Google relaxes ban on stem cell therapy ads – The Verge

Google will allow ads for stem cell treatments that are approved by the US Food and Drug Administration a change from its previous policy, which banned all ads for this experimental category of medical care. The policy update was first reported by Gizmodo and will go into effect in July.

The company said in the policy update that it will also allow cell or gene therapy ads that are exclusively educational or informational in nature, even if they reference products or applications that are not approved by the FDA. Its not clear how Google would define educational or informational or what type of advertisements would be allowed under that umbrella.

Stem cell therapy is a broad term for medical treatments that use stem cells, which can develop into any cell type. There are some evidence-based applications for the cells, like to treat some cancers, and there are around two dozen FDA-approved cell- and gene-therapy products (which Googles new policy would allow ads for).

But most uses for stem cells are unproven, experimental, and can be dangerous. Clinics claim the cells, taken from donated umbilical cords or from patients fat, can treat things like joint pain or eye conditions. People have developed infections and died after getting those types of procedures. The FDA has tried to crack down on businesses offering these types of procedures, but theyve proliferated over the past few years.

Googles initial ban on stem cell ads hasnt done much to keep the clinics from popping up in search, Paul Knoepfler, a professor at the UC Davis School of Medicine, wrote in Stat in March. Even if they cant advertise, the companies have designed websites that appear at the top of search results for searches related to stem cells above more reputable medical resources, like the National Institutes of Health.

These companies are savvy and have been able to skirt policies to push out their products even in the face of a total ban. Now, that ban is set to relax, opening up new avenues for groups to distribute information. Googles continuing stem cell problem is emblematic of a serious, broader problem with unproven biomedical offerings the company needs to address, Knoepfler wrote.

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Google relaxes ban on stem cell therapy ads - The Verge

CU Anschutz center for cell-based therapy gets $200 million expansion – The Denver Post

An existing center on the University of Colorados Anschutz Medical Campus that helps develop treatments based on patients own cells is getting a $200 million boost, with the hope of getting those treatments to the public faster.

Chancellor Don Elliman said the Anschutz campus and the Gates Frontiers Fund will each invest $20 million per year over the next five years to turn the existing Gates Center for Regenerative Medicine into the significantly larger Gates Institute.

The Gates Frontiers Fund is affiliated with the Gates Family Foundation, a Colorado-based nonprofit,and is not connected to Bill Gates foundation.

The fund and the campus in Aurora also have partnered on a manufacturing facility that reprograms patients immune cells to fight certain cancers. Elliman said they dont expect to need a new building for the institutes expanded work.

Regenerative medicine is a broad term for treatments that try to harness the bodys ability to fix itself. That could involve reprogramming cells to replace dying tissue or fight cancer, or therapies that insert a healthy gene to replace a defective version thats causing disease.

Its early enough in the process that the institutes leadership hasnt chosen specific focus areas under the regenerative medicine umbrella.

Most of the $200 million will go toward hiring scientists, as well as support personnel to help both the new researchers and those already working on campus, Elliman said.

Once the institute is up and running, it will bring in new federal grants to support research and investment from biotech firms that can bring the treatments to market, he said.

This investment is really a seed investment, he said.

Dr. Terry Fry, the institutes executive director, said its meant to help scientists with ideas that show promise in the lab to take the steps toward testing them in humans.

The process of manufacturing treatments and getting trials approved is more complex for biologic therapies than for standard drugs, he said.

Theres a stage in the development of that sort of project where investigator-scientists run up against a brick wall, he said. A lot of the role that I see the institute playing is removing those barriers.

Fry, a pediatric oncologist, was one of the first researchers who worked on chimeric antigen receptor T-cell (CAR-T) therapy the immune cell reprogramming therapy. It was approved first for children with leukemia, but now is also used for adults and for other blood cancers, like lymphoma and myeloma. He declined to name specific projects the institute would work on, but said potential improvements to CAR-T could be within its scope.

The therapy takes a kind of T-cell that kills cells infected with viruses or bacteria, and gets it to attack cancerous cells instead. While it has improved survival for people with certain blood cancers, it doesnt work well against solid tumors at this point. It also requires taking T-cells from each patient to produce their own treatment, which is expensive and slows down the process. Researchers are working on how to make CAR-T work for more people, and to create an off the shelf option, Fry said.

Another general area the institute could work on is growing cells to replace ones that have died or are defective, Fry said. Much of that work involves adult stem cells that have been coaxed back into an earlier form, when they could become almost any type of cell under the right conditions.

For example, if the stem cells can be primed to turn into cells producing insulin, that could help patients with Type 1 diabetes, which is caused when the insulin-producers die, he said.

It is really remarkable technology, he said.

The institute wont take down every hurdle to bringing new treatments to patients, Fry said. Manufacturing and distributing at a large scale will require partnerships with biotech firms, which fortunately are setting up in the Denver area in increasing numbers, he said.

I think this is the right time and exactly the right part of the country for this type of institute, he said.

Diane Gates Wallach, one of the Gates funds co-trustees, said the new institute will further her fathers goal of speeding up the process of getting new discoveries into clinical practice, so patients can benefit. Since the Anschutz campus includes researchers and two hospitals, it made sense to invest there, she said in a news release.

It takes a dynamic, innovative medical ecosystem for an institute like this to thrive and be successful, she said.

