorporate the mutational landscape of the patients disease. Thus, one will have to be cautious in extrapolating the current data to ongoing and future trials, which have begun to incorporate molecular information.4

References

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Survival Benefit of GVHD in MDS Is Limited to Specific Patient Subgroup - Cancer Therapy Advisor

Bone Marrow Stem Cells Comments Off on Survival Benefit of GVHD in MDS Is Limited to Specific Patient Subgroup – Cancer Therapy Advisor | November 5th, 2020

NEW YORK, Nov. 4, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc.,(NYSE AMERICAN: ATNM) ("Actinium") today announced that two abstracts on the Company's Antibody Radiation Conjugate (ARC) Iomab-B were accepted for oral presentations at the 2020 American Society of Hematology (ASH) annual meeting that is being held virtually December 5-8, 2020.

"This is an exciting fourth quarter for the company and we are honored to have multiple oral presentations at this year's ASH conference. Our 3 oral presentations and one poster presentation demonstrate the clinical progress we have seen not only with Iomab-B, but our other programs including Actimab-A in combination with novel and approved therapeutic agents," stated Sandesh Seth, Actinium's Chairman and CEO. "We look forward to presenting the Iomab-B data in further detail during the two oral presentations on the Iomab-B SIERRA study at ASH in December. The company remains on track to report safety and feasibility data from 75% of the patients to be enrolled in SIERRA, as well as to complete the ad hoc interim analysis in the fourth quarter."

Mark Berger, Actinium's Chief Medical officer, said, "We are encouraged that we continue to see positive ongoing results from our Phase 3 pivotal SIERRA trial in relapsed or refractory Acute Myeloid Leukemia (R/R AML) patients. In the Iomab-B Phase 3 trial we continue to see 100% engraftment in patients receiving a therapeutic dose of Iomab-B in the treatment arm whereas 83% of control arm patients failed salvage therapy, which includes the recently approved targeting agents such as venetoclax. This high failure rate demonstrates the significant need that exists in R/R AML and represents the paradigm shift we are looking to initiate with Iomab-B. The strong safety and feasibility data we have seen thus far gives us confidence that these older patients with active AML may benefit by undergoing a potentially curative bone marrow transplant which they could not receive otherwise."

Details & Highlights for Oral Presentations

Note: The two abstractsincludeSIERRA Phase 3 trial data available to the company from its CRO prior to August 10, 2020, the ASH submission cutoff date. Per ASH rules, updated data sets are permitted to be included in the live presentations.

OralPresentationTitle:

Personalized Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia Results in Successful Donor Hematopoietic Cells Engraftment with the Timing of Engraftment Not Related to the Radiation Dose Delivered

Publication Number:

193

Session Name:

721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

Session Date:

Saturday, December 5, 2020

Presentation Time:

1:00 PM PT / 4:00 PM ET

Phase 3 SIERRA Preliminary Results

Baseline Characteristics

Randomized to Iomab-B(N=53)

Randomized to Conventional Care (CC)(N=53)

Age (yrs, median, range)

64 (55-77)

65 (55-77)

Molecular & Cytogenetic Risk

Favorable: 2%Intermediate: 33%

Adverse: 65%

Favorable: 4%

Intermediate: 30%

Adverse: 66%

% TransplantedIntent-to-Treat Group

87% (46/53)

17% (9/53)

59% (26/44)

Results

Received Therapeutic dose of Iomab-B & Transplanted (N=46)****

Eligible to Receive Std. of Care Transplant Post-Salvage (N=9)

Evaluated for Crossover (N=44)*****

Cross-over Rate

n/a

n/a

Received Therapeutic Dose of Iomab-B (N=26)

Transplanted (N=26)

59% (26/44)

% Transplanted

100% (46/46)

17% (9/53)

100% (26/26)

BM Blast % @ baseline (median, range)

26 (4-95)

14 (5-97)

30 (6-87)

BM Blast % pre-HCT (median, range)

26 (4-95)

1 (0-3)*

32.5 (2-75)

Days to ANC Engraftment

14 (9-22)***

17 (13-83)#

14 (10-37)**

Days to Platelet Engraftment

17 (4-39)***

22 (8-35)#

19 (1-38)**

Days to HCT (Post Randomization)

30 (23-60)

66 (51-86)

65 (36-161)^

Myeloablative Dose Delivered to Bone Marrow

14.7 (4.6-32) Gv

n/a

14.4 (6.3-30) Gv

540 (313-1008) mCi

632 (354-1027) mCi

Chimerism>/=95% by D100

91% (39/43^ Evaluable)

67% (4/6^^ Evaluable)

87% (20/23^^^ Evaluable)

100-day non-Relapse Transplant-Related Mortality

5% (2/40 Evaluable)

25% (2/8 Evaluable)

8% (2/24 Evaluable)

*1 pt with 8% BM blasts on D42 with CRp on D50, ** ANC engraftment data not available (N=3), platelet engraftment data not available (N=4); *** ANC engraftment data not available (N=4), platelet engraftment data not available (N=9), ^ 1 patient at 161 days had delayed transplant due to infection and respiratory failure, received Iomab & transplant when stable, # ANC and platelet engraftment data not available (N=2)

**** No Therapy Dose (7) due to: Declining KPS (4), Infusion Reaction (1), Unfavorable Biodistribution (1), Post-Randomization Eligibility (1); 1 Pending Treatment.

