Stem Cell Transplantation: What it Is, Process & Procedure

Overview What is a stem cell transplant?

Healthcare providers use stem cell transplants to treat people who have life-threatening cancer or blood diseases caused by abnormal blood cells. A stem cell transplant helps your body replace those blood cells with healthy or normal blood cells. If you receive a stem cell transplant, your provider may use your own healthy stem cells or donor stem cells.

Your blood cells come from stem cells in your bone marrow. Your bone marrow constantly creates new stem cells that become blood cells. Stem cell transplants can involve stem cells taken from bone marrow or from blood. Providers sometimes refer to stem cell and bone marrow transplants as haematopoietic stem cell transplants (HSCT). This article focuses on stem cells taken from blood.

Healthcare providers use stem cells to replace unhealthy blood cells that cause conditions such as several types of leukemia, lymphoma and testicular cancer. They also use transplanted stem cells to treat several types of anemia. Some people who have multiple sclerosis may benefit by receiving healthy stem cells. Researchers are investigating ways to treat other autoimmune diseases with stem cell transplants.

Healthcare providers typically use stem cell transplants to treat life-threatening cancer or blood diseases. Unfortunately, not everyone who has those conditions can have the procedure. Here are factors providers take into consideration:

Recently data reported nearly 23,000 people had stem cell transplants in 2018.

To understand how stem cell transplants work, it may help to know more about stem cells and their role in your body:

Healthcare providers obtain stem cells from several sources:

If youre a candidate for a stem cell transplant, your healthcare provider will perform the following tests to confirm youre physically able to manage transplantation processes, including pre-treatment chemotherapy called conditioning and transplantation side effects:

Before your blood tests, your provider may place a central venous catheter (CVC) in one of the large veins in your upper chest. CVCs are tubes that serve as central lines that providers use to take blood and provide medication and fluids. CVCs eliminate repeated needle sticks to draw blood or insert intravenous tubes throughout the transplantation process.

Transplant conditioning is intensive chemotherapy and/or radiation therapy that kills cancer cells in your bone marrow. Conditioning also kills existing blood cells.

If youre receiving your own stem cells, your provider may give you medication to boost your stem cell production. Theyll do follow-up blood tests to check on stem cell production.

If youre receiving your own stem cells, your providers will take blood so they can remove healthy stem cells for transplant. . To do that, they connect veins in both of your arms to a cell separator machine. The machine pulls your blood from one arm, filters the blood and then returns it to through your other arm. This process doesnt hurt. Providers may need to take blood more than once to ensure they have enough stem cells to transplant. The actual transplantation involves receiving your stem cells via your CVC.

Just like someone receiving their own cells, youll receive healthy stem cells via your CVC.

Your new stem cells will need time to produce new blood cells. If you received donor stem cells, your transplanted stem cells will replace unhealthy stem cells and begin to build a new immune system. This process is engraftment.

Either way, you may need to stay in or close to the hospital for several months so your healthcare providers can support your recovery and monitor your progress. Heres what you can expect after your stem cell transplant:

Successful stem cell transplants may help people when previous treatments dont slow or eliminate certain cancers.

The greatest risk is that youll go through the procedure and your transplanted stem cells cant slow or eliminate your illness.

Allogenic and autologous stem cell transplants have different complications. Allogenic stem cell transplants can result in graft versus host disease. This happens when your immune system attacks new stem cells. Potential complications will vary based on your overall health, age and previous treatment. If youre considering a stem cell transplant, your healthcare provider will outline potential complications so you can weigh those risks against potential benefits.

It can take several weeks to several months to recover from a stem cell transplant. Your healthcare provider may recommend you stay in or near the hospital or transplant center for the first 100 days after your procedure.

Its difficult to calculate an overall success rate. That said, the most recent data show the highest number of stem cell transplants involved people with multiple myeloma or Hodgkin and non-Hodgkin lymphoma who received autologous stem cell transplants. Here is information on three-year survival rates:

A successful stem cell transplant can change your life, curing your condition or slowing its growth. But its not an overnight transformation. It can take a year or more for you to recover. Here are some challenges and ways to overcome them:

You may have days when you feel exhausted and days when you feel fine. A hard day doesnt mean youre not doing well. It means you need to give yourself a break and take it easy.