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CU Anschutz center for cell-based therapy gets $200 million expansion - The Denver Post

$83 Bn Regenerative Medicine Markets – Global Opportunity Analysis and Industry Forecast, 2021-2022 & 2030 – ResearchAndMarkets.com – Business…

DUBLIN--(BUSINESS WIRE)--The "Regenerative Medicine Market by Product Type, Material, Application and End user (Hospitals, Ambulatory Surgical Centers, and Others: Global Opportunity Analysis and Industry Forecast, 2021-2030" report has been added to ResearchAndMarkets.com's offering.

The regenerative medicine market size was valued at $10,107.32 million in 2020, and is estimated to reach $83,196.72 million by 2030, growing at a CAGR of 23.4% from 2021 to 2030.

Regenerative medicine is a process of replacing human cells, tissues or organs to restore or establish normal function. It is field that brings together experts in biology, chemistry, genetics and medicine. This is a promising field which working to restore structure and function of damaged tissues and organs.

It includes cell therapy involves the use of cellular materials such as stem cells, autologous cells, xenogeneic cells, and others, for the therapeutic treatment of patients. Cell therapy is used to replace damaged cells, deliver therapies to target tissues/organs, stimulate self-healing, and various other applications in regenerative medicine.

The major factors boosting the regenerative medicine market growth include technological advancements in tissue and organ regeneration, increase in prevalence of chronic diseases and trauma emergencies, prominent potential of nanotechnology, and emergence of stem cell technology.

In addition, increase in incidence of degenerative diseases and shortage of organs for transplantation are expected to boost the growth of the market. The prominent potential of regenerative medicine to replace, repair, and regenerate damaged tissues and organs has fueled the market growth. In addition, technological advancements in regenerative medicine production and advancement in the stem cell therapy procedures propel the growth of the market.

Rise in prevalence of musculoskeletal diseases and increase in dermatological treatments propel the growth of the market. Moreover, utilization of nanomaterial's in wound care, drug delivery, and immunomodulation has opened growth avenues for the regenerative medicine market.

However, stringent regulations, operational inefficiency, and high cost of regenerative medicine treatment are key factors that hinder the market growth. Furthermore, advancements in stem cell technology and increase in R&D activities in the emerging economies are expected to fuel the market growth during the forecast period. Developed nations have adopted technological advancements in tissue engineering and regenerative medicine sectors, which help in the expansion of the global market.

Moreover, rise in development of pharmaceutical and medical device industries and improvement in healthcare spending are anticipated to drive the growth of the regenerative medicine market. In addition, increase in demand for regenerative medicine led to development of innovative technologies in the healthcare sector, thereby propelling growth of the market.

Moreover, initiatives taken by governments for development of advanced stem cell therapies and development of the healthcare sector for manufacturing of regenerative medicine are the key factors that boost growth of the market. Furthermore, surge in geriatric population, who are more vulnerable to chronic disease, propels the market growth.

KEY MARKET PLAYERS

KEY MARKET SEGMENTS

By Product Type

By Material

By Application

By End User

By Region

For more information about this report visit https://www.researchandmarkets.com/r/qek5u

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Cord Blood Banking: Benefits, Cost, and Process – Healthline

If you are a new or expectant parent, youve probably heard about the option of banking your babys cord blood at birth. The topic can be confusing, and you may have many unanswered questions.

You may be unsure exactly what cord banking involves, why people choose to bank their infants blood, whether its worth it to do so, and how much it costs to bank cord blood.

Heres a simple breakdown of the potential benefits of cord blood banking and how to decide if its right for your family.

At birth, your newborns placenta and umbilical cord contain blood that is rich with potentially lifesaving stem cells. This blood can be removed, stored, and used down the road to treat various diseases and conditions.

Healthcare professionals do not remove cord blood directly from babies or birthing parents. Rather, it comes from the umbilical cord and placenta themselves, according to the American College of Obstetricians and Gynecologists (ACOG).

The stem cells in umbilical cords and placentas are called hematopoietic stem cells. In people with certain health conditions, they can be used to produce healthy new cells and replace damaged cells.

Stem cells are used to treat over 70 types of diseases, according to ACOG. These include:

You might choose to bank your newborns cord blood for several reasons.

First, you may choose to do so if you have a family member with a medical condition that might benefit from stem cell donation. Alternatively, you might want to donate your babys blood to help another person in need of stem cells.

One myth about cord banking is that you child can use the cord blood down the line, should they develop a serious medical concern. This type of transfer where a persons own cord blood is used to treat their health condition is called an autologous transplant.

ACOG notes that autologous transfers are rare.

If your child has a genetic disease, for example, treating them with their own stem cells wouldnt help because these stem cells contain the same genes as the cells that are involved in the disease. Similarly, your own childs stem cells cant be used to treat cancers such as leukemia.

Instead, most cord blood transplants are allogeneic.

This means that your childs stem cells would be used to treat another child or adult. It would require a strong match between the stem cell recipient (the person using the stem cells) and the stem cell donor (your child).

The benefits of cord blood banking depend on your purpose and where you are storing your childs cord blood.

If you are storing your childs blood at a private institution, you may be able to use the stem cells to directly benefit a family member in need, including a close family member or your childs sibling.

Storing your babys cord blood in a public facility has benefits, too. Stem cells can help treat people with many types of health conditions, including cancers and certain metabolic and immunologic conditions, according to the Health Resources & Services Administration.

There are many advantages to using stem cell transplants for treating medical conditions rather than using bone marrow transplants.