*****Ineligible for Iomab-B HCT after crossover evaluation - 13: due to Hospice Care/Progression (4), Declined/Ineligible for HCT (5), Died Pre-Crossover (4). 4 Received Dosimetry but No Therapy Dose due to Declining KPS; 2 Pending Evaluation for Crossover.

^ Did not achieve 95% chimerism (4); Data pending (2); Died (1); ^^ Did not achieve 95% chimerism (4); Data pending (1); ^^^Did not achieve 95% chimerism (4); Data pending (2);

Oral PresentationTitle:

High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia

Publication Number:

135

Session Name:

721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

Session Date:

Saturday, December 5, 2020

Presentation Time:

9:30 AM PT / 12:30 PM ET

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Actinium Announces Two Oral Presentations Featuring Data and Findings from the Phase 3 SIERRA Trial of Iomab-B at the 62nd American Society of...

Bone Marrow Stem Cells Comments Off on Actinium Announces Two Oral Presentations Featuring Data and Findings from the Phase 3 SIERRA Trial of Iomab-B at the 62nd American Society of… | November 5th, 2020

Stem Cell Therapy Market Size And Forecast

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Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

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Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

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North America Latin America Middle East Asia-Pacific Africa Europe

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Stem Cell Therapy Market Size, Key Development Trends, and Growth Projection to 2027 - Stock Market Vista

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy Market Size, Key Development Trends, and Growth Projection to 2027 – Stock Market Vista | November 5th, 2020

The ability to grow and reproduce is a fundamental property of living organisms. Whether an organism is composed of a single cell or trillions of cells, individual cells must be able to grow and divide in an appropriately regulated fashion.

Cell growth is accomplished through the synthesis of new molecules of proteins, nucleic acids, carbohydrates and lipids. As the accumulation of these molecules causes the volume of a cell to increase, the plasma membrane grows to prevent the cell from burst-ing.

But cells cannot continue to enlarge indefinitely; as a cell grows larger, there is an accompanying decrease in its surface area/volume ratio and hence in its capacity for ef-fective exchange with the environment.

Therefore, cell growth is generally accompanied by cell division, whereby one cell gives rise to two new daughter cells (The term daughter is used by convention and does not indicate that cells have gender).

For single-celled organisms, cell division increases the total number of individuals in a population. In multicellular organisms, cell division either increases the number of cells, leading to growth of the or-ganism, or replaces cells that have died. In an adult human, for example, about two million stem cells in bone marrow divide every second to maintain a constant num-ber of red blood cells in the body. When cells grow and divide, the newly formed daugh-ter cells are usually genetic duplicates of the parent cell, containing the same (or virtually the same) DNA sequences.

Therefore, all the genetic information in the nucleus of the parent cell must be duplicated and carefully distributed to the daughter cells during the division process.

In accomplishing this task, a cell passes through a series of discrete stages, collectively known as the cell cycle. The cell cycle begins when two new cells are formed by the division of a single parental cell and ends when one of those cells divides again into two cells.

To early cell biologists studying eukaryotic cells with the mi-croscope, the most dramatic events in the life of a cell were those associated with the point in the cycle when the cell actually divides. This division process, called the M phase, involves two overlapping events in which the nucleus divides first and the cytoplasm second. Nuclear division is called mitosis, and the division of the cytoplasm to pro-duce two daughter cells is termed cytokinesis.

The stars of the mitotic drama are the chromosomes.

The beginning of mitosis is marked by condensation (coiling and folding) of the cells chromatin, which generates chromosomes that are thick enough to be individually discernible under the micro-scope.

Because DNA replication has already taken place, each chromosome actually consists of two chromosome copies that remain attached to each other until the cell divides. As long as they remain attached, the two new chromosomes are referred to as sister chromatids.

As the chromatids become visible, the nuclear envelope breaks into fragments. Then, in a stately ballet guided by the mi-crotubules of the mitotic spindle, the sister chromatids separate and each now a full-fledged chromosome move to opposite ends of the cell.

By this time, cytokinesis has usually begun, and new nuclear membranes envelop the two groups of daughter chromosomes as cell division is completed. While visually striking, the events of the mitotic phase account for a relatively small portion of the total cell cycle; for a typical mammalian cell, the mitotic phase usually lasts less than an hour.

Cells spend the majority of their time in the growth phase between divisions, called interphase. Most cellular contents are synthesised continuously during interphase, so cell mass gradually increases as the cell approaches division.