Youll have regular follow-up appointments with your provider. But its important to remember your immune system likely will be weak for a year or so after your transplantation. Contact your provider right away if you develop any of the following symptoms:

A note from Cleveland Clinic

If youve been coping with cancer or a blood disease, a stem cell transplant can be a new lease on life. It can mean hope for a cure or remission when other treatments havent worked. But stem cell transplants come with demanding physical challenges and significant risks. Not everyone who has cancer or blood conditions is a candidate for a stem cell transplant. Unfortunately, not everyone who is a candidate but needs donor stem cells finds a donor. If youre considering a stem cell transplant, talk to your healthcare provider about potential risks and benefits. Theyll evaluate your situation, your options and potential outcomes.

Last reviewed by a Cleveland Clinic medical professional on 03/14/2022.

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Stem Cell Transplantation: What it Is, Process & Procedure

Century Therapeutics Receives Study May Proceed Notification from FDA for CNTY-101, the First Allogeneic Cell Therapy Product Candidate Engineered to…

Century Therapeutics, Inc.

Investigational New Drug Application for CNTY-101, a CAR-iNK product candidate targeting CD19 for B-cell malignancies, cleared by FDA

First cell product candidate engineered with six precision gene edits including a CD19-CAR, Allo-Evasiontechnology, IL-15 cytokine support and a safety switch

Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell malignancies anticipated to begin in 2H22

PHILADELPHIA, Aug. 25, 2022 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, announced today that the company has been notified by the U.S. Food and Drug Administration (FDA) that the Companys ELiPSE-1 clinical study may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is the first allogeneic cell therapy product candidate engineered with four powerful and complementary functionalities, including a CD19 CAR for tumor targeting, IL-15 support for enhanced persistence, Allo-Evasiontechnology to prevent host rejection and enhance persistence and a safety switch to provide the option to eliminate the drug product if ever necessary. CNTY-101 is manufactured from a clonal iPSC master cell bank that yields homogeneous product, in which all infused cells have the intended modifications.

This IND clearance is a significant milestone for Century as we execute on our vision to merge two disruptive platforms, precision gene editing and the powerful potential of iPSCs, to potentially move the allogeneic cell therapy field forward, and continue on our path to becoming a leader in the space, said Lalo Flores, Chief Executive Officer, Century Therapeutics. We believe that CNTY-101, our first and wholly owned product candidate, will be the most technically advanced and differentiated CD19-targeted cell product when it enters the clinic, which is anticipated to occur later this year. We look forward to assessing the potential of Allo-Evasionto prevent immunological rejection and enhance persistence of multiple dosing of CNTY-101 regimens with the aim to increase the proportion of patients that achieve durable responses.

Story continues

CNTY-101 is the first allogeneic cell product candidate with six genetic modifications incorporated using sequential rounds of CRISPR-mediated homologous recombination and repair that has received IND clearance by the FDA, said Luis Borges, Chief Scientific Officer, Century Therapeutics. We believe CNTY-101 will demonstrate the power of Centurys iPSC technology and cell engineering technology platforms. This accomplishment is a testament to the expertise and dedication of our team as we continue to make progress developing our pipeline of iPSC-derived NK and T cell product candidates.

The Phase 1 trial, ELiPSE-1 (NCT05336409), is intended to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CNTY-101 in patients with relapsed or refractory CD19-positive B-cell malignancies. All patients will receive an initial standard dose of conditioning chemotherapy consisting of cyclophosphamide (300 mg/m2) and fludarabine (30mg/m2) for 3 days. Schedule A of the trial includes a single-dose escalation of CNTY-101 and subcutaneous IL-2. Schedule B will evaluate a three-dose schedule per cycle of CNTY-101. Patients who demonstrate a clinical benefit are eligible for additional cycles of treatment with or without additional lymphodepletion pending FDA consent. We anticipate initiation of the Phase 1 trial later this year.

About Allo-Evasion

Centurys proprietary Allo-Evasiontechnology is used to engineer cell therapy product candidates with the potential to evade identification by the host immune system so they can be dosed multiple times without rejection, enabling increased persistence of the cells during the treatment period and potentially leading to deeper and more durable responses. More specifically, Allo-Evasion1.0 technology incorporates three gene edits designed to avoid recognition by patient/host CD8+ T cells, CD4+ T cells and NK cells. Knockout of beta-2-microglobulin or 2m, designed to prevent CD8+ T cell recognition, knock-out of the Class II Major Histocompatibility Complex Transactivator, or CIITA, designed to prevent CD4+ T cell recognition, and knock-in of the HLA-E gene, designed to enable higher expression of the HLA-E protein to prevent killing of CNTY-101 cells by host NK cells. Allo-Evasiontechnology may allow the implementation of more flexible and effective repeat dosing protocols for off-the-shelf product candidates.