According to ACOG, these benefits include:

If you want to have your newborns cord blood collected, you should inform your OB-GYN or birthing professional, such as a midwife, and the hospital or facility where you will give birth. They may need to order special equipment or a cord collecting kit.

Usually, you will need to inform your healthcare team of your choice to bank your infants blood about 6 weeks in advance of your due date. Youll also need to be sure youve signed all the required consent forms.

Cord blood extraction happens in the hospital after birth and after a healthcare professional has clamped and cut the umbilical cord. They will then use a needle to draw blood out of the cord and store in a designated bag.

The entire process is quick about 10 minutes and does not involve direct contact with your baby.

Sometimes, cord blood extraction isnt possible. Reasons for this may include:

After collection, cord blood must be stored very carefully to ensure that its quality is preserved. Each facility has its own protocols and procedures for how this is done.

The Academy of American Pediatrics (AAP) explains certain accrediting institutions oversee the regulation of cord blood storage and cautions that some private cord blood banks may not meet all these standards.

Before agreeing to have your childs cord blood stored at a private facility, you may want to find out:

Cord blood bank accrediting institutions include:

Before considering cord blood donation, its important for you to understand the difference between private and public banks. Heres what to know:

Private banks are usually used by parents who believe that their childs cord blood may be helpful to a family member who has a medical condition.

They require you to pay on an ongoing basis for your childs cord blood to be stored.

Not all private banks are accredited or regulated in the same way that public banks are.

Public banks are free and supported by government or private funds.

Currently, there is very little evidence that storing your childs blood will help your own child fight a medical condition in the future. In fact, if your child needs stem cells to treat a condition, its more likely that they will receive a donation from a public cord bank.

When you donate to a public cord bank, you do not get to decide who will use your childs blood. You are essentially donating your childs cord blood to help a person in need.

Public cord banks are heavily regulated, and cord blood from these banks is used more frequently than cord blood from private banks. In fact, blood from public banks is used 30 times more frequently than from private banks.

Most major health organizations including the Academy of American Pediatrics and the American College of Obstetricians and Gynecologists recommend public cord blood banking.

Another reason these organizations recommend using public cord blood banks is that they are consistently and well regulated.

Cord blood banking at a public cord bank is free, and you will not have to pay any costs if you donate. These institutions are usually supported by federal funds or receive private funding.

On the other hand, private blood cord banks charge fees, and you must pay these fees for the entire time your childs cord blood is stored in these facilities.

Private cord banks generally charge an initial fee for collecting and processing cord blood. After these initial fees, you will also pay annual fees for ongoing storage. Private cord blood banks vary in their fee amounts, but they average about $2,000 for initial fees and between $100 and $175 each year for annual storage fees, per the AAP.

There are many benefits to banking cord blood. But how you do it depends on several factors, including your familys medical needs and your financial situation.

Almost anyone can choose to donate their infants cord blood to a public bank. Doing so may help many people. While most medical institutions do not recommend private cord banking, this may be the right choice for you if you have a family member who might use the cord blood you bank to treat a health condition.

Either way, its a good idea to speak with your healthcare professional before deciding on whether to bank your babys cord blood. They can also advise you on the best way to do it and which type of blood bank may best meet your needs.

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Cord Blood Banking: Benefits, Cost, and Process - Healthline

Orchard Therapeutics Announces Presentations at ASGCT 2022 Showcasing Potential of HSC Gene Therapy in Neurodegenerative Disorders and Beyond – Yahoo…

Orchard Therapeutics (Europe) Limited

BOSTON and LONDON, May 10, 2022 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today outlined seven presentations from across its platform to be featured at the American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting taking place May 16-19 in Washington, D.C. Featured presentations include updated results on the OTL-203 clinical program for mucopolysaccharidosis type I Hurler syndrome (MPS-IH), as well as several accepted abstracts highlighting preclinical work demonstrating the applicability of HSC gene therapy to potentially address other neurodegenerative and CNS-related conditions, including frontotemporal dementia (FTD).

The breadth of data to be presented at ASGCT represent notable progress in our efforts to realize the full potential of our HSC gene therapy platform, particularly for neurodegenerative and CNS-related disorders, said Leslie Meltzer, Ph.D., chief medical officer of Orchard Therapeutics. Our programs continue to demonstrate the unique ability of the HSC gene therapy approach to enable broad distribution of gene-corrected cells and localized delivery of therapeutic enzymes and proteins at clinically relevant concentrations not achievable by other modalities.

The full presentation details are as follows:

Monday, May 16

Presentation title: Up to 10.5 years of follow-up in 17 subjects treated with hematopoietic stem and progenitor cell lentiviral gene therapy for Wiskott-Aldrich syndrome Time: 2:15-2:30 p.m. EDT Lead Author: Dr. Francesca Ferrua Type: Oral Abstract Session Session Title: Gene and Cell Therapy Trials in Progress

Presentation title: Targeting CX3CR1 gene to improve microglia reconstitution and transgene delivery into the CNS upon hematopoietic stem and progenitor cell transplant Time: 4:00-4:15 p.m. EDT Lead Author: Dr. Annita Montepeloso Type: Oral Abstract Session Session Title: Hematopoietic Stem Cell Gene Therapy

Presentation title: Hematopoietic reconstitution and lineage commitment in HSC-GT patients are influenced by the disease background Time: 5:30-6:30 p.m. EDT Lead Author: Dr. Andrea Calabria Type: Poster Session Session Title: Hematologic and Immunologic Diseases I