During interphase the amount of nuclear DNA doubles, and experiments using radioactive DNA precursors have shown that the new DNA is synthesised during a particular portion of interphase named the S phase (S for synthesis). A time gap called G1 phase separates the S phase from the preceding M phase, and a second gap, the G2 phase, separates the end of S phase from the beginning of the next M phase.

Although the cells of a multicellular organism divide at varying rates, most studies of the cell cycle involve cells growing in culture, where the length of the cycle tends to be similar for different cell types. We can easily determine the overall length of the cell cycle the generation time for cultured cells by counting the cells under a microscope and determining how long it takes for the population to double.

In cultured mammalian cells, for example, the total cycle usually takes about 18-24 hours. Once we know the total length of the cycle, it is possible to determine the length of specific phases. To determine the length of the S phase, we can expose cells to a radioactively labelled DNA precursor for a short period of time and then examine the cells by autoradiography.

The fraction of cells with silver grains over their nuclei represents the fraction of cells that were somewhere in S phase when the radioactive compound was available. When we mul-tiply this fraction by the total length of the cell cycle, the result is an estimate of the average length of the S phase.

For mammalian cells in culture, this fraction is often around 0.33, which indicates that S phase is about six to eight hours in length. Similarly, we can estimate the length of the M phase by multiplying the generation time by the percentage of the cells that are actually in mitosis at any given time.

This percentage is called the mitotic index.

The mitotic index for cultured mammalian cells is often about three to five per cent, which means that M phase lasts less than an hour (usually 30-45 minutes). In contrast to the S and M phases, whose lengths tend to be quite similar for different mammalian cells, the length of G1 is quite variable, depending on the cell type. Although a typical G1 phase lasts 8-10 hours, some cells spend only a few minutes or hours in Gl, whereas others are delayed for long periods of time. During Gl, a major decision is made as to whether and when the cell is to divide again. Cells that become arrested in Gl, awaiting for a signal that will trigger re-entry into the cell cycle and a commitment to divide, are said to be in G0 (G zero).

Other cells exit from the cell cycle entirely and undergo terminal differentiation, which means that they are destined never to divide again; most of the nerve cells in our body are in this state. In some cells, a transient arrest of the cell cycle can also occur in G2. In general, however, G2 is shorter than Gl and is more uniform in duration among different cell types, usually lasting 4-6 hours.

The writer is associate professor and head, department of botany, Ananda Mohan College, Kolkata.

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Putting it all together - The Statesman

Bone Marrow Stem Cells Comments Off on Putting it all together – The Statesman | November 5th, 2020

NEW YORK, Nov. 4, 2020 /PRNewswire/ -- Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, announced that an abstract demonstrating clinical benefit of the company's lead product candidate ARU-1801 has been published online and will be the subject of an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will take place virtually from December 5 to 8. Michael S. Grimley, M.D., Professor of Clinical Pediatrics, Medical Director of the Division of Bone Marrow Transplantation and Immune Deficiency at the Cincinnati Children's Hospital Medical Center, will present the data at 2:15 PM ET on December 7, 2020. Today the abstract was published online and will be published in the upcoming supplemental issue of Blood.

Data presented at ASH is from the MOMENTUM study, an open label Phase 1/2 clinical trial examining ARU-1801 as a one-time potentially curative gene therapy for individuals with sickle cell disease (SCD). The MOMENTUM study, which continues to enroll patients, examines ARU-1801, an autologous cell therapy leveraging a modified gamma globin lentivirus vector, in individuals with severe SCD. Unlike investigational gene therapies that require fully myeloablative conditioning, ARU-1801 is given with reduced intensity conditioning (RIC), which is a lower dose chemotherapy. ARU-1801 is designed to address the limitations of current curative treatment options, such as low donor availability and the risk of Graft-versus-Host Disease (GvHD) seen with allogeneic stem cell transplants. The data to be presented at ASH highlights participants dosed with product manufactured with both the original academic manufacturing process and the enhanced Process II.

"The clinical results thus far demonstrate that ARU-1801 holds significant promise for achieving durable responses with a reduced intensity conditioning approach to gene therapy," said Dr. Grimley, a principle investigator in the MOMENTUM study. "Given the impact chemotherapy toxicity has on physician and patient decision making around treatment options, ARU-1801 has the potential to be a unique option for SCD patients seeking gene therapy."

