Stem Cell Clinic

Nerve Repair and Regeneration Market Size Worth $12,514 – GlobeNewswire

By Stem Cell Clinics

New York, Sept. 02, 2022 (GLOBE NEWSWIRE) -- The Insight Partners published latest research study on Nerve Repair & Regeneration Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Product {Neurostimulation & Neuromodulation Devices [Internal Neurostimulation Devices (Spinal Cord Stimulation, Deep Brain Stimulation, Vagus Nerve Stimulation, Sacral Nerve Stimulation, and Gastric Electrical Stimulation) and External Neurostimulation Devices (Transcutaneous Electrical Nerve Stimulation Devices, Transcranial Magnetic Stimulation Devices, Respiratory Electrical Stimulation Devices)] and Biomaterials [Nerve conduits, Nerve wraps, Nerve Connectors, and Other Biomaterials]} and Application {Neurostimulation & Neuromodulation Applications [Internal neurostimulation & neuromodulation and External neurostimulation & neuromodulation], and Nerve Repair & Regeneration Applications [Direct Nerve Repair/Neurorrhaphy (Epineural Repair, Perineural Repair, and Group Fascicular Repair), Nerve Grafting (Autografts, Allografts, and Xenografts), and Stem cell therapy]}, the global nerve repair & regeneration market size is projected to reach USD 12,514.06 million by 2028 from USD 6,607.71 million in 2021; it is expected to grow at a CAGR of 9.7% from 2022 to 2028.

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Nerve Repair and Regeneration Market Report Scope & Strategic Insights:

Global Nerve Repair & Regeneration Market: Competitive Landscape and Key Developments A few companies in the global nerve repair & regeneration market are Axogen Corporation, Boston Scientific Corporation, Integra LifeSciences, Medtronic, Abbott Laboratories, Stryker Corporation, Neuronetics, LivaNova PLC, Baxter, and Polyganics BV. The companies operating in the global nerve repair & regeneration market implement various growth strategies, such as product launches, expansions, and product upgrades. Similarly, several companies are implementing inorganic strategies such as acquisitions, collaboration, and partnerships.

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In Aug 2021, Checkpoint Surgical, Inc. launched the NeuroShield Chitosan Nerve Wrap to expand its intraoperative nerve care product line. The NeuroShield Wrap marks the company's first product in a planned line of chitosan-based biological implants to support nerve healing. Adding the product complements the existing product portfolio of Checkpoint Surgical, including the companys flagship Checkpoint Nerve Stimulator/Locator, the leading nerve stimulation device for intraoperative nerve protection and repair.

In Mar 2021, Abbott launched NeuroSphere Virtual Clinic in the US, a first-of-its-kind technology enabling patients to interact with physicians, ensure proper functionality and settings, and receive new treatment settings remotely as per requirement. The NeuroSphere Virtual Clinic can extend access to optimal treatment for patients with movement disorders or chronic pain who don't live near a care provider, who can not access care easily or are unable to visit a physician due to circumstances such as COVID-19.

The nerve repair and regeneration market growth is attributed to the growing incidence of nerve injuries and the high prevalence of neurological disorders, the growing geriatric population and rising prevalence of age-associated neurological disorders, and increasing funding by private and government organizations for research in neurology. However, the absence of trained professionals is hampering the growth of the global nerve repair & regeneration market.

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Global Nerve Repair & Regeneration Market: Key Insights Future Trend Nerve repair and regeneration offers products such as neuromodulators & neurostimulation devices, and biomaterials. These devices treat neurodegenerative or traumatic disorders such as Parkinson's disease, Alzheimer's disease, sclerosis, multiple system atrophy, and amyotrophic lateral sclerosis. Therefore, market players are launching various products such as internal neurostimulation devices, external neurostimulation devices, nerve conduits, nerve wraps, nerve connectors, and other biomaterials to enhance the treatment output of nerve repair and regeneration.

A few of the recent developments related to the nerve repair and regeneration market are mentioned below:

In July 2022, Checkpoint Surgical launched the Checkpoint Edge Nerve Cutting Kit, expanding the strength of the intraoperative nerve care portfolio of the company. The Checkpoint Edge Nerve Cutting Kit is the first offering in the planned portfolio of nerve-specific instruments by Checkpoint Surgical, with further expansion planned in the future.

In April 2022, Boston Scientific Corporation received US Food and Drug Administration (FDA) approval for its latest image-guided programming software, Vercise Neural Navigator with STIMVIEW XT. The product is developed in collaboration with Brainlab AG. STIMVIEW XT allows physicians, in real-time, the capacity to visualize both stimulation modeling and lead placement of the brain anatomy of their patients having an essential tremor or Parkinsons disease.

In Mar 2022, Integra LifeSciences Holding Corporation launched the NeuraGen 3D Nerve Guide Matrix, which is a resorbable implant to repair peripheral nerve discontinuities. NeuraGen 3D is a nerve repair product specifically engineered to develop an optimized environment that enables a greater complete functional recovery following mid-gap nerve repair in comparison to hollow nerve conduits alone.