Presentation title: Development of an ex vivo gene therapy for frontotemporal dementia (FTD) Time: 5:30-6:30 p.m. EDT Lead Author: Dr. Yuri Ciervo Type: Poster Session Session Title: Neurologic Diseases I

Story continues

Wednesday, May 18

Presentation title: Clinical trial results of hematopoietic stem cell gene therapy for mucopolysaccharidosis type I Hurler Time: 8:00-8:26 a.m. EDT Lead Author: Maria Ester Bernardo Type: Scientific Symposium Session Title: Inborn Metabolic Issues

Presentation title: Pathophysiological mechanisms of bone damage and bone cross correction in MPSIH gene therapy Time: 5:30-6:30 p.m. EDT Lead Author: Dr. Ludovica Santi Type: Poster Session Session Title: Musculo-skeletal Diseases

Presentation title: Innovative and regulated lentiviral promoter for the gene therapy of neurodegenerative diseases Time: 5:30-6:30 p.m. EDT Lead Author: Dr. Yuri Ciervo Type: Poster Session Session Title: Neurologic Diseases III

About Orchard Therapeutics At Orchard Therapeutics, our vision is to end the devastation caused by genetic and other severe diseases. We aim to do this by discovering, developing and commercializing new treatments that tap into the curative potential of hematopoietic stem cell (HSC) gene therapy. In this approach, a patients own blood stem cells are genetically modified outside of the body and then reinserted, with the goal of correcting the underlying cause of disease in a single treatment.

In 2018, the company acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Today, Orchard is advancing a pipeline spanning pre-clinical, clinical and commercial stage HSC gene therapies designed to address serious diseases where the burden is immense for patients, families and society and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit http://www.orchard-tx.com, and follow us on Twitter and LinkedIn.

Availability of Other Information About Orchard Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking Statements This press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as potential, continue to, and future or similar expressions that are intended to identify forward-looking statements. Except for statements of historical fact, information contained herein constitutes forward-looking statements and may include, but is not limited to, Orchards expectations regarding the safety and efficacy of its products and product candidates. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials of Orchards product candidates will not be repeated or continue in ongoing or future studies or trials involving its product candidates and the severity of the impact of the COVID-19 pandemic on Orchards business, including on preclinical and clinical development, its supply chain and its commercial programs. Given these uncertainties, the reader is advised not to place undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading Risk Factors in Orchards most recent annual or quarterly report filed with the U.S. Securities and Exchange Commission (SEC), as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

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Orchard Therapeutics Announces Presentations at ASGCT 2022 Showcasing Potential of HSC Gene Therapy in Neurodegenerative Disorders and Beyond - Yahoo...

Autologous Stem Cell and Non-Stem Cell Based Therapies Market to Witness Robust Expansion Throughout the Forecast Period 2022 2028 Queen Anne and…

Autologous Stem Cell and Non-Stem Cell Based Therapies Market Report incorporates a complete examination of the current market. The report begins with the fundamental Autologous Stem Cell and Non-Stem Cell Based Therapies industry review and afterward goes into every single detail.

Autologous Stem Cell and Non-Stem Cell Based Therapies Market Report contains inside and out data on significant producers, openings, difficulties, and industry patterns and their effect available gauge. Autologous Stem Cell and Non-Stem Cell Based Therapies Market additionally gives information about the organization and its activities. This report additionally gives data on the Pricing Strategy, Brand Strategy, Target Client, Distributors/Traders List offered by the organization.

Autologous Stem Cell and Non-Stem Cell Based Therapies Market Insight:

Autologous stem cell and non-stem cell based therapies market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 121.68 billion by 2027 growing at a CAGR of 3.75 % in the above-mentioned forecast period. The introduction of novelautologousstem cell based therapies inregenerativemedicine will help in driving the growth of the autologous stem cell and non-stem cell based therapies market.

Autologous Stem Cell and Non-Stem Cell Based Therapies Market competition by top manufacturers/players, with Autologous Stem Cell and Non-Stem Cell Based Therapies sales volume, Price (USD/Unit), Revenue (Million USD) and Market Share for each manufacturer/player; the top players including:Antria Inc., BrainStorm Cell Limited, Cytori Therapeutics Inc., Dendreon Pharmaceuticals LLC., Fibrocell Science, Inc., thinkBiotech LLC, Caladrius, Opexa Therapeutics, Inc., Orgenesis Inc, Regeneus Ltd,

Ask for a Free Sample Copy of the Report + All Related Graphs & Charts @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market&KA

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Brief Introduction to the research report. Table of Contents (Scope covered as a part of the study) Top players in the market Research framework (presentation) Research methodology adopted by Data Bridge Market Research

Scope of the Report:

Autologous Stem Cell and Non-Stem Cell Based Therapies MarketDynamics on the planet primarily, the overall Autologous Stem Cell and Non-Stem Cell Based Therapies Market is dissected across major worldwide locales. DBMR likewise gives tweaked explicit local and national level reports for the accompanying regions.

