Stem Cell Clinic

Stem Cell Banking Market Size, Share, Global Future Trend, Segmentation, Business Growth, Top Key Players, Opportunities and Forecast to 2027 – Owned

By Stell Cell Research

New Jersey, United States,- The latest report published by Market Research Intellect on Stem Cell Banking Market provides crucial market insights along with detailed segmentation analysis. The report examines key driving factors that are expected to drive the growth of the market.

Global Stem Cell Banking Market Research Report gives knowledgeable information on various market situations, for example, potential development factors, factors controlling the development, market opportunities, and dangers to the worldwide market. Also, the report broadly centers around the competitive analysis of Stem Cell Banking Market. The competitive analysis segment incorporates key manufacturers, fresh players, providers, market strategies, potential chances, operation landscape, and analysis of the trends of the Stem Cell Banking market. The market results are centered around the current market scenario. To gauge and predict the degree of competition in this market. This report will likewise support all the manufacturers and speculators to have a superior comprehension of the investments to know where the market is heading.

Key highlights from COVID-19 impact analysis:

Unveiling a brief about the Stem Cell Banking market competitive scope:

The report includes pivotal details about the manufactured products, and in-depth company profile, remuneration, and other production patterns.

The research study encompasses information pertaining to the market share that every company holds, in tandem with the price pattern graph and the gross margins.

Stem Cell Banking Market, By Type

Stem Cell Banking Market, By Application

Other important inclusions in the Stem Cell Banking market report:

A brief overview of the regional landscape:

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Stem Cell Banking Market Size, Share, Global Future Trend, Segmentation, Business Growth, Top Key Players, Opportunities and Forecast to 2027 - Owned

Researcher John Craig Venter Is Awarded the 2020 Edogawa-NICHE Prize for His Accomplishment in Human Genome Research – Business Wire

By Stell Cell Research

TOKYO--(BUSINESS WIRE)--The Edogawa NICHE Prize for the year 2020 has been awarded to Dr. John Craig Venter for his contribution to research and development pertaining to the Human genome. This honor reflects Dr. Venter's lifetime accomplishments in the power of the genomics and specifically in the identification of the human genome which has radically transformed healthcare according to Prof. Gary Levy, chair, Edogawa NICHE awards committee (www.edogawanicheprize.org).

Edogawa NICHE Prize was Instituted in 2018, by the Jinseisha trust, and the Nichi-In Centre for Regenerative Medicine (NCRM), which honours scientists or clinicians whose contributions lead to the development of prevention, diagnosis or treatment of any disease, through an inter-disciplinary approach. Alumni of the Fujio Cup Quiz, a part of NCRM NICHE, (www.ncrmniche.org), have priority for nomination, a unique feature of this prize. Previous awardees include Prof James Till, University of Toronto, Canada for discovery of stem cells (2018) and Dr. Steven Rosenberg, National Institutes of Health, USA for his groundbreaking work on T-lymphocyte immunotherapy (2019).

Dr. Venter was born in Salt Lake City Utah on October 14, 1946. He started his college education at the College of San Mateo, CA and later studied Biochemistry in University of California, San Diego under biochemist Nathan O. Kaplan. After obtaining a PhD in Physiology and Pharmacology from UCSD, he became a Professor at the State University of New York and joined the National Institute of Health in 1984. He has founded Celera Genomics, The Institute of Genomic Research (TIGR), J.Craig Venter Institute (JCVI) and co-founded Human Longevity Inc and Synthetic Genomics.

His path breaking sequencing of the first human genome with the Human Genome Project further progressed to transfecting a cell with a synthetic chromosome, a feat that has opened up opportunities to develop novel solutions not only in healthcare, but also in environmental issues and energy domain.

The awarding of the Edogawa NICHE prize to Dr Venter is the most recent in a string of honors including United States Medal of Science (2008), Gardner Foundation International Award (2002), Paul Erlich and Ludwig Darmstaedter Prize (2001) and the King Faisal International Award of Science (2001). He was listed on Time Magazines list of the most influential people in the world.

The award ceremony date will be announced later.

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Researcher John Craig Venter Is Awarded the 2020 Edogawa-NICHE Prize for His Accomplishment in Human Genome Research - Business Wire

A question of scale the growing pains of cell-based meat – just-food.com

By Stell Cell Research

Memphis Meats' lab-produced meatballs

There is a frustrating, 'jam tomorrow' aspect to all the talk around cell-based meat.

Perhaps it is the tantalising prospect of what might be achieved by the men and women in labs and what it might mean for the future of food that makes us keep asking the question of when we will see something more than a prototype of meat created without harming animals.

But the answer always seem to be that we are a couple of years away.

However, there do seem to be signs of progress. Specifically, costs associated with the process, previously sky high, do seem to be coming down.

It should be remembered that it was back in 2013 when Mosa Meat of the Netherlands created the world's first lab-grown burger at the eye-watering cost of EUR250,000 (US$295,594 at today's conversion rate).

Here we are seven years later and the products are still in the lab, seemingly a long way from supermarket shelves.

On the face of it, even for a layman, what is being done in those labs is relatively easy to understand.