About CNTY-101

CNTY-101 is an investigational off-the-shelf cancer immunotherapy product candidate that utilizes iPSC-derived natural killer (NK) cells with a CD19-directed chimeric antigen receptor (CAR) and includes Centurys core Allo-Evasionedits designed to overcome the three major pathways of host versus graft rejection - CD8+ T cells, CD4+ T cells and NK cells. In addition, the product candidate is engineered to express IL-15 to provide homeostatic cytokine support, which has been shown pre-clinically to improve functionality and persistence. Further, to potentially improve safety, the iNK cells were engineered with an EGFR safety switch, and proof-of-concept studies have demonstrated that the cells can be quickly eliminated by the administration of cetuximab, an antibody against EGFR approved by the U.S. Food and Drug Administration (FDA) for certain cancers. Initiation of the Phase 1, ELiPSE-1 trial in relapsed or refractory CD19-positive B-cell malignancies in multiple centers in the United States is anticipated to begin in the second half of 2022.

About Century Therapeutics

Century Therapeutics, Inc. (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care. For more information on Century Therapeutics please visithttps://www.centurytx.com/.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our clinical development plans and timelines are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as may, might, will, should, expect, plan, aim, seek, anticipate, could, intend, target, project, contemplate, believe, estimate, predict, forecast, potential or continue or the negative of these terms or other similar expressions. The forward-looking statements in this presentation are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our ability to obtain FDA acceptance for our future IND submissions and commence clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of the COVID-19 pandemic, geopolitical issues and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our future clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the Risk Factors section of our most recent filings with the Securities and Exchange Commission and available at http://www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

For More Information:

Company: Elizabeth Krutoholow investor.relations@centurytx.com

Investors: Melissa Forst/Maghan Meyers century@argotpartners.com

Media: Joshua R. Mansbach century@argotpartners.com

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Century Therapeutics Receives Study May Proceed Notification from FDA for CNTY-101, the First Allogeneic Cell Therapy Product Candidate Engineered to...

Inside the race to make human sex cells in the lab – MIT Technology Review

But there are other hurdlessome so challenging that many scientists have given up. For one thing, nudging the stem cells in the right direction requires, it seems, a unique touch and expertise. Not just anyone will be able to make egg and sperm cells in the lab, says Saitou.

Saitou and Hayashi, now at Kyushu University, lead world-renowned teams of extraordinary skill. Their achievements might not have been possible without the contributions of Hiroshi Ohta, for example. Ohta is an expert in anesthetizing newborn mice using ice, performing intricate surgery on them, and injecting cells into the animals miniature gonads. The entire procedure must be completed within five minutes or the animals die. Only a few people have such skills, which take months to develop. I think our group was kind of lucky, says Saitou. It was a get-together of many talented scientists.

The work is hampered by the lack of in-depth knowledge about how the primitive forms of egg and sperm cells develop naturally in the embryoa process that is far from fully worked out in humans. Some of the embryos cells begin to differentiate into these primitive sex cells at around 14 days. But in some countries, it is illegal for researchers to even grow human embryos beyond 14 days. They would send me to jail if I went beyond day 14, says Azim Surani, who is working with precursors to artificial sex cells at the University of Cambridge in the UK.

The problem, from a research point of view, is that the 14-day rule comes in just as the embryos start to get interesting, says Surani. Without being able to easily study the critical process of how primitive cells begin forming egg and sperm cells, scientists are limited in their ability to mimic it in the lab.

Even if scientists were able to study embryos more freely, some mysteries would remain. Once the cells that make eggs and sperm are created, they are held in a kind of suspended animation until puberty or ovulation. What happens to them in the years in between? And how important is this phase for the health of mature eggs and sperm? The honest answer is we dont know, says Surani.

The stem cells in the lab must also be generated and cared for under precise conditions. To survive, they must be bathed in a cocktail of nutrients that must be replaced every day. Its very time consuming and labor intensive and it takes a lot of money, says Bjorn Heindryckx at Ghent University in Belgium, one of the scientists who have given up on creating human eggs this way in the lab. The outcome was too limited for the effort and the money that we spent on it, he says.