Region Segmentation:

North America(the USA, Canada and Mexico) Europe(Germany, France, UK, Russia and Italy) Asia-Pacific(China, Japan, Korea, India and Southeast Asia) South America(Brazil, Argentina, Columbia etc.) The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

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Table Of Contents: Autologous Stem Cell and Non-Stem Cell Based Therapies Market

Part 01:Executive Summary

Part 02:Scope of the Report

Part 03:Research Methodology

Part 04:Market Landscape

Part 05:Pipeline Analysis

Part 06:Market Sizing

Part 07:Five Forces Analysis

Part 08:Market Segmentation

Part 09:Customer Landscape

Part 10:Regional Landscape

Part 11:Decision Framework

Part 12:Drivers and Challenges

Part 13:Market Trends

Part 14:Vendor Landscape

Part 15:Vendor Analysis

Part 16:Appendix

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To summarize:

The global Autologous Stem Cell and Non-Stem Cell Based Therapies market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market to Witness Robust Expansion Throughout the Forecast Period 2022 2028 Queen Anne and...

New treatment for infants with weakened immune systems – Sciworthy

One of the most important systems in our bodies is the immune system. It defends our bodies from germs, infections, bacteria, viruses, and more. But, would you have imagined that about 1 in 58,000 babies are born with little to no Immune system? This is a very rare genetic disorder called Severe Combined Immunodeficiency (SCID). A baby can be diagnosed with SCID before birth through screenings, but most babies are diagnosed with SCID within the first six months of life.

When a child has SCID, it means they lack T cells, Natural Killer Cells, and Functional B cells. T Cells help protect the body from infection and help fight cancer. Natural Killer cells destroy cells infected with a virus. Functional B cells produce antibodies to fight bacteria and viruses.

The process of treating or curing a disease by altering a persons genes is known as gene therapy. In two previous studies conducted, SCID gene therapy consisted of two generations, both using viruses to deliver the genes.The first generation of treatment worked, but patients unfortunately developed leukemia, a cancer of the white blood cells that makes them abnormally large. The research community did deliver a second generation of gene therapies that were safer, but they did not completely restore the immune system.

To treat infants with SCID, stem cells are taken from the bone marrow of siblings, parents, or unrelated donors. Then, a bone marrow transplant introduces these healthy infection-fighting cells into the SCID infants body. The idea is that this will provide a new immune system for the patient. Generally, bone marrow stem cell transplants from family donors are effective but unavailable for more than 80% of patients in the world. This means a higher risk of the non-family donors T cells attacking and damaging the patients healthy cells.

In this study, the researchers used a type of gene therapy involving a lentiviral vector. A lentiviral vector is a type of virus called a lentivirus that inserts its RNA into the hosts cells. They took advantage of this viruss action to insert a corrected gene sequence, as an RNA strand, into the patients own bone marrow stem cells to both fix the genetic error and reduce the chance of rejection. The gene of interest is IL2RG, which instructs the body to make certain immune proteins in the bone marrow. When this gene is broken, SCID results.

The research team had successfully tried this type of treatment before in children and young adults with SCID. They combined the lentiviral vector gene therapy with a chemotherapy agent called nonmyeloablative busulfan, typically given to patients before a stem cell transplant. This drug destroys a patients bone marrow cells in preparation for new stem cells. The researchers hypothesized that lentiviral gene therapy, after a low dose of this drug busulfan, would be a safe and effective treatment for infants with recently diagnosed SCID.

First, the infants bone marrow was collected. The correct gene was inserted into the patients blood stem cells using the lentivirus vector or carrier. The cells were then frozen and went through quality testing in order to detect, reduce, and correct any problems that may have occurred. Importantly, the lentiviral vector contained protectors that prevented the gene therapy from accidentally causing leukemia. The protectors work by blocking the virus from turning on certain oncogenes (or cancer-linked genes) that happen to sit next to the IL2RG gene on the chromosome.

They recruited a group of eight infants newly diagnosed with SCID. The researchers conducted their experiment by giving the infants one to two daily doses of busulfan by injection. They customized the initial dose based on the weight and age of the patient and previous knowledge on how this drug typically moves through the body.

The results of the experiment supported the research teams prediction. Natural Killer cells were restored within the first four months in seven of the eights infants as the T cells. The eighth infant initially developed a low T cell count but improved after a boost of gene-corrected cells without needing additional busulfan pre-treatment. Several types of blood cells such as T, B and natural killer cells made in the bone marrow seemed active within 3-4 months after infusion with the viral lentiviral vector.

The combination of lentiviral gene therapy with busulfan conditioning appeared safe in all eight infants. These results aligned with what the researchers expected. Patients were followed for a range of 6-24 months after the study to assess whether their new immune system remained stable. After the 24 month period, they concluded that this treatment was more effective than current treatments for SCID patients with fewer side effects.

Original study: Lentiviral Gene Therapy Combined with Low-Dose Busulfan in Infants with SCID-X1

Study published on: 18 April 2019

Study author(s): E. Mamcarz, S. Zhou, T. Lockey, H. Abdelsamed, S.J. Cross, G. Kang, Z. Ma, J. Condori, J. Dowdy, B. Triplett, C. Li, G. Maron, J.C. Aldave Becerra, J.A. Church, E. Dokmeci, J.T. Love, A.C. da Matta Ain, H. van der Watt, X. Tang, W. Janssen, B.Y. Ryu, S.S. De Ravin, M.J. Weiss, B. Youngblood, J.R. LongBoyle, S. Gottschalk, M.M. Meagher, H.L. Malech, J.M. Puck, M.J. Cowan, and B.P. Sorrentino*