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In Jan 2022, Medtronic plc received US Food and Drug Administration approval for its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator treating chronic pain associated with diabetic peripheral neuropathy (DPN).

Thus, the active participation of market players in product innovation and development and increase in approvals of products are likely to fuel the market growth in the coming years.

Global Nerve Repair & Regeneration Market: Product Overview Based on product, the nerve repair & regeneration market is bifurcated into neurostimulation & neuromodulation devices and biomaterials. Neurostimulation & neuromodulation devices segment is further bifurcated into internal neurostimulation devices and external neurostimulation devices. Internal neurostimulation devices segment is further subsegmented into spinal cord stimulation, deep brain stimulation, vagus nerve stimulation, sacral nerve stimulation, and gastric electrical stimulation. External neurostimulation devices is further subsegmented into transcutaneous electrical nerve stimulation devices, transcranial magnetic stimulation devices, respiratory electrical stimulation devices. The neurostimulation and neuromodulation devices segment held the largest share of the market in 2021 and is anticipated to register the highest CAGR in the market during the forecast period. The growing prevalence of neurological disorders, increasing application of neurostimulation and neuromodulation devices, and rapid advancements are driving the market growth of the nerve repair & regeneration market.

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Browse Adjoining Reports: Nerve Repair Biomaterial Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Product (Nerve Protection, Nerve Repair); Application (Epineural Nerve Repair, Perineural Nerve Repair, Group Fascicular Repair); End User (Hospitals and Clinics, Ambulatory Surgery Centers, Other) and Geography

Nerve Repair and Re-generation Biomaterials Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type (Nerve Conduits, Nerve Wraps, Nerve Graft, Others); Application (Neurorrhaphy, Nerve Grafting, Stem Cell Therapy, Others) and Geography

Neurostimulation Devices Market Forecast to 2028 - Covid-19 Impact and Global Analysis - By Product (Deep Brain Stimulation Device, Spinal Cord Stimulation Device, Sacral Nerve Stimulation Device, Vagus Nerve Stimulation Device, and Gastric Electric Stimulation Device), Application (Pain Management, Epilepsy, Depression, Parkinson's Disease, Essential Tremor, Urinary and Fecal Incontinence, and Other Applications), and Geography

Neuromodulation Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Technology (External (Non-Invasive) Neuromodulation, and Internal Neuromodulation); Application (Chronic Pain Management, Failed Back Syndrome, Epilepsy, Tremor, Incontinence, Depression, Dystonia, Gastroparesis, Parkinson

Neuromodulation Devices Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type (Internal, External); Application (SCS, DBS, VNS, SNS, GES, TENS, TMS); Biomaterial (Metallic, Polymeric, Ceramic); End-User (Hospitals, Clinics, Homecare) and Geography

Biomaterials Market Forecast to 2028 - Covid-19 Impact and Global Analysis - by Type (Metallic, Ceramic, Polymers, Natural); Application (Cardiovascular, Orthopedic, Dental, Plastic Surgery, Wound Healing, Neurological disorders, Tissue Engineering, Ophthalmology)

Biomaterials Devices Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type ( Natural Biomaterials, Polymers Biomaterials, Ceramic Biomaterials, Metallic Biomaterials ); Application ( Orthopedic, Cardiovascular, Dental, Ophthalmology, Tissue Engineering, Other ) and Geography

Deep Brain Stimulation Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Product (Single Channel Deep Brain Stimulator, Dual Channel Deep Brain Stimulator.); Application (Parkinson's Disease, Tremor, Depression, Alzheimer's Disease, Dystonia and Tourette Syndrome); End User (Hospitals, Research Centres) and Geography

Transcranial Magnetic Stimulator (TMS) Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type (Single or Paired Pulse TMS, Repetitive TMS (rTMS)); Age Group (Adults, Children); Application (Research, Diagnostic, Therapeutic), and Geography

Implantable Neurostimulation Devices Market Forecast to 2028 - COVID-19 Impact and Global Analysis by Technology ( spinal cord stimulation (SCS), deep brain stimulation (DBS), sacral nerve stimulation (SNS), gastric electric stimulation (GES), vagus nerve stimulation (VNS), others ); Application ( pain management, epilepsy, Parkinson's, urinary and fecal incontinence, others )

Low-Frequency Sine Wave Neurostimulation Therapy Devices Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Product (Percutaneous treatment, Implantation); Application (Urinary impulse, Interstitial cystitis, Idiopathic constipation) and Geography

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Nerve Repair and Regeneration Market Size Worth $12,514 - GlobeNewswire

Regenerative Medicine: An alternative to surgery and pills | Loop Cayman Islands – Loop News Cayman

By Stem Cell Medicine

Surgical methods of repair have long since been touted as the best approach to treatment and healing for patients with long-term, degenerative conditions.

While effective, factors such as high costs, long downtime, surgical complications and more can be a deterrent for patients who are considering surgery for non-life-threatening conditions.

Regenerative Medicine is an approach available for some patients who are seeking pain relief and long-term healing and would like to reduce the need for surgery.

Regenerative medicine can be defined as the process of replacing or regenerating human cells or tissues to facilitate healing and repair. The ability to encourage this repair in the human body reduces the time most patients will remain ill and offers many possibilities in the field of medicine.