Part of the challenge is that for the precursor stem cells to develop into fully matured egg or sperm cells, they must be placed in an environment mimicking that of newly developing ovaries or testes. Researchers studying mice use tissue taken from mouse embryos to induce the stem cells to differentiate into sex cells. But similarly using human tissue from discarded embryos is ethically and legally problematic. So scientists are working on ways to create the right environment without using tissue from embryos.

The upshot is that it will likely take a highly skilled team years of dedicated research. Its not impossible, but it would not be easy to do, says Surani.

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Inside the race to make human sex cells in the lab - MIT Technology Review

This company is about to grow new organs in a person for the first time – MIT Technology Review

And the lymph nodes near the liver are close enough to receive chemical distress signals sent out by the dying tissue of a diseased liver, says Lagasse. These signals are meant to encourage any remaining healthy liver tissue to regenerate, but this doesnt work in cases of severe disease. However, the signals do appear to help along the growth of liver tissue in neighboring lymph nodes.

Its incredible, says Gouon-Evans. Having this little incubator in the body [that can grow organs] is just amazing.

LYGENESIS

Around five years ago, Lagasse, along with entrepreneur and drug developer Michael Hufford and transplant surgeon Paulo Fontes, founded LyGenesis to take the technology further. The team are exploring the use of lymph nodes to grow new thymuses, kidneys, and pancreases.

But the companys priority is livers. Over the last 10 years, members of the team have collected promising evidence that suggests they can use their approach to grow new mini livers in mice, pigs, and dogs. The mini livers dont grow indefinitelythe body has an internal regulator that stops liver growth at a certain point, which is why healthy livers dont overshoot when they regenerate.

The teams research in mice with a genetic liver disorder has shown that most of the cells injected into a lymph node will stay there but some will migrate to the liver, providing there is enough healthy liver tissue remaining. These migrating cells can help the remaining liver tissue regenerate and heal. When this happens, the new mini liver in the lymph node will shrink, keeping the total amount of liver tissue in balance, says Lagasse.

Other studies have focused on pigs and dogs that have the blood supply to the liver diverted, causing the organ to die. Injecting liver cells into the animals lymph nodes will eventually rescue their liver function.

In the pig study, for example, the team first surgically diverted the blood supply away from the liver in six animals. Once the pigs had recovered from surgery, the team injected healthy liver cells into their lymph nodes. The doses ranged from 360 million cells injected across three lymph nodes to 1.8 billion cells across 18 lymph nodes.

Within a couple of months, all the animals appeared to show recovery from their liver damage. Tests suggested their liver function had improved. And when the team later performed autopsies on the animals, the new organs in the lymph nodes looked very much like miniature healthy livers, each up to around 2% of the size of a typical adult liver. Other studies suggest it takes around three months for the treatment to have significant benefits.

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This company is about to grow new organs in a person for the first time - MIT Technology Review

Global Cell Banking Outsourcing Market to Grow at a CAGR of ~18% during 2022-2031; Market to Expand Owing to the Development of Advanced Cell…

New York, Aug. 23, 2022 (GLOBE NEWSWIRE) -- Kenneth Research has published a detailed market report on Global Cell Banking Outsourcing Market for the forecast period, i.e., 2022 2031, which includes the following factors:

Global Cell Banking Outsourcing Market Size:

The global cell banking outsourcing market generated the revenue of approximately USD 7200.1 million in the year 2021 and is expected to garner a significant revenue by the end of 2031, growing at a CAGR of ~18% over the forecast period, i.e., 2022 2031. The growth of the market can primarily be attributed to the development of advanced preservation techniques for cells, and increasing adoption of regenerative cell therapies for the treatment of chronic diseases such as cancer. Additionally, factors such as growing demand for gene therapy, and increasing worldwide prevalence of cancer are expected to drive the market growth. According to the World Health Organization, nearly 10 million people died of cancer across the globe in 2020. The most recurrent cases of deaths because of cancer were lung cancer which caused 1.80 million deaths, colon, and rectum cancer which caused 916 000 deaths, liver cancer which caused 830 000 deaths, stomach cancer which caused 769 000 deaths, and breast cancer which caused 685 000 deaths. Furthermore, it was noticed that about 30% of cancer cases in low and lower-middle income nations are caused by cancer-causing diseases such the human papillomavirus (HPV) and hepatitis.