Abstract and Oral Presentation Information

Title: Early Results from a Phase 1/2 Study of ARU-1801 Gene Therapy for Sickle Cell Disease (SCD): Manufacturing Process Enhancements Improve Efficacy of a Modified Gamma Globin Lentivirus Vector and Reduced Intensity Conditioning TransplantPublication Number: 680Session Name: 114. Hemoglobinopathies, Excluding ThalassemiaClinical: Novel Treatments for Sickle Cell DiseaseDate:Monday, December 7, 2020Session Time:1:30 PM - 3:00 PMPresentation Time:2:15 PM

About ARU-1801ARU-1801 is a one-time potentially curativeinvestigational gene therapy for individuals living with sickle cell disease. This product candidate was designed to address the limitations of current treatment options including chemotherapy toxicity, donor availability, andchronic administration and replace it with a curative therapy. ARU-1801 incorporates a patented modified gamma-globin into autologous stem cells, with the aim of restoring normal red blood cell function through increased levels of fetal hemoglobin. The high potency of the modified gamma globin enables ARU-1801 engraftment with only reduced intensity conditioning (RIC). Preliminary clinical data from the MOMENTUMstudy, an ongoing Phase 1/2 trial in patients with sickle cell disease, demonstrate continuing durable reductions in disease burden.

The MOMENTUM StudyAruvant is currently conducting the MOMENTUM study, which is evaluating ARU-1801, a one-time only potentially curative gene therapy for patients with SCD. This Phase 1/2 study currently is enrolling individuals with SCD, and information may be found at http://www.momentumtrials.com.

About Aruvant SciencesAruvant Sciences, part of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing and commercializing gene therapies for the treatment of rare diseases. The company has a talentedteamwith extensive experience in the development, manufacturing and commercialization of gene therapy products. Aruvant has an activeresearchprogram with a lead product candidate, ARU-1801, in development for individuals suffering fromsickle cell disease(SCD). ARU-1801 is an investigational lentiviral gene therapy currently in aclinical trial,the MOMENTUM study, as a potential one-time curative treatment for SCD. Preliminary clinical data from the ongoing Phase 1/2 study demonstrated engraftment of ARU-1801 and amelioration of SCD is possible with one dose of low intensity chemotherapy. For more information on the clinical study, please visit http://www.momentumtrials.com and for more on the company, please visitwww.aruvant.com.

SOURCE Aruvant Sciences

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Aruvant Announces Updated Data to be Presented in Oral Presentation of ARU-1801 Data at the 62nd American Society of Hematology (ASH) Annual Meeting -...

Bone Marrow Stem Cells Comments Off on Aruvant Announces Updated Data to be Presented in Oral Presentation of ARU-1801 Data at the 62nd American Society of Hematology (ASH) Annual Meeting -… | November 5th, 2020

NEW YORK, Nov. 04, 2020 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Precigen, Inc. f/k/a Intrexon Corporation (NASDAQ: PGEN; XON), Royal Caribbean Group (NYSE: RCL), Mesoblast Limited (NASDAQ: MESO), and Loop Industries, Inc. (NASDAQ: LOOP). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link

Precigen, Inc. f/k/a Intrexon Corporation (NASDAQ: PGEN; XON)

Class Period: May 10, 2017 to September 25, 2020

Lead Plaintiff Deadline: December 4, 2020

On September 25, 2020, the U.S. Securities and Exchange Commission (SEC) issued a cease and desist order against Precigen. The cease and desist order involved inaccurate reports concerning the companys purported success converting relatively inexpensive natural gas into more expensive industrial chemicals using a proprietary methane bioconversion (MBC) program. The order noted that the Company was primarily using significantly more expensive pure methane for the relevant laboratory experiments but was indicating that the results had been achieved using natural gas. The cease-and-desist order further stated that although the Company pitched the MBC program privately to numerous potential business partners over the course of 2017 and 2018 and [a] number of these potential partners performed due diligence on the MBC program including reviewing lab results and plans for commercialization. [The Company] has not yet found a partner for the MBC program.

The complaint, filed on October 5, 2020, alleges that throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose to investors that: (1) the Company was using pure methane as feedstock for its announced yields for its methanotroph bioconversion platform instead of natural gas; (2) yields from natural gas as a feedstock were substantially lower than the aforementioned pure methane yields; (3) due to the substantial price difference between pure methane and natural gas, pure methane was not a commercially viable feedstock; (4) the Companys financial statements for the quarter ended March 31, 2018 were false and could not be relied upon; (5) the Company had material weaknesses in its internal controls over financial reporting; (6) the Company was under investigation by the SEC since October 2018; and (7) as a result of the foregoing, defendants public statements were materially false and misleading at all relevant times.

For more information on the Precigen class action go to: https://bespc.com/cases/PGEN

Royal Caribbean Group (NYSE: RCL)

Class Period: February 4, 2020 to March 17, 2020

Lead Plaintiff Deadline: December 7, 2020

The complaint, filed on October 7, 2020, alleges that throughout the Class Period defendants failed to disclose material facts about the Companys decrease in bookings outside China, instead maintaining that it was only experiencing a slowdown in bookings from China. The Action further alleges that defendants failed to disclose material facts about the Companys inadequate policies and procedures to prevent the spread of COVID-19 on its ships. The truth about the scope of the impact that COVID-19 had on the Companys overall bookings and the inability of Royal Caribbean to prevent the virus spread on its ships was revealed through a series of disclosures.