Stem cells are taken from the muscle of an animal and added to a nutrient rich-solution called cell culture medium typically containing vitamins, sugars and proteins and left to multiply, or fatten, to create meat.

The environmental and animal-welfare benefits of this process succeeding has meant the nascent industry has enjoyed more media attention and investment dollars than many other areas of food product development, with the exception of plant-based meat alternatives, also known as alt-protein.

But, as was demonstrated seven years ago, the central issue facing the industry is no longer proof of concept. It can be done, even with trickier marbled cuts of meat such as steak, but can it be done at scale and at an affordable cost?

Some investors think so as they continue to back cell-based meat companies, enticed by the prospect of getting in early to a development offering so much promise on paper (and lab desk).

In January, Memphis Meats of the US secured US$161m in new funding with meat giant Tyson Foods once again among the consortium of investors.

The California-based company said in January it will use the funds to build a pilot production plant, expand its team and to "hit a major milestone of launching products into the market". However, it has not set an actual launch date.

David Kay, Memphis Meats' senior manager of communications and operations, tells just-food the company needs to develop additional infrastructure for production, with a pilot production facility a key element.

"The focus is on reducing the cost of production and increasing production scale. On both of these issues, we have made very significant progress since we were founded in 2015," Kay insists.

Mosa Meat is still pushing hard to get a product ready to scale up. It too has attracted investment from established food companies. Last month, Switzerland's Bell Food Group agreed to put EUR5m in the Dutch business.

Beckie Calder-Flynn, Mosa Meat's operations co-ordinator, says: "We are aiming for a first market introduction in the next few years. It is very difficult to commit to a particular time frame because there are still some scientific unknowns and factors outside our control, such as the regulatory process.

"The first introduction will likely be small-scale. Several years beyond that, we aim to be widely available in supermarkets and restaurants."

The thorny issue of the cost of producing at scale is never far from the surface.

Calder-Flynn says: "As with any technology, initial prices tend to be extremely high until the product is commercialised, production is made efficient, and then products are sold en masse.

"For us, we are currently working on up-scaling our equipment so that we can produce large quantities quickly and efficiently. This hasn't been done before and is complex.

"We estimate that commercialisation will bring the price of a burger down to EUR9.00, compared with the EUR250,000 it cost to make the first burger. The cost of a hamburger in the supermarket is around EUR1.00 and we expect that with further efficiency improvements we will be able to bring the price down to this level over the next decade.

"Ultimately, cultured meat should be cheaper than conventional meat given its production is more efficient. One cell sample can create up to 10,000kg of cultured meat. Our estimates suggest that at that rate we would only need 150 cows to satisfy the world's current meat demand.

"The bottleneck currently is production efficiency and speed. It takes about ten weeks to make a [cell-based] hamburger, which is obviously not suitable for commercial production, but this doesn't mean we can't produce at industrial scale in the future. Because cell growth is exponential, it takes ten weeks to produce one quarter pound hamburger, but only about 12 weeks to produce 100,000 hamburgers."

Mosa Meat claimed another breakthrough on cost recently when the company announced it had achieved an 80x reduction in the cost of the growth medium or nutrient mix for its lab-grown meat.

Part of that transition is to move away from FBS (Fetal Bovine Serum), the standard growth medium used by the cell-based meat industry.

California-based New Age Meats is another business at the forefront of the cell-based charge. At the end of July, it secured $2m from investors just six months after raising $2.7m in seed funding from a consortium of backers.

The company said the new seed extension funding will help it to continue to develop cell-based pork products.

Specifically, New Age Meats plans to further expand its food science department, implement more automation and robotics and continue to attempt to reduce the cost of its first lab-produced product, a pork sausage.

Like its rivals, New Age Meats is now working towards building a pilot facility, scaling product development and production and getting its first foods to market.

Derin Alemli, director of operations and finance at the business, admitted development has slowed down because of the coronavirus pandemic.

"Covid has set the process back a little bit. We've been figuring out how to get back into the lab. We are at about 80% capacity now so we are making progress," he says.

Alemli believes the company's focus on pork gives it a distinct advantage. "Pigs are highly researched animals and there's a huge market for it. Our first product is a pork sausage because it's easier to use pork than a marbled product such as steak."

On the issue of cost, Alemli is optimistic about the future of lab-created products.

"The costs have come down dramatically to the $800-$1,000 a pound range," he says. "The equipment is expensive but that is a one-off cost. It's the media to feed the cells [that ratchets up costs]. "If we are not at the $15-$20 a pound range in the future that's tough sledding."

Also working hard to create lab-based meat is the French company Gourmey. The company is attempting to create a cruelty-free version of foie gras.

The French delicacy, which directly translates as "fat liver," is traditionally made out of the liver of a duck or goose which has been force-fed or over-fed.

Company co-founder and CEO Nicolas Morin-Forest tells just-food Gourmey is building a "versatile platform" around duck stem cells.

"With our cells' ability to specialise into any cell type, including muscle cells, we will also bring more complex cuts of meat at some point once the scaffold-based cultured meat technologies will have matured," he says.

Morin-Forest will not commit to a specific launch date at this stage.

"We are currently working on a lab-scale foie gras prototype and will showcase it in the next months," he says.