In understanding the regenerative process, it is important to note that the potential for repair and the ability to repair are two separate things. We all have the potential to repair but we dont all have the ability. Increasing the ability to repair is considered one of the main benefits of regenerative medicine. This is derived from the ability of cells, particularly stem cells, to promote cell repair by reducing inflammation which promotes faster healing, better circulation and less pain in an injured area.

Stem cells can be taken from a variety of tissues in the body, and they tend to be harvested from areas that are easily accessible. With stem cell therapy, you are able to use your bodys own repair team (cells) to heal an injured area.

In fact, stem cell therapy has been proven to regenerate tissue in the human body without the need for surgery or additional medication in certain conditions. It is useful for patients who are suffering from degenerative and chronic diseases, such as chronic pain, who are in search of medical treatments without surgical interference.

Image via iStock

Regenerative Medicine and Stem Cell Therapy are useful treatment options for:

The typical patient is over 40 years perhaps starting to experience some joint pains, sexual dysfunction or lack of energy aging with an inability to keep up with their demanding lifestyles.

One patient, DG, came in for a list of concerns that are typical in a 60-year-old including knee pain, mild erectile dysfunction and high blood pressure.

One patient reported improved eyesight among other benefits after his treatment. Image via iStock

DG underwent stem cell therapy and reports to us on his experience. He reported an overwhelming relief from pain and the anxiety associated with expecting this pain. His knee, which was injured during an uphill walk, has had improvement and he is able to enjoy his daily walks without expectation of pain. He also marveled at the maintenance of life and health aspect of Stem Cell Therapy which enabled him to bank his extracted Stem Cells for future usage.

Lastly, DG mentioned the unexpected benefits that have come from the treatment such as improved eyesight without glasses, a reduction of graying hairs, a reduction in bags under the eye, a younger appearance and a reduction of Erectile Dysfunction!

BioRegeneration Integrated Medical Centre in Jamaica specialises in stem cell therapy using your own stem cells. This treatment is done locally by Dr Janice Simmonds-Fisher who has pioneered Regenerative Medicine in Jamaica for over a decade providing a life-improving treatment that enjoys over 90 per centsuccess rate in our population.

BioRegeneration is located at 15 Haining Road, Kingston. They can be contacted at 876-552-6484. For any questions, email questions@drjanicefisher.com or visit http://www.stemcelljamaica.com.

For our regional patients, Dr. Fisher offers phone or virtual consultations. To make a virtual consultation appointment, please email questions@drjanicefisher.com or whatsapp 876-565-1168.

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Regenerative Medicine: An alternative to surgery and pills | Loop Cayman Islands - Loop News Cayman

Building Europes gene therapy ecosystem POLITICO

By Gene Therapy Clinics

Gene therapy is a transformative field of medicine that could halt diseases before patients become symptomatic, saving lives and improving quality of life for millions of people who suffer from conditions caused by genetic abnormalities1. But these breakthrough treatments require new approaches to pricing and reimbursement2.

While the science behind gene therapy has existed for decades, the first generation of treatments is now emerging for debilitating conditions including spinal muscular atrophy3 and inherited retinal diseases4 5. Although Europe was at the forefront6 of science a decade ago, other regions have invested heavily in research and Europe has work to do to re-gain7 its leadership role.

A cell is the fundamental biological building block of all living things8. Genes, found within cells, are small sections of DNA that carry the cells genetic information. Genes are the cells blueprint for making proteins that support functions such as muscle strength, and mutations in genes contribute to a range of diseases including those caused by recessive gene disorders, like hemophilia and sickle cell anemia, acquired genetic diseases such as certain cancers, and some viral infections like AIDS9.

Gene therapies improve and/or replace mutated genes, most often via the technique of recombinant DNA technology in which a molecular carrier known as a vector is used to carry a healthy copy of the gene and introduce the new genetic material into the cell11. Most commonly, gene therapy allows cells to add an additional genetic unit, but new engineering techniques now exist to switch off, allow modification to or correct the problematic DNA sequence12.

Europes gene therapy leadership

Academic researchers, biotech and pharmaceutical companies in Europe have been instrumental in developing the field of gene therapy13. Between 2017 and 2019, the lead author of 120,000 papers in cell and gene therapy (CGT) publications was affiliated with a European institution, compared to 72,000 and 100,000 in the U.S. and China respectively14. Professor Emmanuelle Charpentier at the Max Planck Unit for the Science of Pathogens in Berlin was a joint winner of the Nobel Prize in Chemistry 2020, a recognition of her contribution to the development of tools for gene editing15.

The European Unions medical regulatory institution, the European Medicines Agency (EMA), has been a world leader in assessing advanced therapy medicinal products (ATMPs), a class of innovative biological products of which gene therapy is part, approving a tissue-engineering product in 2009, a year before the U.S.s first ATMP approval16. It also approved the worlds first gene therapy in 201216. The EMA has granted orphan drug status to the majority of CGT drugs currently in development and performed accelerated assessments for a number of cell and gene therapies14.