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Global Cell Banking Outsourcing Market: Key Takeaways

Increasing Geriatric Population across the Globe to Boost Market Growth

Increasing demand for stem cell therapy, and increasing biopharmaceutical production are estimated to fuel the growth of the global cell banking outsourcing market. Among the geriatric population around the world, the demand of stem cell therapy is at quite a high rate. Hence, growing geriatric population across the globe is also expected be an important factor to influence the market growth. According to the data by World Health Organisation (WHO), the number and proportion of geriatric population, meaning the people aged 60 years and older in the population is rising. The number of people aged 60 years and older was 1 billion in 2019. This number is estimated to increase to 1.4 billion by 2030 and 2.1 billion by 2050.

In addition to this, increasing prevalence of chronic diseases, supportive initiatives by governments around the world, and growing awareness about stem cell banking are predicted to be major factors to propel the growth of the market. The growth of the global cell banking outsourcing market, over the forecast period, can be further ascribed to the rising investments in the R&D activities to continuously bring up more feasible solutions for medical procedures. According to research reports, since 2000, global research and development expenditure has more than tripled in real terms, rising from approximately USD 680 billion to over USD 2.5 trillion in 2019.

Browse to access In-depth research report on Global Cell Banking Outsourcing Market with detailed charts and figures: https://www.kennethresearch.com/report-details/cell-banking-outsourcing-market/10070777

Global Cell Banking Outsourcing Market: Regional Overview

The global cell banking outsourcing market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa region.

Advanced Healthcare Facilities Drove Market in the North America Region

The market in the North America region held the largest market share in terms of revenue in the year 2021. The growth of the market in this region is majorly associated with the increasing number of pharmaceutical companies & manufacturers in the region, and increasing awareness for the use of stem cells as therapeutics. Increasing number of bone marrow and cord blood transplants throughout the region is also estimated to positively influence the market growth. It was noted that, 4,864 unrelated and 4,160 related bone marrow and cord blood transplants were performed in the United States in 2020.

Increasing Prevalence of Chronic Diseases to Influence Market Growth in the Asia Pacific Region

On the other hand, market in the Asia Pacific region is estimated to grow with the highest CAGR during the forecast period. The market in this region is driven by the increasing investment in biotechnology sector by government and private companies specifically in countries such as China, India, and Japan. Moreover, the increasing pool of patient with chronic diseases, such as cancer, and the ongoing research & development activities for cancer treatment is expected to propel the growth of the market. Further, increasing percentage of regional health expenditure contributing to the GDP is also estimated to be a significant factor to influence the growth of the cell banking outsourcing market in the Asia Pacific region. As per The World Bank, in the year 2019, share of global health expenditure in East Asia & Pacific region accounted to 6.67% of GDP.

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The study further incorporates Y-O-Y growth, demand & supply and forecast future opportunity in:

Middle East and Africa (Israel, GCC [Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman], North Africa, South Africa, Rest of Middle East and Africa).

Global Cell Banking Outsourcing Market, Segmentation by Bank Phase

The bank storage segment held the largest market share in the year 2021 and is expected to maintain its share by growing with a notable CAGR during the forecast period. The market growth is anticipated to be driven by the development of effective preservation technologies such as cryopreservation technique. Cryopreservation is a technique in which low temperature is used to preserve the living cells and tissue for a longer time. With the growing healthcare expenditure per capita across the world, demand for bank storage increasing notably. As sourced from The World Bank, in 2019, worldwide health expenditure per capita was USD 1121.97.

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Global Cell Banking Outsourcing Market, Segmentation by Product

The adult cell banking segment is estimated to hold a substantial market share in the global cell banking outsourcing market during the forecast period. The growth of this segment can be attributed to the significant prevalence of chronic diseases among the adults around the globe. For instance, according to the National Library of Medicine 71.8% of adult population suffered from cardiovascular diseases, 56% had diabetes, and 14.7% adults had arthritis as of 2020.