First, on February 13, 2020, Royal Caribbean issued a press release stating that it had canceled 18 voyages in Southeast Asia due to recent travel restrictions and further warning that recent bookings had been softer for its broader business.

On this news, Royal Caribbean shares fell over 3 percent.

Second, on February 25, 2020, Royal Caribbean filed its 2019 Form 10-K, indicating that COVID-19 concerns were negatively impacting its overall business.

On this news, Royal Caribbean shares fell over 14 percent.

Third, on March 10, 2020, Royal Caribbean withdrew its 2020 financial guidance, increased its revolving credit facility by $550 million, and announced that it would take cost-cutting actions due to the proliferation of COVID-19, further revealing that COVID-19 was severely impacting Royal Caribbeans 2020 customer booking and that its safety measures were inadequate to prevent the spread of the virus on its ships.

On this news, Royal Caribbean shares fell over 14 percent.

Fourth, on March 11, 2020, Royal Caribbeans largest competitor, Carnival, announced a 60-day suspension of all operations, prompting concern that Royal Caribbean would follow suit. At the same time, Royal Caribbean also cancelled two cruises, beginning a series of cancellations and suspensions to follow.

On this news, Royal Caribbean shares fell almost 32 percent.

Fifth, on March 14, 2020, Royal Caribbean announced a suspension of all global cruises for 30 days.

On this news, Royal Caribbean stock fell over 7 percent.

Sixth, on March 16, 2020, the Company revealed that global operations could be suspended longer than anticipated, announcing the cancellations of two additional cruises throughout April and into May.

On this news, Royal Caribbean shares fell over 7 percent.

Finally, on March 18, 2020, analysts downgraded Royal Caribbeans stock and slashed their price targets.

On this news, Royal Caribbean shares fell more than 19 percent.

For more information on the Royal Caribbean class action go to: https://bespc.com/cases/RCL

Mesoblast Limited (NASDAQ: MESO)

Class Period: April 16, 2019 to October 1, 2020

Lead Plaintiff Deadline: December 7, 2020

Mesoblast develops allogeneic cellular medicines using its proprietary mesenchymal lineage cell therapy platform. Its lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, the Company announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease (aGVHD).

In early 2020, Mesoblast completed its rolling submission of its Biologics License Application (BLA) with the FDA to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.

On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee (ODAC) meeting to be held on August 13, 2020. Therein, the FDA stated that Mesoblast provided post hoc analyses of other studies to further establish the appropriateness of 45% as the null Day-28 ORR for its primary endpoint. The briefing materials stated that, due to design differences between these historical studies and Mesoblasts submitted study, it is unclear that these study results are relevant to the proposed indication.

On this news, the Companys share price fell $6.09, or approximately 35%, to close at $11.33 per share on August 11, 2020.

On October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter (CRL) from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that the Company conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. The CRL also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity.

On this news, the Companys share price fell $6.56, or 35%, to close at $12.03 per share on October 2, 2020.

The complaint, filed on October 8, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that comparative analyses between Mesoblasts Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies; (2) that, as a result, the FDA was reasonably likely to require further clinical studies; (3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Mesoblast class action go to: https://bespc.com/cases/MESO

Loop Industries, Inc. (NASDAQ: LOOP)

Class Period: September 24, 2018 to October 12, 2020

Lead Plaintiff Deadline: December 14, 2020

On October 13, 2020, Hindenburg Research published a report alleging, among other things, that Loops scientists, under pressure from CEO Daniel Solomita, were tacitly encouraged to lie about the results of the companys process internally. The report also stated that Loops previous claims of breaking PET down to its base chemicals at a recovery rate of 100% were technically and industrially impossible, according to a former employee. Moreover, the report alleged that Executives from a division of key partner Thyssenkrupp, who Loop entered into a global alliance agreement with in December 2018, told us their partnership is on indefinite hold and that Loop underestimated both costs and complexities of its process.

On this news, the Companys share price fell $3.78, or over 32%, to close at $7.83 per share on October 13, 2020.

The complaint, filed on October 13, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that Loop scientists were encouraged to misrepresent the results of Loops purportedly proprietary process; (2) that Loop did not have the technology to break PET down to its base chemicals at a recovery rate of 100%; (3) that, as a result, the Company was unlikely to realize the purported benefits of Loops announced partnerships with Indorama and Thyssenkrupp; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Loop class action go to: https://bespc.com/cases/Loop

About Bragar Eagel & Squire, P.C.:Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit http://www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:Bragar Eagel & Squire, P.C.Brandon Walker, Esq. Melissa Fortunato, Esq.Marion Passmore, Esq.(212) 355-4648investigations@bespc.comwww.bespc.com

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Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Precigen, Royal Caribbean, Mesoblast, and Loop...