The study was done at: St. Jude Childrens Research Hospital, Memphis, TN, Hospital Nacional Edgardo Rebagliati Martins, Lima, Peru, Childrens Hospital Los Angeles, Los Angeles, University of California, San Francisco (UCSF) Benioff Childrens Hospital, University of New Mexico, University of Oklahoma Health Sciences Center, Departamento de Pediatria da Universidade de Taubat, Conselho Nacional de Medicina, So Paulo, Copperfield Childcare, Claremont, South Africa and National Institutes of Health, Bethesda

The study was funded by: This research was funded by the American Lebanese Syrian Associated Charities. The Researches received grants for the California Institute of Regenerative Medicine, The National Heart, Lung and Blood Institute, The National Cancer Institute, The Intramural program of the National Institute of Allergy and Infectious Diseases, and by the Assisi Foundation of Memphis

Raw data availability: Available in the article

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I Peace accelerates allogeneic iPSC-derived cell therapies with g high throughput method to identify a large number of donors with specific HLA…

PALO ALTO, Calif., May 11, 2022 /PRNewswire/ --I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up in the field of GMP cell manufacturing CDMO, announced that the company, in collaboration with Genequest Inc., a Tokyo-based direct-to-consumer genetic testing service provider, established a data-driven method to identify potential cell donors with specific haplotypes. With this high-throughput method, the company has already succeeded in identifying 1,547 HLA-homozygous potential donors and has already generated iPSCs. By combining Genequest's inventory of genomic information of tens of thousands of customers, and I Peace's mass production capability of GMP grade iPSCs (induced pluripotent stem cells) and iPSC-induced cells, it is now possible to identify potential donors with specific HLA (human leukocyte antigen) haplotype and manufacture multiple lines of iPSCs. Unlike conventional methods of identifying specific potential donors that yield only a handful of matches at best, this process can help identify a large number of potential donors with high efficiency.

We sequenced 98 HLA loci by high-resolution, next-generation sequencing-based HLA haplotyping from seven people, and found that the algorithm accuracy was above 93%. While the process can be applied to the identification of various genotypes and therefore has widespread usability including sourcing donors with genetic predispositions for disease modeling, HLA homozygosity was used to verify the reliability of the process because sourcing HLA homozygous donors is an ongoing challenge to meet demands of the rising allogeneic cell therapy industry. This process that combines the pool of genetic information and the mass manufacturing capability of iPSCs can be applied to identifying potential donors and manufacturing iPSCs with various types of genetic characteristics and support organ transplant and drug discoveries.

About I Peace, IncFounded in 2015 in Palo Alto, California, USA, I Peace, Inc. is a leading CDMO (contract development and manufacturing organization) of clinical-grade cell products. The founder and CEO Dr. Koji Tanabe earned his doctorate at Kyoto University under Nobel laureate Dr. Shinya Yamanaka and was the second author of the groundbreaking article on the development of human iPSCs. I Peace's mission is to ease the suffering of diseased patients and help healthy people maintain a high quality of life. With its proprietary manufacturing platform that enables parallel production of discrete iPSCs from multiple donors in a single room, I Peace can provide a large volume of high-quality clinical-grade iPSCs at a competitive cost. Our goal is to create custom iPSCs for every individual to become their stem cells for life while supporting drug and cell therapy companies to accelerate their development to make cell therapy an affordable option.

Founder, CEO: Koji Tanabe Since: 2015 Headquarters: Palo Alto, California Japan subsidiary: I Peace, Ltd. (Kyoto, Japan) Cell Manufacturing Facility: Kyoto, Japan Web: https://www.ipeace.com

About Genequest Inc.

In 2014, Genequest launched the first large-scale genetic testing service for consumers in Japan. We provide a service that allows you to check genetic variations associated with disease susceptibilities and traits by examining personal genomes covering about 300 items such as the risk of diseases such as lifestyle-related diseases and the characteristics of your trait. With the vision of promoting genetic research, spreading correct usage, and enriching people's lives, we are actively conducting research activities that utilize accumulated genomic data.

Web: https://genequest.jp/

SOURCE I Peace, Inc.

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I Peace accelerates allogeneic iPSC-derived cell therapies with g high throughput method to identify a large number of donors with specific HLA...

Stem Cell Therapy Market [PROFIT] Size, Share, Projections & Future Opportunities Recorded for the Period 2021-2030 – Taiwan News

Global Stem Cell Therapy Market Size study, By Cell Source (Adipose tissue-derived MSCs (mesenchymal stem cells), Bone marrow-derived MSCs, Placental/umbilical cord-derived MSCs, Other Cell Sources), By Type (Allogeneic Stem Cell Therapy, Autologous Stem Cell Therapy), By Therapeutic Application (Musculoskeletal Disorders, Wounds & Injuries, Cardiovascular Diseases, Surgeries, Inflammatory & Autoimmune Diseases, Neurological Disorders, Other), and Regional Forecasts 2022-2028

Global Stem Cell Therapy Market is valued approximately USD 160.52 million in 2021 and is anticipated to grow with a healthy growth rate of more than 16.5% over the forecast period 2022-2028.