But the region needs to build on its momentum to take gene therapy from the lab to patients. The total number of gene-, cell- and tissue-based therapeutic developers worldwide lags behind the North American and Asia-Pacific regions17.

Europes gene therapy sector could be boosted by introducing more flexibility and agility to the methodologies that are used to evaluate and reimburse breakthrough treatments.

Because the diseases that cell and gene therapies are aimed at are rare, trials are conducted in a far smaller number of patients than is normal for a new medicine. Decisions to license the treatment will be based on the data from one small trial7.

Health Technology Assessment (HTA) bodies, who ultimately determine whether a new therapy is reimbursed, expect to review randomized controlled trials against a standard of care18. Yet gene therapies are a new approach that can effectively intercept, rather than manage, a disease and there is therefore no standard of care to compare against19.

Cost-effectiveness is commonly evaluated based on the direct financial burden of a disease on the health system18. Yet many genetic diseases biggest impact is indirect inherited blindness, for instance, is costly for the individual, their family and carers, and most costs are borne in the social and welfare system, rather than in clinics and hospitals20. One review by Deloitte estimated the total cost attributable to inherited retinal diseases at 523.3 million in 2019, across economic and wellbeing costs (see chart). Health system costs were the lowest share20.

Gene therapies that have the potential to intercept a disease entirely, are more difficult to quantify in terms of benefits19. Conventional HTA methods discount a benefit over time as a patients quality of life deteriorates due to aging and its other attendant health consequences21. This makes little sense in the case of a gene therapy that can avoid blindness emerging in a young person, say, thereby allowing them to lead a full and active adult life21.

Unlike rare disease treatments that are regularly administered over decades, gene therapy would be administered only once, providing many years, if not a lifetime, of biological activity and clinical benefit2. Under current reimbursement systems, this therapy would be paid once at the time it is administered. To encourage investment in the development of these therapies, payments in excess of $1 million may be needed2. The fact that one intervention can provide a cure, replacing long-term costs of treatment, makes investment in gene therapy a problem that multiple stakeholders need to work together to solve2. The industry is developing new approaches to pricing and reimbursement, such as outcome-based payment models22, orannuity payments23 based upon duration and efficacy, which could help payers accommodate the one-time nature of gene therapies.

Europe is already moving towards a coordinated response to review the challenges of breakthrough therapies. In December 2021, Europes Regulation on Health Technology Assessment was adopted to help member states to make timely and evidence-based decisions on patient access to innovative health technologies24. Gene therapies are amongst the medical breakthroughs that European reform dialogue is focused on to address unequal access across the continent25.

Building on this momentum can bring forth the required change to value assessment methodologies and help to realize the full potential of gene therapies. It will ensure gene therapy, long confined to research laboratories, can finally reach patients, and open a new chapter in medical history21.

Follow our journey at https://www.politico.eu/evolution-of-health-care/

References

1Mayo Clinic Staff. (2017). Gene Therapy. Available at:https://www.mayoclinic.org/tests-procedures/gene-therapy/about/pac-20384619

2Brennan, T. and Wilson, J. (2014). The special case of gene therapy pricing. Available at:https://www.nature.com/articles/nbt.3003

3Vamshi K. et al. (2018). Gene Therapy for Spinal Muscular Atrophy: An Emerging Treatment Option for a Devastating Disease. Available at: https://www.jmcp.org/doi/pdf/10.18553/jmcp.2018.24.12-a.s3

4EMA Europe. (2018). Luxturna, European Medicines summary of product characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/luxturna-epar-product- information_en.pdf

5Maldonado, R. et al. (2020). Curative gene therapies for disease. Available at: https://link.springer.com/article/10.1007/s12687-020-00480-6

6Cressey, D. (2012). Europe Nears First Approval for Gene Therapy Treatment. Available at: https://www.scientificamerican.com/article/europe-nears-first-approval-gene-therapy-treatment/

7Collis, H. (2022). Patients with rare diseases hope for Brexit hastened treatments. Available at: https://www.politico.eu/article/uk-gene-cell-therapy-brexit-science-research-rare- diseases/

8NCBI. (1989). The Fundamental Biological Unit of All Living Organisms is the Cell. Available at: https://www.ncbi.nlm.nih.gov/books/NBK217797/

9NCBI. (2017). Gene therapy: advances, challenges and perspectives. Available at:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5823056/

10American Society of Gene + Cell Therapy. (2021). Gene, Cell, & RNA Therapy Landscape. Available at: https://asgct.org/global/documents/asgct-pharma-intelligence-quarterly-report-july-20.aspx?_zs=sisac&_zl=Uu4h2

11Britannica. (2022). Recombinant DNA Gene therapy. Available at:https://www.britannica.com/science/recombinant-DNA-technology/Gene-therapy

12Medline Plus. (2022). What is gene therapy?. Available at:https://medlineplus.gov/genetics/understanding/therapy/genetherapy/#:~:text=A%20newer%20technique%2C%20called%20genome,existing%20DNA%20in%20the%20cell

13AuWerter, T. et al. (2020). Biopharma portfolio strategy in the era of cell and gene therapy. Available at: https://www.mckinsey.com/industries/life-sciences/our-insights/biopharma-portfolio-strategy-in-the-era-of-cell-and-gene-therapy