Bone Marrow Stem Cells Comments Off on Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Precigen, Royal Caribbean, Mesoblast, and Loop… | November 5th, 2020

Bones make up the skeletal system and serve the important function of giving the body support to be able to move. Whats inside the bones also is essential to personal health.

Bone marrow can be found in the center of bones. According to the online wellness resource Healthline, this viscous or spongy tissue comes in two types: red or yellow bone marrow. Both have specific functions in the body.

Red bone marrow is essential for a process called hematopoiesis, or blood cell production. Hematopoietic stem cells in the red bone marrow can develop into key blood cells, including red blood cells, which carry oxygen-rich blood to the body; platelets, which help blood to clot; and white blood cells, which are involved in immune system responses.

Yellow bone marrow is involved with the storage of fats. These fats can be used as an energy source as needed. Yellow bone marrow also contains mesenchymal stem cells that can develop into bone, fat, muscle, or cartilage cells.

Over time, yellow bone marrow replaces red bone marrow in most of the bones in the adult body. Only a few bones, such as the pelvis, skull, vertebrae, and ribs, will contain red bone marrow into adulthood.

According to Medical News Today, bone marrow makes more than 200 billion new blood cells every day. Most blood cells in the body develop from bone marrow cells.

Issues with bone marrow can produce a host of side effects. Fatigue or weakness, fever, increased infections, easy bleeding and bruising, and specific conditions like leukemia and anemia can develop as a result of bone marrow-related problems. In some cases, a bone marrow transplant may be needed to replace diseased or nonfunctioning bone marrow. It also may help regenerate a new immune system that can fight leukemia or other cancers.

Bone marrow transplants also may involve replacing existing bone marrow with genetically healthy bone marrow to prevent future damage from certain genetic diseases, according to Medical News Today. Bone marrow transplants can come from ones own stem cells, a twin, a sibling, parent, or an unrelated donor. Marrow transplants also may come from stored umbilical cord blood.

Bone marrow is vital to the overall health and function of the human body. Bone marrow affects just about every other cell due to its unique relationship with blood production and immune function.

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The roles bone marrow plays in the body - Williston Daily Herald

Bone Marrow Stem Cells Comments Off on The roles bone marrow plays in the body – Williston Daily Herald | November 3rd, 2020

Only two decades ago, stem cell therapy was highly regulated in the United States and other countries but it was well underway in Hadassah Hospitals labs in Jerusalem. Never would we have imagined that the US expansion of one of the key clinical trials conducted in our labs in Israel would be later funded by Californias Stem Cell Institute.

In 2004, California had the foresight to advance this critical area of research, and Hadassah advocates played a major role in the passing of an unprecedented statewide ballot initiative that authorized state funding for stem cell research. This marked the passage of Proposition 71 in 2004.

Fast forward to today. Hadassahs commitment to stem cell research led the Californians for Stem Cell, Research, Treatments and Cures Initiative effort in 2020 to reach out for help with their grassroots effort to qualify the latest stem cell funding initiative for the November ballot. It qualified with your help, and I hope that in a few short weeks well be celebrating the passage of Proposition 14, which will provide $5.5 billion to help accelerate development of treatments and cures for life-threatening diseases and conditions.

The power of stem cells is mind-blowing: We are able to use these cells to replace damaged or diseased tissue, and in this way, treatments or cures for diseases like age-related macular degeneration, ALS, MS, Parkinsons, Alzheimers and diabetes could be a reality in the foreseeable future.

I come to this subject from a place of personal sorrow.

I watched my father-in-law, Irv, suffer for 12 and a half years with ALS, a man I loved as if he were my own father. He fought and fought, he made every minute of his battle meaningful, soaking as much life as he could, until he couldnt. Irv is the reason why I became involved in Hadassah because of their cutting-edge medical research and he is the reason that Im writing to you now.

Today, Hadassah is doing incredible things in stem cell research, and the stunning results of their clinical trials have riveted the worldwide medical community.

Of course, the research most personal to me is the ALS research. Hadassah researchers conducted the worlds first clinical trial using the patients own bone marrow stem cells to treat ALS.Pikuach nefesh, the preservation of life, is the most important obligation in Judaism, and the one that drives Hadassah. With the potential of stem research, we have the ability to save millions of lives throughout the world.

And, with the promise of stem cells, we can accelerate the development of treatments and cures for life-threatening diseases and conditions that affect someone in nearly half of all California families.

I believe that stem cell research is going to allow our children to look at the major diseases that plague our modern world the way we now view polio.That potential will not reveal itself on its own, nor did it with polio. It took decades of research and funding for a polio vaccine to be fully developed, tested and made available widely.

There are no medical miracles. Medical advancement happens because of research. Research takes will, knowledge, chutzpah and, of course, money. The path to get a therapy approved by the Food and Drug Administration can take 12 to 15 years, requires thousands of patients for clinical trials and costs billions of dollars. from life-saving vaccines, to pioneering cancer treatments, to the sequencing of the human genome.w When research stalls for lack of funding, opportunities are missed. Promising avenues go unexplored.