Global Cell Banking Outsourcing Market, Segmentation by Cell Type

Global Cell Banking Outsourcing Market, Segmentation by Bank Type

Few of the well-known market leaders in the global cell banking outsourcing market that are profiled by Kenneth Research are SGS SA, WuXi AppTec, LifeCell International Pvt. Ltd., BSL Bioservice, LUMITOS AG, Cryo-Cell International, Inc., REPROCELL Inc, CORDLIFE GROUP LIMITED, Reliance Life Sciences, and Clean Biologics and others. Enquiry before Buying This Report @ https://www.kennethresearch.com/sample-request-10070777

Recent Developments in the Global Cell Banking Outsourcing Market

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Global Cell Banking Outsourcing Market to Grow at a CAGR of ~18% during 2022-2031; Market to Expand Owing to the Development of Advanced Cell...

Myeloid Therapeutics Strengthens Senior Team to Support the Expansion of its Manufacturing Capabilities – PR Newswire

CAMBRIDGE, Mass., Aug. 23, 2022 /PRNewswire/ -- Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company harnessing the power of myeloid and innate biology to engineer novel therapies that elicit a broad immune response for cancer and autoimmune diseases, today announced that it has expanded its manufacturing capabilities with the appointments of Jerome Chal, Ph.D., as Vice President, Process Development, and Eric Chapdelaine as Vice President, CMC Operations.

"We are thrilled to continue to attract the highest levels of talent to Myeloid, as we expand our manufacturing capabilities to support our clinical-stage cell therapy programs and the advancement of our in vivo cell programming programs into the clinic next year," said Daniel Getts, Ph.D., CEO of Myeloid. "Jerome and Eric bring a diverse set of skills with significant quality and CMC experience at leading companies like Vertex, Alnylam, and Genzyme. As senior leaders, they will provide invaluable stewardship as we advance and expand our pipeline and read out more clinical data. We are thrilled to welcome them to the Myeloid team, and we look forward to their contributions to our technology and the cell therapy field generally."

Jerome Chal, Ph.D., Vice President, Process Development

Dr. Chal brings to Myeloid over twenty years of experience in the biotechnology industry, with a focus on CMC leadership across multiple therapeutic modalities, including cell and gene therapies, with landmark achievements in the field. Prior to Myeloid, Jerome was Executive Director, Analytical Sciences at Vertex Pharmaceuticals, where he provided strategic leadership to a multi-site and multi-department CMC organization across the T1D, blood disorders and DMD programs, along with end-to-end implementation of all analytical CMC activities from preclinical to pivotal stage. Prior to Vertex, Dr. Chal was Associate Director, Cell and Analytical Development at Semma Therapeutics, where he directed cell, process and assay development programs for cell therapy products based on a proprietary preclinical-stage PSC-based pancreatic islets (SC-islets) platform. Earlier in his career, he held positions of increasing responsibility at Coyne Scientific, IGBMC in Strasbourg, France, and faculty scientist at Brigham and Women's Hospital, Harvard Medical School. Dr. Chal received his MS in Biology-Biochemistey from ENS Paris, Paris 7 University, an MS in Molecular and Cellular Developmental Biology from Sorbonne University, and a Ph.D. in Stem Cell and Developmental Biology from Sorbonne University/Stowers Institute, Kansas City, MO. Dr. Chal is a decorated scientist with multiple patents and over twenty peer-reviewed publications in the fields of cell and gene therapy.

Eric Chapdelaine , Vice President, CMC Operations

Mr. Chapdelaine has over twenty years of experience leading Manufacturing, CMC, Quality (QC+QA), Analytical Development, and Regulatory Affairs organizations in cell and gene therapy. Eric has overseen and led IND and NDA filings for multiple products that received approval in the US and EU. Prior to joining Myeloid, Eric was Senior Vice President of Operations at iVexSol, Inc., where he designed and optimized the manufacturing facility layout, flow and associated office space, as well as overseeing the buildout of the cGMP manufacturing facility. Earlier, he was Vice President of Manufacturing at Genprex, Inc., where he was responsible for translating the corporate strategy into supportive strategies for global pharmaceutical manufacturing, packaging, supply chain, logistics and quality control from early product development through global manufacturing for commercial products. He has also held senior positions at Cognate Bioservices, Inc., and Alnylam Pharmaceuticals, where he was responsible for authoring CMC sections for regulatory submissions, IMPD/IND/NDA, for Patisiran and Givosiran, which are the first two RNA interference therapeutics approved for commercialization in the US and EU. Eric started his career in positions within quality control, manufacturing and CMC at Genzyme Corporation, VaxInnate Corporation, and Pfizer, Inc, respectively. Mr. Chapdelaine holds a Bachelor's of Science from the University of Massachusetts at Amherst and a Masters of Science, Chemistry, from Vanderbilt University.