14Loche, A. et al. (2021). A call to action: Opportunities and challenges for CGTs in Europe. Available at: https://www.mckinsey.com/industries/life-sciences/our-insights/a-call-to-action-opportunities-and-challenges-for-cgts-in-europe

15Rogers, K. (2020). Emmanuelle Charpentier. Available at: https://www.britannica.com/biography/Emmanuelle-Charpentier

16NCBI. (2019). Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States. Available at:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6728416/

17Alliance for Regenerative Medicine. (2022). Regenerative Medicine: Disrupting the status quo. Available at:http://alliancerm.org/wp-content/uploads/2022/03/ARM_AR2021_FINAL-singles.pdf

18EUPATI. (2022). HTA systems in Europe. Available at: https://toolbox.eupati.eu/resources/hta-systems-in-europe/

19Pochopie M et al. (2021). An overview of health technology assessments of gene therapies with the focus on cost-effectiveness models. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592603/

20Deloitte Access Economics & Retina International. (2019). The socio-economic impact of inherited retinal dystrophies (IRDs) in the United Kingdom. Available at: https://www2.deloitte.com/content/dam/Deloitte/au/Documents/Economics/deloitte-au-economics-cost-illness-irds-uk-030919.pdf

21Salzman, R. et al. (2018). Addressing the value of gene therapy and enhancing patient access to transformative treatments. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6277509/

22Jrgensen, J. and Kefalas, P. (2019). The use of innovative payment mechanisms for gene therapies in Europe and the USA. Available at: https://www.futuremedicine.com/doi/10.2217/rme-2020-0169

23Cook, F. et al. (2018). Regenerative Medicine is Here: New Payment Models Key to Patient Access. Available at: https://alliancerm.org/wp-content/uploads/2018/07/ARM_WhitePaper3_IV1807_LRS.pdf

24HTA Regulation Press. (2021). Health Technology Assessment: Commission welcomes the adoption of new rules to improve access to innovative technologies. Available at: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6771

25Cornetta, K. et al. (2022). Gene therapy access: Global challenges, opportunities, and views from Brazil, South Africa, and India. Available at: https://www.sciencedirect.com/science/article/pii/S1525001622002301

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Building Europes gene therapy ecosystem POLITICO

FDA approval brings first gene therapy to the United States

By Gene Therapy Clinics

For Immediate Release: August 30, 2017

This release was updated on Aug. 30, 2017 to correctly identify the FDA designations granted to Kymriah.

Espaol

The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.

The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

Were entering a new frontier in medical innovation with the ability to reprogram a patients own cells to attack a deadly cancer, said FDA Commissioner Scott Gottlieb, M.D. New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses. At the FDA, were committed to helping expedite the development and review of groundbreaking treatments that have the potential to be life-saving.

Kymriah, a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.

Kymriah is a genetically-modified autologous T-cell immunotherapy. Each dose of Kymriah is a customized treatment created using an individual patients own T-cells, a type of white blood cell known as a lymphocyte. The patients T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells.

ALL is a cancer of the bone marrow and blood, in which the body makes abnormal lymphocytes. The disease progresses quickly and is the most common childhood cancer in the U.S. The National Cancer Institute estimates that approximately 3,100 patients aged 20 and younger are diagnosed with ALL each year. ALL can be of either T- or B-cell origin, with B-cell the most common. Kymriah is approved for use in pediatric and young adult patients with B-cell ALL and is intended for patients whose cancer has not responded to or has returned after initial treatment, which occurs in an estimated 15-20 percent of patients.

Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research (CBER). Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that has shown promising remission and survival rates in clinical trials.

The safety and efficacy of Kymriah were demonstrated in one multicenter clinical trial of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor ALL. The overall remission rate within three months of treatment was 83 percent.

Treatment with Kymriah has the potential to cause severe side effects. It carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR T-cells causing high fever and flu-like symptoms, and for neurological events. Both CRS and neurological events can be life-threatening. Other severe side effects of Kymriah include serious infections, low blood pressure (hypotension), acute kidney injury, fever, and decreased oxygen (hypoxia). Most symptoms appear within one to 22 days following infusion of Kymriah. Since the CD19 antigen is also present on normal B-cells, and Kymriah will also destroy those normal B cells that produce antibodies, there may be an increased risk of infections for a prolonged period of time.

The FDA today also expanded the approval of Actemra (tocilizumab) to treat CAR T-cell-induced severe or life-threatening CRS in patients 2 years of age or older. In clinical trials in patients treated with CAR-T cells, 69 percent of patients had complete resolution of CRS within two weeks following one or two doses of Actemra.

Because of the risk of CRS and neurological events, Kymriah is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring that hospitals and their associated clinics that dispense Kymriah be specially certified. As part of that certification, staff involved in the prescribing, dispensing, or administering of Kymriah are required to be trained to recognize and manage CRS and neurological events. Additionally, the certified health care settings are required to have protocols in place to ensure that Kymriah is only given to patients after verifying that tocilizumab is available for immediate administration. The REMS program specifies that patients be informed of the signs and symptoms of CRS and neurological toxicities following infusion and of the importance of promptly returning to the treatment site if they develop fever or other adverse reactions after receiving treatment with Kymriah.