The passage of Proposition 14 would help to overcome those hurdles and create a streamlined process that delivers much-needed treatments to patients who have few options. How amazing would it be to be part of making medical history.I am so proud to be a member of Hadassah, which is not only leading the way in stem cell research but also doing its research in service to humanity. Together, we can make medical discoveries happen and continue to set the pace for the worldwide medical community.

I wish that my father-in-law was here to give you his final thumbs up.

Stacey Dorenfeld is the National State Advocacy Co-Chair and the Hadassah Southern California Advocacy Chair.

The views and opinions expressed in this article are the authors own and do not necessarily reflect those of the Forward.

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California Proposition 14 is about pikuach nefesh heres why - Forward

Bone Marrow Stem Cells Comments Off on California Proposition 14 is about pikuach nefesh heres why – Forward | November 3rd, 2020

Global Cell Banking Outsourcing Market: Overview

The global cell banking outsourcing market is likely to be driven by the rising demand for biopharmaceutical production targeting novel active sites, stem cell therapy, and gene therapy. A cell bank is a facility storing cells extracted from various organ tissue and body fluids so as to cater to the needs of the future. The cell banks make storage of cells with an elaborate characterization of the entire cell line as it reduces the possibilities of cross contamination. These benefits are estimated to fuel expansion of the global cell banking outsourcing market over the timeframe of assessment, from 2020 to 2030.

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Cell banking outsourcing industries engage testing, characterization, storage, and collection of tissues, cell lines, and the cells. These activities are done to assist in the production of biopharmaceuticals and in the research and development activities so as to ensure minimum adverse effects and high effectiveness. The procedure of the cell storage involves first proliferation of cells, which then multiplies in a huge number of identical cells and is then put inside cryovials safety for use in future. Cells are primarily utilized in the production of regenerative medicine. A surge in the number of cell banks together with the high demand for stem cell therapies is likely to work in favor of the global cell banking outsourcing market over the tenure of analysis, from 2020 to2030.

The global cell banking outsourcing market has been segmented on the basis of four important parameters, which are bank type, phase, cell type, and region.

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Global Cell Banking Outsourcing Market: Notable Developments

The global cell banking outsourcing market is considered a fairly competitive market and is marked with the presence of many leading market players. The companies in this market are forging mergers, partnerships, and collaborations so as to gain larger revenue and market share. The following development is expected to play an important role in the market:

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Global Cell Banking Outsourcing Market: Key Trends

The global cell banking outsourcing market is characterized by the presence of the following restraints, drivers, and opportunities.

High Demand for Stem Cell Therapies to Trigger Growth of the Market

The rising number of stem cell therapies across the globe primarily influences the global cell banking outsourcing market. According to a survey conducted by World Network for Blood and Marrow Transplantation (WBMN), nearly 1 million hematopoietic stem cell transplantation processes were conducted in between 2006 to 2014. These figure comprised removal of stem cells procedures from peripheral blood or bone marrow, proliferating, and then finally storing them cell banks for future use by patients. Stem cell therapies are able to multiple disease, such as amyotrophic lateral sclerosis, type 1 diabetes, cancer, Alzheimer's disease, Parkinson's disease, and so on. Ability to cure such a wide variety of diseases is expected to propel growth of the global cell banking outsourcing market in the years to come.

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Global Cell Banking Outsourcing Market: Geographical Analysis

North America is expected to dominate the global cell banking outsourcing market throughout the timeframe of analysis, from 2020 to 2030. Such high growth of the North America market is ascribed to the increased production of antibiotics, therapeutics protein, and vaccines. In addition, presence of several biopharmaceutical companies in the region is anticipated to foster growth of the cell banking outsourcing market in North America in the near future.

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Cell Banking Outsourcing Market: High Demand for Stem Cell Therapies to Trigger Growth of the Market - BioSpace

Bone Marrow Stem Cells Comments Off on Cell Banking Outsourcing Market: High Demand for Stem Cell Therapies to Trigger Growth of the Market – BioSpace | November 3rd, 2020

Global Hematopoietic Stem Cell Transplantation Market Report from AMA Research highlights deep analysis on market characteristics, sizing, estimates and growth by segmentation, regional breakdowns& country along with competitive landscape, players market shares, and strategies that are key in the market. The exploration provides a 360 view and insights, highlighting major outcomes of the industry. These insights help the business decision-makers to formulate better business plans and make informed decisions to improved profitability. In addition, the study helps venture or private players in understanding the companies in more detail to make better informed decisions.

Major Players in This Report Include,

Gilead Sciences Inc. (United States), Thermo Fisher Scientific (United States), PromoCell (Germany), CellGenix Technologie Transfer GmbH (Germany), Cesca Therapeutics Inc.(United States), R&D Systems (United States), Genlantis (United States), Lonza Group Ltd.(Switzerland), TiGenix N.V.(Belgium), ScienCell Research Laboratories (United States), Regen Biopharma Inc. (United States), China Cord Blood Corp (Hong Kong) and CBR Systems Inc. (United States).