Jack Bobo, the CEO of Futurity, a Washington DC-based "food foresight company that helps brands get ahead of trends," is someone who has kept a close eye on developments in the cell-based area.

In terms of timescale for scaling up production, he says: "Some of the companies have got a very aggressive timeline. Others say they are some way off from commercialisation. Certainly there is some hype around businesses trying to get exposure to the media and investors. Companies with adequate funding are a lot less aggressive in what they are saying."

Bobo, a former special adviser on food policy at the US Department of State, suggests there are "some real technical issues that companies are still tackling".

He also thinks they can be communicating their message better. "I have talked privately to some of these companies and I told them to drop the term 'clean meat'. If I was running a company I would not want to be sitting down with a journalist and talking about safety and ethics.

"It's highly offensive to livestock producers and ended up with 28 states trying to stop them using the term meat. It was a self-inflicted wound. If you are getting close to market you need to communicate to the market better."

Of course, getting that product to market depends on regulatory approval and success ultimately depends retailers and consumers wanting to eat cell-based meat.

On the regulatory front, the US seems further ahead than Europe.

In March 2019, the Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced they'd established a framework for regulating cell-based meat and poultry.

The USDA will oversee food processing, labelling and distribution and the FDA will conduct inspections and safety checks. Within the European Union, food produced from cell culture or tissue culture derived from animals falls within the scope of the EU Novel Foods Regulation. There are those in cell-based meat space that see the US as having made more progress on the regulation of the fledgling sectorthan the EU, with some entrepreneurs wanting more engagement from Brussels and asking whether its process needs to take the time it does. The EU's Novel Foods Regulation takes up to two years in practice to go through.

Getting retailers and consumers on board is, of course, then also key once any approval is handed down.

Kay at Memphis Meats is confident in this regard. He says: "Research suggests that roughly two-thirds of Americans would eat cell-based meat, and that the more consumers learn about our products, the more enthusiastic they become.

"We are anticipating a lot of excitement from consumers, and we've already heard from many major retailers and restaurant chains that are interested in our work."

Calder-Flynn at Mosa Meat agrees. "We receive emails every day from people all around the world who are excited and passionate about cultured meat and the vast majority of responses we get about our work are extremely positive. People are wanting to eat healthier, more sustainable, and animal-friendly meat and they strongly believe cultured meat can offer that."

Alemli at New Age Meats says the research it has seen and done shows there will be early adopters if it is at the right cost. "The rise in alt-protein is good for us."

He suggest ethics and a post-Covid focus on safety will also come into play. "The inside of a slaughterhouse is not an appetising place. Our environment is very sanitary. It is safer, better for the environment."

When considering when such products will see the light of day, could the answer be in hybrid products, linking animal cells and plant-based ingredients?

Alemli at New Age Meats says his company's sausage is "more of a hybrid product", adding: "I think hybrid is a way of getting consumers ready for it and getting to market at a quite reasonable cost."

A company developing hybrid products is none other than KFC, the global fast-food chicken giant.

In July, KFC announced it had joined forces with Russian firm 3D Bioprinting Solutions, which is developing additive bioprinting technology that uses a recipe of chicken cells and plant ingredients. The resulting product is likely to be trialled in Russia.

What the move demonstrates is even mainstream majors are starting to think about the concept of cell-based meat and how it can benefit their businesses.

And while they can be accused of many things, being slow to market isn't one of them.

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A question of scale the growing pains of cell-based meat - just-food.com

Uncles incredible tribute to niece who died from the good cancer’ – Yahoo News Australia

By Stem Cell Doctors

An uncles poignant and loving tribute to his niece after she died following a seven-year battle with Hodgkin Lymphoma has led to life-saving stem cell and bone marrow donations.

Dr Melissa Baker, a single mum of two and forensic pathologist from Melbourne, died on January 16 - just two days after her 45th birthday.

In her memory, Melissas beloved uncle Max Tomlinson placed her photo and information about how to become a stem cell donor on his rear window in the hope of carrying on her hard work.

In memory of my beautiful niece Dr Melissa Baker. You can save a life, dont let Melissas be in vain. Order your swab kit now. Ideally men aged 18 to 45 with diverse backgrounds needed urgently. Order your kit now urthecure.com.au, it reads in white marker pen.

Melissas beloved uncle, Max Tomlinson, placed her photo and information about how to become a stem cell donor on his car's rear window. Source: Facebook

Melissas sister, Jenni Baker, recently posted a picture of Mr Tomlinsons car on Facebook while thanking a member of the public who tucked a yellow flower under his windshield wiper.

Melissa, whos kids are 13 and 8, waited for a bone marrow match for years after an initial six-month round of chemotherapy didnt work, Jenni, a Melbourne police officer, told Yahoo News Australia on Friday.

She underwent a bone marrow transplant using her own stem cells but it almost killed her when she developed a lung infection, her sister said.

Doctors told the 45-year-old, who had since developed cancer of the bone marrow as a result of the chemotherapy, she desperately needed a donor and so she began advocating for UR The Cure.

The volunteer-run charity works with the Australian Bone Marrow Donor Registry (ABMDR) to increase the number of donors especially middle-aged people of diverse backgrounds.