Request To Download Sample of This Strategic Report: https://www.quadintel.com/request-sample/stem-cell-therapy-market/QI037

Stem cells are cells with the ability to grow into various different forms of cells in both animal and human bodies. These cells are majorly served as a repair system for the body and are often used in medicine and surgery. Stem cell therapy is also commonly called centerpiece therapy or regenerative medicine. Regenerative medications have the potential to revive cells and replace those that have been damaged or died. This cell therapy is used to treat a variety of chronic conditions, involves blood and cancer disorders. The growing prevalence of chronic disorders, availability of funding for stem cell research, increasing number of approvals for cell therapy production facilities, coupled with the rising clinical trials for stem cell based-therapies are the primary factors that may surge the market demand across the globe. For instance, in September 2020, Stemedica Cell Technologies get investigational new drug (IND) approval by the US FDA for the its intravenous allogeneic mesenchymal stem cells (MSCs) for curing moderate to severe COVID-19 patients.

Moreover, increasing initiatives by the public and private organizations to spread awareness and development in medical technology, along with rising government investments in healthcare facilities are further factors, which, in turn, surge the global market demand. However, the high cost of cell-based research and ethical concerns associated with the embryonic stem cells impede the growth of the market over the forecast period of 2022-2028. Also, growing demand for cell & gene therapies and the emergence of induced pluripotent stem cells (iPSCs) as an alternative to Embryonic stem cells (ESCs) are anticipated to act as a catalyzing factor for the market demand during the forecast period.

The key regions considered for the global Stem Cell Therapy Market study include Asia Pacific, North America, Europe, Latin America, and the Rest of the World. North America is the leading region across the world in terms of market share owing to the increasing number of clinical trials and growing public-private funding and research grants for evolving safe & effective stem cell therapy products. Whereas, Asia-Pacific is anticipated to exhibit the highest CAGR over the forecast period 2022-2028. Factors such as increasing government support, growing investment in the healthcare sector, as well an escalating patient pool, would create lucrative growth prospects for the Stem Cell Therapy Market across the Asia-Pacific region.

DOWNLOAD FREE SAMPLE REPORT https://www.quadintel.com/request-sample/stem-cell-therapy-market/QI037

Major market players included in this report are: MEDIPOST Anterogen Regrow Biosciences Stempeutics Research CORESTEM PHARMICELL NuVasive RTI Surgical AlloSource JCR Pharmaceuticals

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

By Cell SourceAdipose Tissue-Derived Mscs (Mesenchymal Stem Cells), Bone Marrow-Derived Mscs, Placental/Umbilical Cord-Derived Mscs, And Other Cell Sources

By TypeAllogeneic Stem Cell Therapy Autologous Stem Cell Therapy

By Therapeutic ApplicationMusculoskeletal Disorders Wounds & Injuries, Cardiovascular Diseases Surgeries, Inflammatory & Autoimmune Diseases Neurological Disorders, Other

Directly Purchase the Complete Global Stem Cell Therapy Market Research Report @ https://www.quadintel.com/request-sample/stem-cell-therapy-market/QI037

By Region:North America U.S. Canada Europe UK Germany France Spain Italy ROE

Asia Pacific China India Japan Australia South Korea RoAPAC Latin America Brazil Mexico Rest of the World

Furthermore, years considered for the study are as follows:

Historical year 2018, 2019, 2020 Base year 2021 Forecast period 2022 to 2028

Target Audience of the Global Stem Cell Therapy Market in Market Study:

Key Consulting Companies & Advisors Large, medium-sized, and small enterprises Venture capitalists Value-Added Resellers (VARs) Third-party knowledge providers Investment bankers Investors

Companies Mentioned

MEDIPOST Anterogen Regrow Biosciences Stempeutics Research CORESTEM PHARMICELL NuVasive RTI Surgical AlloSource JCR Pharmaceuticals

Access full Report Description, TOC, Table of Figure, Chart, etc. @ https://www.quadintel.com/request-sample/stem-cell-therapy-market/QI037

Table of Contents:

What aspects regarding the regional analysis Market are included in this report?

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We are the best market research reports provider in the industry. Quadintel believes in providing quality reports to clients to meet the top line and bottom line goals which will boost your market share in todays competitive environment. Quadintel is a one-stop solution for individuals, organizations, and industries that are looking for innovative market research reports.

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Stem Cell Therapy Market [PROFIT] Size, Share, Projections & Future Opportunities Recorded for the Period 2021-2030 - Taiwan News

SQZ Biotechnologies Announces First Data Presentation on Non-Clinical Studies of Point-of-Care Manufacturing System and Collaboration with STEMCELL…

WATERTOWN, Mass.--(BUSINESS WIRE)--SQZ Biotechnologies (NYSE: SQZ) announced today that the company will present data from the first non-clinical studies of its point-of-care (POC) manufacturing system at the 2022 American Society for Gene and Cell Therapy (ASGCT) Annual Meeting on May 18. The data will demonstrate an ability to produce SQZ cell therapy candidates with comparable or improved performance relative to conventional clean room manufacturing processes. In addition, SQZ announced a collaboration with STEMCELL Technologies to co-develop and commercialize a research-use-only (RUO) microfluidic intracellular delivery system. The new RUO system will be based on SQZs Cell Squeeze technology and will offer the life sciences community access to a unique cell engineering capability to advance preclinical research. These activities support SQZs mission to unlock the full potential of cell therapies for multiple therapeutic areas.

SQZs vision is to improve patient care by creating transformative cell therapies that can be broadly accessible around the world through rapid, cost-efficient manufacturing, said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. We are advancing these important goals through the development of our POC manufacturing system, which has the potential to substantially improve the accessibility and economic feasibility of cell therapies. Through our collaboration with STEMCELL, we intend to broaden technology access for research use and hope to facilitate advancement of the cell therapy field by the life sciences community.