To further evaluate the long-term safety, Novartis is also required to conduct a post-marketing observational study involving patients treated with Kymriah.

The FDA granted Kymriah Priority Review and Breakthrough Therapy designations. The Kymriah application was reviewed using a coordinated, cross-agency approach. The clinical review was coordinated by the FDA's Oncology Center of Excellence, while CBER conducted all other aspects of review and made the final product approval determination.

The FDA granted approval of Kymriah to Novartis Pharmaceuticals Corp. The FDA granted the expanded approval of Actemra to Genentech Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukemia

Andrea Fischer 301-796-0393

Angela Stark 301-796-0397

888-INFO-FDA, OCOD@fda.hhs.gov

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FDA approval brings first gene therapy to the United States

Hope For Leukemia Patients, Where Other Treatments Have Failed – Longevity LIVE – Longevity LIVE

By Gene Therapy Clinics

Two experts from Cleveland Clinic explain how a new cell-based gene therapy is helping patients with certain types of leukemia, with research into potential wider applications continues.

As World Leukemia Day approaches on 4 September, experts from global health system Cleveland Clinic are working on new immunotherapy treatments for blood cancers such as leukemia, expanding treatment options and bringing hope to patients for whom other treatments have failed.

Leukemia is a group of cancers characterized by rapid, uncontrolled growth of abnormal blood cells called leukemia cells. It can occur in children and adults and according to the World Cancer Research Fund International, it is the 13th most prevalent cancer globally.

According to Jan Joseph Melenhorst, PhD, a translational immunologist who is Director of Cleveland Clinics recently established Cell Therapy and Immuno-Engineering Program, chimeric antigen receptor (CAR) T-cell therapy is profoundly changing the treatment landscape, bringing the promise of durable remission for many patients with blood cancers such as leukemia.

Dr-Jan Joseph-Melenhorst

CAR T-cell therapy is a specialized treatment using a patients own T-cells a type of white blood cell that forms part of the immune system.

The T-cells are extracted and genetically modified so that they can recognize and destroy cancer cells, before being multiplied and infused back into the bloodstream, explains Dr. Melenhorst, who is also Vice Chair of the Center for Immunotherapy and Precision Immuno-Oncology at Cleveland Clinic.

He added that while CAR T-cell therapy has brought new hope for many patients, there are currently several challenges to overcome in administering the treatment.

In particular, it may be more expensive than other therapies. Additionally, it has potentially serious side effects.

This limits access to treatment as the therapy needs to be administered on an inpatient basis at a specialized facility where the side effects can be managed. We are working with Clevelands Case Western Reserve University and other parties and collaborating with various manufacturers to address issues such as accessibility, safety, and costs, he says.

Dr. Melenhorst and his team are also aiming to improve the efficacy of existing CAR T-cell therapies while developing new versions for a wide range of blood and other cancers.

Their colleague, Craig Sauter, MD, is a hematologist and Director of Blood and Marrow Transplant at the Cleveland Clinic who has been using CAR T-cell therapy to successfully treat patients with leukemia and other blood cancers where other treatments have failed.

The standard of care in initial therapy for many acute leukemia patients remains cytotoxic chemotherapy, with the aim of achieving remission. In cases where first-line chemotherapy or other treatments have failed, however, CAR T-cells provide another potential treatment option for patients with B-cell acute lymphoblastic leukemia. In the FDA-approved indications, it has proved much more effective than the previous standard, which was a further round of chemotherapy, he says.

The U.S. Food and Drug Administration (FDA) has approved commercial CAR T-cell products for several types of blood cancers including acute lymphocytic leukemia (ALL) in patients who have been resistant to other treatments or whose cancer has returned after a period of remission. Clinical trials are also underway at institutions including Cleveland Clinic for CAR T-cells to treat acute myeloid leukemia (AML).

ALL and AML are two of the four main types of leukemia. The disease is classified as acute or chronic based on how rapidly the disease spreads in the body, and as myeloid or lymphocytic depending on whether the leukemia cells arise from myeloid cells, which develop in bone marrow, or from lymphoid cells, which are related to the immune system.

Dr. Craig Sauter

Explaining how the procedure works in practice,

Dr. Sauter says the first step is to extract the patients lymphocytes and insert an inactive virus that delivers new genetic instructions to the T-cells to start producing chimeric antigen receptors targeting proteins that live on the malignant cells.

Researchers take a small batch of these newly altered CAR T-cells and induce them to grow and multiply until there are enough to effectively target cancer cells.

The CAR T-cells are frozen and stored until the patient is ready to receive them. To prepare for the infusion, the patient receives a mild form of chemotherapy to prevent the immune system from rejecting the CAR T-cells.

According to Dr. Sauter, most people need to stay in the hospital for one to two weeks so their response to the treatment can be monitored and any side effects treated. The two most common side effects of CAR T-cell therapies are cytokine release syndrome (CRS) and neurological problems such as headaches, confusion, or difficulty speaking during the treatment period.