Melissa, whos kids are 13 and 8, waited for a bone marrow match for years after an initial six-month round of chemotherapy didnt work. Source: Facebook

Reluctantly, in November 2019, she underwent a more risky half-match stem cell transplant where I was her donor, Jenni said.

The odds werent great but she had no choice.

Tragically, after 58 days in the hospital, most of which she spent on a ventilator, Melissa died on January 16.

Jennis Facebook post about her uncles tribute has garnered more than 2,500 likes and hundreds of comments, many of which are people who said they had since signed up to be a stem cell donor.

I was a bone marrow donor for my dad. Unfortunately he passed just four months after the donation. I would do it again in a heartbeat for anyone who needed it, one woman wrote.

Beautiful! Tell your uncle I just ordered my kit! another said.

A woman named Amanda also commented, revealing she had been one of Melissas nurses.

I dont know if you remember me. I am one of the nurses who took care of your sister in the ICU. I always admired how much support Melissa had from you and your sister. Her life is definitely not in vain and the love she had from you all was so strong, she wrote.

Melissa Baker underwent a bone marrow transplant using her own stem cells but it almost killed her when she developed a lung infection. Source: Facebook

Story continues

Jenni said Melissa never thought in her wildest dreams this would happen and had at one point thought the cancer would be a battle she would have to fight throughout her life.

The 47-year-old police officer told Yahoo News Australia Melissa became upset when she was often told she had the good cancer because of Hodgkins higher success rate.

She was so mad about it she even made a blog called I Got the Good Cancer documenting her struggles and treatments.

And then everything bad that could have happened, happened, Jenni said.

Jenni (right) and Melissa (left) are pictured together in front of Parliament House. Source: Facebook

The mum-of-two spent last Christmas intubated and sedated in hospital but was able to squeeze her childrens hands when they came to visit.

When the tubes came out on Boxing Day, Melissa mumbled to Jenni, Im scared. This is really scary.

They were the last words Melissa said.

Just two days later Melissa was ventilated again until the tubes were removed on January 14 - her birthday - after deciding it was too cruel.

Fifty-two hours later she passed surrounded by her parents, siblings and children.

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Uncles incredible tribute to niece who died from the good cancer' - Yahoo News Australia

Stem Cell Therapy Market Landscape Assessment By Type and Analysis Current Trends by Forecast To 2025 – The Daily Chronicle

By Embryonic Stem Cells

Global Stem Cell Therapy Market: Overview

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

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

Know the Growth Opportunities in Emerging Markets

Global Stem Cell Therapy Market: Key Trends

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

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

Global Stem Cell Therapy Market: Market Potential

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

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

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

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

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

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

Global Stem Cell Therapy Market: Competitive Analysis

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

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

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Stem Cell Therapy Market Landscape Assessment By Type and Analysis Current Trends by Forecast To 2025 - The Daily Chronicle

Stem Cell Therapy Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 – Bulletin Line

By Embryonic Stem Cells

Allosource

The market is further segmented on the basis of types and end-user applications. The report also provides an estimation of the segment expected to lead the market in the forecast years. Detailed segmentation of the market based on types and applications along with historical data and forecast estimation is offered in the report.

Furthermore, the report provides an extensive analysis of the regional segmentation of the market. The regional analysis covers product development, sales, consumption trends, regional market share, and size in each region. The market analysis segment covers forecast estimation of the market share and size in the key geographical regions.

The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.

1.Stem Cell Therapy Market, By Cell Source:

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

2.Stem Cell Therapy Market, By Therapeutic Application:

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

On the basis of regional segmentation, the market is bifurcated into major regions ofNorth America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.The regional analysis further covers country-wise bifurcation of the market and key players.

The research report offered by Verified Market Research provides an updated insight into the global Stem Cell Therapy market. The report covers an in-depth analysis of the key trends and emerging drivers of the market likely to influence industry growth. Additionally, the report covers market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market.

Highlights of the TOC of the Stem Cell Therapy Report:

Overview of the Global Stem Cell Therapy Market

Market competition by Players and Manufacturers

Competitive landscape

Production, revenue estimation by types and applications

Regional analysis

Industry chain analysis

Global Stem Cell Therapy market forecast estimation

This Stem Cell Therapy report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.

Key Questions Addressed in the Report:

What are the key driving and restraining factors of the global Stem Cell Therapy market?

What is the concentration of the market, and is it fragmented or highly concentrated?

What are the major challenges and risks the companies will have to face in the market?

Which segment and region are expected to dominate the market in the forecast period?

What are the latest and emerging trends of the Stem Cell Therapy market?

What is the expected growth rate of the Stem Cell Therapy market in the forecast period?

What are the strategic business plans and steps were taken by key competitors?

Which product type or application segment is expected to grow at a significant rate during the forecast period?

What are the factors restraining the growth of the Stem Cell Therapy market?

Thank you for reading our report. The report is available for customization based on chapters or regions. Please get in touch with us to know more about customization options, and our team will ensure you get the report tailored according to your requirements.

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Stem Cell Therapy Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 - Bulletin Line

Pluristem and Abu Dhabi Stem Cells Center Sign MOU to Collaborate in the Development of Cell Therapies and Regenerative Medicines for the Treatment of…

By Stem Cell Treatment

August 17, 2020 02:00 ET | Source: Pluristem Therapeutics, Inc.