About Myeloid Therapeutics

Myeloid Therapeutics is a clinical stage mRNA-immunotherapy company harnessing the power of myeloid cell biology to engineer new therapeutic alternatives for patients with cancer and autoimmune diseases.Integrating the fields of RNA biology, immunology, and medicine, the Company's proprietary platform provides clinical solutions that match therapeutic modalities to disease conditions, including use of autologous cell therapies, in vivo cell programming using mRNA, RNA-based gene-editing using RetroT and multi-targeted biologics. Myeloid is advancing a broad portfolio of clinical and preclinical candidates designed to enable full immune system responses. Myeloid has entered into strategic partnerships with Prime Medicine and Acuitas and is supported by well-known biotechnology investors. Myeloid is headquartered in Boston, MA. For more information, visit https://www.myeloidtx.com/.

Investor and Media ContactAmy Conrad Juniper Point [emailprotected] 858-914-1962

SOURCE Myeloid Therapeutics

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Myeloid Therapeutics Strengthens Senior Team to Support the Expansion of its Manufacturing Capabilities - PR Newswire

Personalized Regenerative Medicine Celebrates the Grand Reopening of their San Clemente Location – Benzinga

Personalized Regenerative Medicine, the San Clemente office of Dr. Steenblock, announces its grand reopening celebration. This event will be held at 187 Av. La Pata, San Clemente, CA 92673 on Thursday, September 1st from 5:30 to 7:30 PM. The celebration produced by Rachel Dares PR includes a red carpet, a ribbon-cutting ceremony, a DJ, delectable food, refreshments, press coverage, VIP swag bags, and raffle prizes. Come enjoy this wonderful occasion with the staff of Dr. Steenblock, his patients, generous sponsors, the local community, San Clemente Chamber of Commerce members, and local officials.

Dr. David Steenblock is widely regarded as one of the country's foremost stem cell experts, specializing in the treatment of ALS, TBI, Cerebral Palsy, Osteoarthritis, and stroke. Dr. David Steenblock, D.O., is an interdisciplinary medical genius who is exploring uncharted territory to find the best treatment for his patients.

The San Clemente Chamber of Commerce will host a Ribbon Cutting Ceremony as part of the festivities. Author, humanitarian, superfood creator, TV show, and radio personality Dr. Tony O'Donnell will serve as the event's emcee. Delicious food and beverages will be provided by local businesses, including mouthwatering appetizers sponsored by BASANTI Indian Cuisine, signature cheese boards by Riviera, delicious chips & salsa from Chelas Mexican Restaurant, scrumptious fresh baked goods from Elisa Marie Baking, thirst-quenching bottled water from MOTUS Physical Therapy, appetizing deli platters from Primerica, and delightful salad trays from The Kitchen Lady. The party will also feature music by DJ George.

The first 25 early attendees will receive VIP Swag Bags from Orange Sculpting inclusive of Dr.Steenblocks break-through supplement, Stemgevity which utilizes encapsulated stem cell growth activators to help patients relieve pain, promote tissue regeneration, stimulate collagen, and see fast results in overall youth factors.

With the generous sponsorship fromHome Saver Realty, the event will also feature great photo opportunities with a red carpet and backdrop banner. Amazing raffle prizes will be given out to lucky winners throughout the evening provided by Laguna Aesthetics, The Kitchen Lady, Orange Sculpting, Radiant Greens, The Dorothea Clinic and Rachel Dares PR!

The office of Personalized Regenerative Medicine invites everyone to witness and experience the future of regenerative medicine and to see for yourselves what all the excitement is about! RSVP now on Event Brite!

Media Contact Company Name: Rachel Dares PR Contact Person: RACHEL B DARES Email: Send Email Phone: 7147189043 Address:16480 Bake Parkway #106 City: Irvine State: CA Country: United States Website: http://www.RachelDaresPR.com

Press Release Distributed by ABNewswire.com To view the original version on ABNewswire visit: Personalized Regenerative Medicine Celebrates the Grand Reopening of their San Clemente Location

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Personalized Regenerative Medicine Celebrates the Grand Reopening of their San Clemente Location - Benzinga