Dr. Sauter points out CAR T-cell therapy is in its early phase, but he is cautiously optimistic about its potential. In future, as a result of further research and carefully conducted studies, there may be an opportunity to identify high-risk groups who may benefit from having CAR T-cell therapy over chemotherapy in earlier lines of treatment, he says. The possibility of its application being extended to treat other forms of cancer is also very exciting.

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States.

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Hope For Leukemia Patients, Where Other Treatments Have Failed - Longevity LIVE - Longevity LIVE

Stem Cell – Genome.gov

By Stell Cell Research

A stem cell is a specific type of cell in the body that has the potential to form many different cell types. So stem cells generally are undifferentiated, and then the kind of cells that they make would become the more mature cells that you're familiar with. So generally, if you think about it, stem cell is the top brick in a big pyramid, and at the base of the pyramid are maybe four different kinds of cells that are derived from that stem cell. And you can see that not only do they mature as they head down the pyramid, but they get greater in number. So a very small number of stem cells can give rise to an enormous number of mature progeny. Now, there are several different kinds of stem cells. There are somatic stem cells. These are the ones that live in the adult organism. And people have stem cells in their bone marrow that give rise to all the different kinds of blood that they have. There are stem cells in the liver that give rise to hepatocytes and secretory cells. There are stem cells in neural tissue that give rise to neurons and astroglial cells and things like that. And muscle has stem cells. And there are many different kinds of stem cells that have been identified in adults. There are also embryonic stem cells, and these are derived from three and a half days in the mouse and about six- to eight-day embryos in people, and these are cells with even more potential than the adult cells, because an embryonic stem cell derived in the proper way can give rise to neural cells, muscle cells, and liver cells. And these are the three different general parts of an organism that happens during its development. So the very important thing to remember about stem cells is they need not only divide and proliferate to make these many, many mature progeny cells, they also need to assure that their own stem cell pool is not reduced. So it's kind of like if you're getting three wishes, your last wish should be for more wishes. So what stem cells do is they have two different kinds of divisions they can make. They can make what's called a symmetric division, where the stem cell divides and both cells stay undifferentiated in stem cells. Or they can make asymmetric division, in which one cell goes on to proliferate and differentiate into the progeny, and the other cell stays a stem cell. So in periods like after a bone marrow transplant, where the stem cell number has to expand, they make many more symmetric than asymmetric divisions. But in the regular time in your bone marrow, the stem cells make mostly asymmetric divisions, which keep the number of stem cells pretty standard.

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Stem Cell - Genome.gov

11 Stem Cell Research Pros and Cons Vittana.org

By Stell Cell Research

Stem cell research can be classified into two specific areas: embryonic stem cells and non-embryonic stem cells. Amniotic, induced pluripotent, and adult stem cells do not involve the creation or destruction of a human embryo to have them collected.

Even embryonic stem cells can be collected, to some extent, without the destruction of an embryo. Modern collection techniques include using stem cells that are found in the umbilical cord, in breast milk, or even in bone marrow.

The primary benefit of stem cell research is its clear potential. Since 1868, the idea of using stem cells as a medical treatment has been contemplated in one way or another, especially as we began to understand their full potential. With stem cell therapies, we have the potential to treat injuries, degenerative conditions, or even a genetic disease or disorder.

As for the primary disadvantage of stem cell research, the ethics of collecting embryonic stem cells tends to dominate the conversation. To some people, the idea of destroying an embryo to harvest cells equates to murder. For others, they see the hundreds of thousands of frozen embryos, many of which are simply thrown away after being stored for too long, as wasted potential.

Here are some additional stem cell research pros and cons to review.

1. It could treat several conditions that are virtually untreatable right now. Stem cell research opens numerous avenues for treatments or a cure to be found for several conditions that are either untreatable or without a cure today. Everything from Alzheimers disease to Parkinsons disease to ALS could be improved. People who have a spinal cord injury could receive an injection of stem cells and potentially start the recovery process. Even mental health issues, such as schizophrenia, could one day be treated with stem cell applications.

2. It provides us with greater knowledge. By researching stem cells, we understand more about the growth process of humans. We learn more about how cells form and interact with one another. We can examine pluripotent cells, both induced and embryonic, to see what information is required for them to turn into a specific tissue cell. With a greater understanding of this micro-environment, we can learn more about who we are at our very core.

3. It offers new methods of testing. When new medical treatments are proposed, they must go through multiple stages of testing. This includes animal trials and human trials, which may or may not be successful. As our knowledge of stem cells grows, we could transition testing methods so that only cell populations are examined for a response instead of an innocent animal or a paid human research contributor. That may improve safety, reduce fatalities, and even speed up the approval process.

4. It reduces the risk of rejection. Many stem cell therapies today use the cells that are collected from a patients body. Because the cells are their own, the risk of rejection is reduced or even eliminated. If stem cells could be induced to form into organ tissues, such as a kidney, then the science of organ transplantation could be forever changed. Imagine growing a kidney that is a genetic match instead of trying to find a donor organ that could be rejected, even if a direct match is found. That is the potential of this medical research.