HAIFA, Israel, Aug. 17, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today its subsidiary, Pluristem Ltd., has signed a non-binding Memorandum of Understanding (MOU) with the United Arab Emirates-based Abu Dhabi Stem Cells Center (ADSCC), a specialist healthcare center focused on cell therapy and regenerative medicine. Executives from both companies took part in a signing ceremony held via video conference between Israel and the UAE. The aim of the collaboration is to capitalize on each companys respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel, but for humanity as a whole. The collaboration between the parties was initiated by the Better Alternatives advisory firm.

The parties have agreed to exchange research results, share samples, join usage of equipment and testing, and other essential activities related to advancing the treatment and research of cell therapies for a broad range of medical conditions, including COVID-19.

ADSCC has been treating COVID-19 patients with stem cells sourced from the patients blood, by returning the cells back into the patients lungs as a fine mist through a nebulizer, a machine that helps a patient breathe in medicine through a mask or mouthpiece. Pluristem has treated patients with its placental PLX-PAD allogenic product via compassionate use programs in Israel and the U.S. and is currently conducting phase II studies in the U.S. and EU.

We are extremely proud to partner with our colleagues at the ADSCC by sharing knowledge and expertise that we believe will advance healthcare within and across our borders. We see life science and regenerative medicine as a bridge for building peace, prosperity, and well-being in our region and for the entire world. I believe it is our obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education. We are honored to be on the front line of this historical moment, stated Pluristem CEO and President Yaky Yanay.

Dr Yendry Ventura, General Manager of the ADSCC commented, Pluristem is a major player in the cell therapy field with years of experience, a unique platform and a robust clinical pipeline. We are excited to join forces and to promote the research and development of cell therapies for the best of the patients and the human society as a whole.

About Abu Dhabi Stem Cells Center Abu Dhabi Stem Cells Center (ADSCC) is an Abu Dhabi-based specialist healthcare center focused on cell therapy and regenerative medicine, as well as delivering cutting-edge research on stem cells in the region. The Center was founded in March 2019 to meet growing domestic and regional demand for highly specialized medical services and treatments. Equipped with the latest technologies, medical devices which are unique to the region, and a team of internationally recognized doctors working hand in hand with researchers, ADSCC is the first of its kind in the UAE. ADSCC specialties include immunology, hematology, clinical stem cell therapy, molecular biology, immunotherapy, orthopedics, and urology amongst others.

About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the aim of the collaboration with the ADSCC is to capitalize on each companys respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel, but for humanity as a whole and the belief that it is its obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana Rubin Director of Investor Relations 972-74-7107194 danar@pluristem.com

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Pluristem and Abu Dhabi Stem Cells Center Sign MOU to Collaborate in the Development of Cell Therapies and Regenerative Medicines for the Treatment of...

Brevard Zoo’s Bear ‘Brody’ Received Radiographs and Underwent First Round of Stem-Cell Therapy – SpaceCoastDaily.com

By Stem Cell Treatment

Two injections containing about five million stem cells delivered directly to Brodys hip joints During last months surgery to address an issue with Brodys joints, Dr. Jeffrey Christiansen of Superior Veterinary Surgical Solutions collected a small amount of Brodys fat. (Brevard Zoo image)

BREVARD COUNTY MELBOURNE, FLORIDA During last months surgery to address an issue with Brodys joints, Dr. Jeffrey Christiansen of Superior Veterinary Surgical Solutions collected a small amount of Brodys fat.

A laboratory extracted stem cells from the fat sample, which can be used to reduce pain and inflammation and promote healing of the surgical site.

On Friday morning, Brody was brought back to the L3Harris Animal Care Center to receive his first dose of this medication.

Two injections containing about five million stem cells each were delivered directly to Brodys hip joints. To accomplish this, Dr. Christiansen carefully inserted a needle into Brodys hip and drew a small amount of joint fluid to confirm the tip was in the right place, then administered the injection.

A third, less-concentrated injection was delivered intravenously.

We also captured some radiographs to check on Brodys hip condition.

While we wont be able to evaluate the long-term effectiveness of the surgery for quite some time, he appears to be recovering without complication.

Brody woke from the anesthesia and was returned to his habitat. It is normal for animals to experience discomfort and lameness for a few days following stem-cell injections, but Brody is already back to being his normal, energetic self.

We have enough stem cells banked for an additional 15 doses, which will be administered throughout the course of Brodys life as needed.

Quality veterinary care is expensive. Click here to support animal wellness at the Zoo during this financially challenging time.

CLICK HERE FOR BREVARD COUNTY NEWS

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Brevard Zoo's Bear 'Brody' Received Radiographs and Underwent First Round of Stem-Cell Therapy - SpaceCoastDaily.com

Gene targeting helps overcome the resistance of brain cancer to therapy – McGill Newsroom

By Stem Cell Treatment

New insight into a gene that controls energy production in cancer stem cells could help in the search for a more effective treatment for glioblastoma. A McGill-led study published in Nature Communications reveals that suppressing the OSMR gene can improve the effectiveness of radiation therapy.