This is an exciting collaboration that combines STEMCELLs life sciences research and product development capabilities with SQZs cell engineering expertise, said Allen Eaves, M.D., Ph.D., President and CEO of STEMCELL Technologies. The development of this RUO system, which will be well complemented by our various cell isolation and culture product portfolios, will provide the research community with a significant opportunity for their cell engineering investigations. By adapting the proven Cell Squeeze technology, with its ability to deliver multiple biological cargoes to a range of cell types, we anticipate the RUO system will offer enhanced flexibility to the scientific community. We look forward to our continued collaboration with SQZ and the development of this system.

SQZs Cell Squeeze technology has enabled the development of three oncology therapeutic candidates in active Phase 1/2 clinical trials. In addition to these programs, the company intends to file its first IND using the POC system for a SQZ TAC clinical candidate against celiac disease in the first half of 2023. The Cell Squeeze technology has also led to a number of preclinical developments in the areas of infectious disease and cell regeneration.

SQZs automated POC manufacturing system in development integrates, among other things, cell isolation, cell washing, intracellular delivery, and product filling. The system is designed to process patient material within a closed, single-use sterile disposable kit. The prototype system offers the potential to be operated outside of a clean roomwhich could ultimately allow decentralized cell therapy manufacturing by SQZ POC systems in a variety of care settings. SQZ will present data from the initial non-clinical studies of the POC system at ASGCT.

STEMCELL Technologies will present data from the first functional study findings for the RUO system at the ASGCT Annual Meeting. The data will demonstrate an ability to efficiently deliver cargoes to primary immune cell types. SQZ will also present new cell engineering data in hematopoietic stem cells using mRNA and CRISPR/Cas9 at the meeting.

ASGCT PRESENTATION TITLES AND TIMING

SQZ Point-of-Care Manufacturing Presentation Title: A Decentralized and Integrated Manufacturing System for the Rapid and Cost-Effective Production of Cell Therapy Drug Products SQZ Presenter: Maisam Dadgar Session Title: Cell Therapy Product Engineering, Development or Manufacturing Abstract Number: 1171 Date & Time: Wednesday, May 18, 2022, from 5:30-6:30 PM

STEMCELL TECHNOLOGIES Immune Cell Engineering Research Poster Presentation Title: A New Benchtop System for Simple and Versatile Introduction of Macromolecules into Human Lymphocytes by Microfluidic Squeezing STEMCELL Presenter: Eric Ouellet, Ph.D. Session Title: Synthetic/Molecular Conjugates and Physical Methods for Delivery II Abstract Number: 997 Date & Time: Wednesday, May 18, 2022, from 5:30-6:30 PM

SQZ Hematopoietic Stem Cell Research Title: Rapid, Gentle, and Scalable Engineering of Hematopoietic Stem Cells Using Vector-Free Microfluidic Cell Squeeze Technology SQZ Presenter: Murillo Silva, Ph.D. Session Title: Cell Therapy Product Engineering, Development or Manufacturing Abstract Number: 1176 Date & Time: Wednesday, May 18, 2022, from 5:30-6:30 PM

About SQZ Biotechnologies SQZ Biotechnologies Company is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies for patients around the world and has active programs in oncology, autoimmune and infectious diseases, as well as additional exploratory initiatives to support future pipeline growth. The companys proprietary Cell Squeeze technology offers the unique ability to deliver multiple biological materials into many cell types to engineer what we believe can be a broad range of potential therapeutics. With demonstrated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our approach could significantly broaden the therapeutic range and accessibility of cell therapies. The companys first therapeutic applications seek to generate target-specific immune responses, both in activation for the treatment of solid tumors and infectious diseases, and in immune tolerance for the treatment of autoimmune diseases. For more information, please visit http://www.sqzbiotech.com.

About STEMCELL Technologies STEMCELL Technologies supports life sciences research with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, educational resources, and contract assay services that are used by scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research globally. To learn more and receive future announcements about the RUO system in development, visit http://www.stemcell.com/RUOsystem.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements relating to events and presentations, our platform development, our product candidates, preclinical and clinical activities, progress and outcomes, development plans, manufacturing systems, clinical safety and efficacy results, therapeutic potential, collaborations and market opportunities. These forward-looking statements are based on management's current expectations. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, risks and uncertainties related to our limited operating history; our significant losses incurred since inception and expectation to incur significant additional losses for the foreseeable future; the development of our initial product candidates, upon which our business is highly dependent; the impact of the COVID-19 pandemic on our operations and clinical activities; our need for additional funding and our cash runway; the lengthy, expensive, and uncertain process of clinical drug development, including uncertain outcomes of clinical trials and potential delays in regulatory approval; our ability to maintain our relationships with our third party vendors and strategic collaborators; and protection of our proprietary technology, intellectual property portfolio and the confidentiality of our trade secrets. These and other important factors discussed under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission could cause actual results to differ materially from those indicated by the forward-looking statements. Any forward-looking statements represent management's estimates as of this date and we undertake no duty to update these forward-looking statements, whether as a result of new information, the occurrence of current events, or otherwise, unless required by law.

Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this press release, we have not independently verified, and we make no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources.

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SQZ Biotechnologies Announces First Data Presentation on Non-Clinical Studies of Point-of-Care Manufacturing System and Collaboration with STEMCELL...