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Analyst at AMA have conducted special survey and have connected with opinion leaders and Industry experts from various region to minutely understand impact on growth as well as local reforms to fight the situation. A special chapter in the study presents Impact Analysis of COVID-19 on Hematopoietic Stem Cell Transplantation Market along with tables and graphs related to various country and segments showcasing impact on growth trends.

Definition

Despite the increasing availability of smart antineoplastic therapies in recent years, Hematopoietic stem cell transplantation (HSCT) remains an optimal treatment modality for many hematologic malignancies. HSCT is one of a range of therapeutic options which is available to patients suffering from various diseases. It is a widely accepted treatment for many life-threatening diseases. The treatment is available to patients who suffer from refractory or relapsing neoplastic disease and non-neoplastic genetic disorders, as well as from chronic bone marrow failure. Hematopoietic stem cells are young or immature blood cells which are found to be living in bone marrow. These blood cells when matures in bone marrow very few enters into bloodstream.

Global Hematopoietic Stem Cell Transplantation Market Report offers a detailed overview of this market and discusses the dominant factors affecting the growth of the market. The impact of Porters five armies on the market over the next few years has been discussed for a long time in this study. We will also forecast global market size and market outlook over the next few years.

Types of Products, Applications and Global Hematopoietic Stem Cell Transplantation Market Report Geographical Scope taken as the Main Parameter for Market Analysis. This Research Report Conducts an assessment of the industry chain supporting this market. It also provides accurate information on various aspects of this market, such as production capacity, available production capacity utilization, industrial policies affecting the manufacturing chain and market growth.

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In this research study, the prime factors that are impelling the growth of the Global Hematopoietic Stem Cell Transplantation market report have been studied thoroughly in a bid to estimate the overall value and the size of this market by the end of the forecast period. The impact of the driving forces, limitations, challenges, and opportunities has been examined extensively. The key trends that manage the interest of the customers have also been interpreted accurately for the benefit of the readers.

The Hematopoietic Stem Cell Transplantation market study is being classified by Type, Applicationsand major geographies with country level break-up that includes South America (Brazil, Argentina, Rest of South America), Asia Pacific (China, Japan, India, South Korea, Taiwan, Australia, Rest of Asia-Pacific), Europe (Germany, France, Italy, United Kingdom, Netherlands, Rest of Europe), MEA (Middle East, Africa), North America (United States, Canada, Mexico).

The report concludes with in-depth details on the business operations and financial structure of leading vendors in the Global Hematopoietic Stem Cell Transplantation market report, Overview of Key trends in the past and present are in reports that are reported to be beneficial for companies looking for venture businesses in this market. Information about the various marketing channels and well-known distributors in this market was also provided here. This study serves as a rich guide for established players and new players in this market.

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Current Scenario Analysis for Decision Framework

Key Strategic Developments in Hematopoietic Stem Cell Transplantation Market:

The research includes the key strategic activities such as Research & Development (R&D) initiatives, Merger & Acquisition (M&A) completed, agreements, new launches, collaborations, partnerships & (JV) Joint ventures, and regional growth of the key competitors operating in the market at global and regional scale to overcome current slowdown due to COVID-19.

Key Market Features in Global Hematopoietic Stem Cell Transplantation Market

The report highlights Hematopoietic Stem Cell Transplantation market features, including revenue size, weighted average regional price, capacity utilization rate, production rate, gross margins, consumption, import & export, demand & supply, cost bench-marking in Hematopoietic Stem Cell Transplantation market share and annualized growth rate (Y-o-Y) and Periodic CAGR.

Extracts from Table of Contents

Global Hematopoietic Stem Cell Transplantation Market Research Report

Chapter 1 Global Hematopoietic Stem Cell Transplantation Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Revenue (Value, Volume*) by Region

Chapter 5 Global Supplies (Production), Consumption, Export, Import by Regions

Chapter 6 Global Revenue (Value, Volume*), Price* Trend by Type

Chapter 7 Global Market Analysis by Application

.continued

This report also analyzes the regulatory framework of the Global Markets Hematopoietic Stem Cell Transplantation Market Report to inform stakeholders about the various norms, regulations, this can have an impact. It also collects in-depth information from the detailed primary and secondary research techniques analyzed using the most efficient analysis tools. Based on the statistics gained from this systematic study, market research provides estimates for market participants and readers.

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Hematopoietic Stem Cell Transplantation Market New Investments Expected to boost the Demand by 2025 - The Daily Philadelphian

Bone Marrow Stem Cells Comments Off on Hematopoietic Stem Cell Transplantation Market New Investments Expected to boost the Demand by 2025 – The Daily Philadelphian | November 3rd, 2020