This approach, led by the laboratory of Arezu Jahani-Asl, Assistant Professor of Medicine at McGill University, was successful in preclinical mouse models where the deletion of the OSMR gene resulted in a significant improvement of tumour response to therapy and expanded lifespan.

Glioblastoma is the most common and aggressive cancerous brain tumour in adults due to its resistance to therapy. Treatment usually involves surgery, followed by chemotherapy and radiation therapy. Despite these intensive efforts, in most cases tumour cells regrow after treatment and the cancer recurs.

Starving cancer stem cells

Glioblastoma tumours contain rare cancer stem cells responsible for therapeutic resistance and tumour regrowth. In the study, researchers uncover the unique role OSMR plays in fortifying cancer stem cells resistance to therapy by strengthening mitochondria, the powerhouse of cell energy production. It makes the long journey to the mitochondria and interacts with energy-producing machineries to force them to generate more energy for cancer cells.

To improve patient response to glioblastoma treatment, we must find new vulnerabilities in cancer stem cells and overcome their resistance to therapy. By suppressing OSMR, we were able to halt energy production in cancer stem cells, essentially starving them to death, says Jahani-Asl.

The study provides evidence that targeting OSMR gene, in combination with radiation therapy, can pave the way for future clinical trials that better treat glioblastoma tumours. The next step is to leverage these tools into a clinical trial, the researchers say.

About the study

OSMR controls glioma stem cell respiration and confers resistance of glioblastoma to ionizing radiation by Ahmad Sharanek, Audrey Burban, Matthew Laaper, Emilie Heckel, Jean-Sebastien Joyal, Vahab D. Soleimani, and Arezu Jahani-Asl is published in Nature Communications. The study was supported by CIHR and The Brain Tumor Charity.

DOI: http://dx.doi.org/10.1038/s41467-020-17885-z

About McGill University

Founded in Montreal, Quebec, in 1821, McGill University is Canadas top ranked medical doctoral university. McGill is consistently ranked as one of the top universities, both nationally and internationally. Itis a world-renownedinstitution of higher learning with research activities spanning two campuses, 11 faculties, 13 professional schools, 300 programs of study and over 40,000 students, including more than 10,200 graduate students. McGill attracts students from over 150 countries around the world, its 12,800 international students making up 31% of the student body. Over half of McGill students claim a first language other than English, including approximately 19% of our students who say French is their mother tongue.

http://www.mcgill.ca/newsroom/ http://twitter.com/McGillU

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Gene targeting helps overcome the resistance of brain cancer to therapy - McGill Newsroom

bluebird bio to Present New Data from Clinical Studies of elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for Cerebral Adrenoleukodystrophy…

By Stem Cell Treatment

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that new data from the clinical development program for its investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including data from the Phase 2/3 Starbeam study (ALD-102) and available data from the Phase 3 ALD-104 study, will be presented at the 46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2020), taking place virtually from August 29 - September 1, 2020.

New Cerebral Adrenoleukodystrophy (CALD) Data at EBMT 2020

Lenti-D hematopoietic stem cell gene therapy stabilizes neurologic function in boys with cerebral adrenoleukodystrophy (ALD-102 and ALD-104) Presenting Author: Dr. Jrn-Sven Khl, Department of Pediatric Oncology, Hematology and Hemostaseology, Center for Womens and Childrens Medicine, University Hospital Leipzig Poster Session & Number: Gene Therapy; ePoster O077

Additional bluebird bio data at EBMT 2020 includes encore presentations from the companys CALD, sickle cell disease (SCD), transfusion-dependent -thalassemia (TDT) and multiple myeloma programs.

Cerebral Adrenoleukodystrophy (CALD) Encore Data at EBMT 2020

Outcomes of allogeneic hematopoietic stem cell transplant in patients with cerebral adrenoleukodystrophy vary by donor cell source, conditioning regimen, and stage of cerebral disease status (ALD-103) Presenting Author: Dr. Jaap Jan Boelens, Chief, Pediatric Stem Cell Transplantation and Cellular Therapies Service, Memorial Sloan Kettering Cancer Center Poster Session & Number: Haemoglobinopathy and inborn errors; ePoster O106

Multiple Myeloma Correlative Encore Data at EBMT 2020

Markers of initial and long-term responses to idecabtagene vicleucel (ide-cel; bb2121) in the CRB-401 study in relapsed/refractory multiple myeloma Presenting Author: Dr. Ethan G. Thompson, Bristol Myers Squibb Poster Session & Number: CAR-based Cellular Therapy clinical; ePoster A089

Sickle Cell Disease (SCD) Encore Data at EBMT 2020

LentiGlobin for sickle cell disease (SCD) gene therapy (GT): updated results in Group C patients from the Phase 1/2 HGB-206 study Presenting Author: Dr. Markus Y. Mapara, Director, Adult Blood and Marrow Transplantation Program, Columbia University Medical Center Oral Session & Number: Inborn Errors; O080 Date & Time: September 1, 2020; 4:35 4:42 PM CET/10:35 10:42 AM ET

Transfusion-Dependent -Thalassemia (TDT) Encore Data at EBMT 2020

Clinical outcomes following autologous hematopoietic stem cell transplantation with LentiGlobin gene therapy in the Phase 3 Northstar-2 and Northstar-3 studies for transfusion-dependent -thalassemia Presenting Author: Professor Franco Locatelli, Director, Department of Pediatric Hematology and Oncology, Ospedale Pediatrico Bambino Ges Poster Session & Number: Gene Therapy; ePoster O074

LentiGlobin gene therapy treatment of two patients with transfusion-dependent -thalassemia (case report) Presenting Author: Dr. Mattia Algeri, Department of Pediatric Oncohematology - Transplantation Unit and Cell Therapies, Ospedale Pediatrico Bambino Ges Poster Session & Number: Haemoglobinopathy and inborn errors; ePoster A328

Cross Indication Encore Data at EBMT 2020

Safety of autologous hematopoietic stem cell transplantation with gene addition therapy for transfusion-dependent -thalassemia, sickle cell disease, and cerebral adrenoleukodystrophy Presenting Author: Dr. Evangelia Yannaki, Director, Gene and Cell Therapy Center, Hematology Department, George Papanicolaou Hospital Poster Session & Number: Gene Therapy; ePoster O078

Abstracts outlining bluebird bios accepted data at EBMT 2020 are available on the Annual Meeting website. On August 29, 2020, at 12:30 PM CET/6:30 AM ET, the embargo will lift for ePosters and oral presentations accepted for EBMT 2020. Presentations will be available for virtual viewing throughout the duration of the live meeting and content will be accessible online following the close of the meeting until November 1, 2020.

About elivaldogene autotemcel (eli-cel, Lenti-D gene therapy) In July 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted an accelerated assessment to eli-cel gene therapy for cerebral adrenoleukodystrophy (CALD). bluebird bio is currently on track to submit the Marketing Authorization Application (MAA) in the EU for eli-cel for CALD by year-end 2020, and the Biologics License Application (BLA) in the U.S. in mid-2021.

bluebird bio is currently enrolling patients for a Phase 3 study (ALD-104) designed to assess the efficacy and safety of eli-cel after myeloablative conditioning using busulfan and fludarabine in patients with CALD. Contact clinicaltrials@bluebirdbio.com for more information and a list of study sites.

Additionally, bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-304) for patients who have been treated with eli-cel for CALD and completed two years of follow-up in bluebird bio-sponsored studies.

The Phase 2/3 Starbeam study (ALD-102) has completed enrollment. For more information about the ALD-102 study visit: http://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT01896102.

Adrenoleukodystrophy (ALD) is a rare, X-linked metabolic disorder that is estimated to affect one in 21,000 male newborns worldwide. Approximately 40 percent of boys with ALD will develop CALD, the most severe form of ALD. CALD is a progressive neurogenerative disease that involves breakdown of myelin, the protective sheath of the nerve cells in the brain that are responsible for thinking and muscle control. Symptoms of CALD usually occur in early childhood and progress rapidly, if untreated, leading to severe loss of neurologic function, and eventual death, in most patients.

The European Medicines Agency (EMA) accepted eli-cel gene therapy for the treatment of CALD into its Priorities Medicines scheme (PRIME) in July 2018, and previously granted Orphan Medicinal Product designation to eli-cel.

The U.S. Food and Drug Administration (FDA) granted eli-cel Orphan Drug status, Rare Pediatric Disease designation, and Breakthrough Therapy designation for the treatment of CALD.

Eli-cel is not approved for any indication in any geography.

About idecabtagene vicleucel (ide-cel; bb2121) Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3- chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

In addition to the pivotal KarMMa trial evaluating ide-cel in patients with relapsed and refractory multiple myeloma, bluebird bio and Bristol Myers Squibbs broad clinical development program for ide-cel includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4) in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.

In July 2020, Bristol Myers Squibb (BMS) and bluebird bio submitted the Biologics License Application for ide-cel to the U.S. Food and Drug Administration for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Ide-cel is the first CAR T cell therapy submitted for regulatory review to target BCMA and for multiple myeloma.

Ide-cel was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority Medicines (PRIME) designation, as well as Accelerated Assessment status, by the European Medicines Agency for relapsed and refractory multiple myeloma.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between BMS and bluebird bio.

Ide-cel is not approved for any indication in any geography.

About LentiGlobin for Sickle Cell Disease LentiGlobin for sickle cell disease (SCD) is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bios clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study and the ongoing Phase 3 HGB-210 study.

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel and LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS). HbS causes red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive crises (VOCs). For adults and children living with SCD, this means painful crises and other life-altering or life-threatening acute complicationssuch as acute chest syndrome (ACS), stroke and infections. If patients survive the acute complications, vasculopathy and end-organ damage, resulting complications can lead to pulmonary hypertension, renal failure and early death; in the U.S. the median age of death for someone with sickle cell disease is 43 - 46 years.

LentiGlobin for SCD received Orphan Medicinal Product designation from the European Commission for the treatment of SCD.

The U.S. Food and Drug Administration (FDA) granted Orphan Drug status and Regenerative Medicine Advanced Therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin for the treatment of SCD.

bluebird bio reached general agreement with the U.S. Food and Drug Administration (FDA) that the clinical data package required to support a Biologics Licensing Application (BLA) submission for LentiGlobin for SCD will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. The planned submission will be based on an analysis using complete resolution of severe vaso-occlusive events (VOEs) as the primary endpoint with at least 18 months of follow-up post-treatment with LentiGlobin for SCD. Globin response will be used as a key secondary endpoint.

bluebird bio anticipates additional guidance from the FDA regarding the commercial manufacturing process, including suspension lentiviral vector. bluebird bio announced in a May 11, 2020 press release it plans to seek an accelerated approval and expects to submit the U.S. BLA for SCD in the second half of 2021.

LentiGlobin for SCD is investigational and has not been approved in any geography.

About betibeglogene autotemcel (beti-cel; formerly LentiGlobin gene therapy for -thalassemia) The European Commission granted conditional marketing authorization (CMA) for betibeglogene autotemcel, marketed as ZYNTEGLO gene therapy, for patients 12 years and older with transfusion-dependent -thalassemia (TDT) who do not have a 0/0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate, but a human leukocyte antigen (HLA)-matched related HSC donor is not available. On April 28, 2020, the European Medicines Agency (EMA) renewed the CMA for ZYNTEGLO, supported by data from 32 patients treated with ZYNTEGLO, including three patients with up to five years of follow-up.

In the HGB-207 clinical study supporting the conditional marketing approval of ZYNTEGLO, the primary endpoint was transfusion independence (TI) by Month 24, defined as a weighted average Hb 9 g/Dl without any RBC transfusions for a continuous period of 12 months at any time during the study after infusion of ZYNTEGLO. Ten patients were evaluable for assessment of TI. Of these, 9/10 (90.0%, 95% CI 55.5-99.7%) achieved TI at last follow-up. Among these nine patients, the median (min, max) weighted average Hb during TI was 12.22 (11.4, 12.8) g/dLl.

TDT is a severe genetic disease caused by mutations in the -globin gene that result in reduced or significantly reduced hemoglobin (Hb). In order to survive, people with TDT maintain Hb levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

Beti-cel adds functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once a patient has the A-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived hemoglobin, at levels that may eliminate or significantly reduce the need for transfusions.

Non-serious adverse events (AEs) observed during the clinical studies that were attributed to betibeglogene autotemcel included abdominal pain, thrombocytopenia, leukopenia, neutropenia, hot flush, dyspnoea, pain in extremity, and non-cardiac chest pain. Two serious adverse events (SAE) of thrombocytopenia were considered possibly related to beti-cel.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.

The CMA for beti-cel is valid in the 27 member states of the EU as well as UK, Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).

The U.S. Food and Drug Administration granted beti-cel Orphan Drug status and Breakthrough Therapy designation for the treatment of TDT. Beti-cel is not approved in the United States.

Beti-cel continues to be evaluated in the ongoing Phase 3 Northstar-2 and Northstar-3 studies. For more information about the ongoing clinical studies, visit http://www.northstarclinicalstudies.com or clinicaltrials.gov and use identifier NCT02906202 for Northstar-2 (HGB-207), NCT03207009 for Northstar-3 (HGB-212).

About bluebird bio, Inc. bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

Lenti-D and bluebird bio are trademarks of bluebird bio, Inc.

Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the companys financial condition, results of operations, as well as statements regarding the plans for regulatory submissions for beti-cel (marketed as ZYTENGLO in the European Union), eli-cel, ide-cel, and LentiGlobin for SCD, including anticipated endpoints to support regulatory submissions and timing expectations; the companys expectations regarding the potential for the suspension manufacturing process for lentiviral vector; its expectations for commercialization efforts for ZYNTEGLO in Europe; as well as the companys intentions regarding the timing for providing further updates on the development and commercialization of ZYNTEGLO and the companys product candidates. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the COVID-19 pandemic and resulting economic conditions will have a greater impact on the companys operations and plans than anticipated; that our amended collaboration with BMS will not continue or be successful; that preliminary positive efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in our ongoing or future clinical trials; the risk that our plans for submitting a BLA for LentiGlobin for SCD may be delayed if the FDA does not accept our comparability plans for the use of the suspension manufacturing process for lentiviral vector; the risk that the submission of BLA for ide-cel is not accepted for filing by the FDA or approved in the timeline we expect, or at all; the risk of cessation or delay of any of the ongoing or planned clinical studies and/or our development of our product candidates, including due to delays from the COVID-19 pandemics impact on healthcare systems; the risk that the current or planned clinical trials of our product candidates will be insufficient to support regulatory submissions or marketing approval in the United States and European Union; the risk that regulatory authorities will require additional information regarding our product candidates, resulting in delay to our anticipated timelines for regulatory submissions, including our applications for marketing approval; the risk that we will encounter challenges in the commercial launch of ZYNTEGLO in the European Union, including in managing our complex supply chain for the delivery of drug product, in the adoption of value-based payment models, or in obtaining sufficient coverage or reimbursement for our products; and the risk that any one or more of our product candidates, will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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bluebird bio to Present New Data from Clinical Studies of elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for Cerebral Adrenoleukodystrophy...

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