5. It could stop birth defects and mutations before they happen. By understanding the process of stem cell development, it could be possible to change the embryonic development process. Chromosomal concerns, birth defects, and other errors in development could be corrected before birth, giving more newborns a real chance to experience the gift of life. At the same time, the risks of pregnancy loss and health risks to new mothers could be decreased.

1. We have no idea about long-term side effect issues. According to the Canadian Cancer Society, there are several common short-term side effects that are associated with stem cell therapies. They may include infection, bleeding, skin or hair problems, unexplained pain, organ problems, or even the development of a secondary cancer. Every medical treatment provides some risk of a side effect, but this medical technology is so new that we have no idea what the long-term health effects might be.

2. It provides a health risk to everyone involved. Collecting stem cells from an adult carries a medical risk with it. Something could go wrong during the collection process that may reduce the quality of life for the patient. Their life could even be placed at-risk. For embryonic collection, the destruction of the blastocytes that are formed during egg fertilization is required. Since the embryo is technically a different form of human life, there will always be the chance of rejection occurring since the cells are not ones own.

3. Adult stem cells offer limited potential. Our current stem cell research findings indicate that adult stem cells that have already transitioned into specific tissues or formats because of their body location will stay that way. That means stem cells taken from muscle tissue would only be able to create additional muscle tissues. Even if they are induced to be pluripotent, the end result tends to be duplication instead of identification because they have a determined type.

4. It is still an unproven medical technology. There is a lot of hope for stem cell treatments. Hematopoietic stem cell transplantation is performed about 50,000 times annually around the world and the success rate for the treatment is climbing above 90%. Because some forms of stem cell research are classified as illegal or immoral in the United States, however, progress to improve treatments or prove the effectiveness of this medical technology are not as advanced as their potential.

5. It isnt cheap. Stem cell therapies are far from affordable. Because most health insurers classify this type of treatment as experimental, it is rarely a covered procedure. Most treatments that are approved for use in the US cost more than $10,000 per procedure. Some treatment options are six figures. Even the cost of harvesting stem cells from an embryo is a couple thousand dollars. Access to this technology is restricted to socioeconomic means globally and to almost everyone in the United States.

6. Opportunities are limited. Although stem cell research isnt technically forbidden in the US, there are just 19 stem cell lines available for government grants and funding thanks to legislative restrictions that are enacted in 2001. Certain states have begun to draft legislation to completely ban stem cell research, or at least embryonic stem cell research, or at least place major restrictions on the process.

We should examine the ethics of embryonic stem cell research, but we should also examine the benefits it may provide. Adult stem cells, collected from consenting parties, should have no criticism whatsoever. As we move forward in this research, new pros and cons may also require additional contemplation. One thing is for certain: these stem cell research pros and cons show us that humanity is complex, beautiful, and wonderful in many ways.

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11 Stem Cell Research Pros and Cons Vittana.org

Rise In Number Of CROS In Various Regions Such As Europe Is Expected To Fuel The Growth Of Induced Pluripotent Stem Cell Market At An Impressive CAGR…

By Stell Cell Research

Rise In Research And Development Projects In Various Regions Such As East Asia, South Asia Are Expected To Offer An Opportunity Of US $ 0.5 Bn In 2022-2026 Period.

Fact.MR A Market Research and Competitive Intelligence Provider: The global induced pluripotent stem cell (iPSC) market was valued at US $ 1.8 Bn in 2022, and is expected to witness a value of US $ 2.3 Bn by the end of 2026.

Moreover, historically, demand for induced pluripotent stem cells had witnessed a CAGR of 6.6%.

Rise in spending on research and development activities in various sectors such as healthcare industry is expected to drive the adoption of human Ips cell lines in various applications such as personalized medicine and precision.

Moreover, increasing scope of application of human iPSC cell lines in precision medicine and emphasis on therapeutic applications of stem cells are expected to be driving factors of iPSC market during the forecast period.

Surge in government spending and high awareness about stem cell research across various organizations are predicted to impact demand for induced pluripotent stem cells. Rising prevalence of chronic diseases and high adoption of stem cells in their treatment is expected to boost the market growth potential.

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Besides this, various cells such as neural stem cells, embryonic stem cells umbilical cord stem cells, etc. are anticipated to witness high demand in the U.S. due to surge in popularity of stem cell therapies.

Key Takeaways:

Growth Drivers:

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Competitive Landscape:

Many key players in the market are increasing their investments in R&D to provide offerings in stem cell therapies, which are gaining traction for the treatment of various chronic diseases.

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Neukio Biotherapeutics completed Series A-1 financing, to accelerate discovery and development of next generation cell therapy products – PR Newswire

By Stell Cell Research

SHANGHAI, Sept. 2, 2022 /PRNewswire/ -- Neukio Biotherapeutics, a company committed to developing novel cell therapy products, announces it has closed$50 million in a Series A-1 funding round. The investment round was led by CD Capital, with the participation of Alwin Capital and Surplus Capital as new investors. Existing shareholders Lilly Asia Ventures, Sherpa Healthcare Partners and IDG Capital have continued to support the company with additional funding. G&G Capital served as the exclusive financial adviser. The funds raised will play important roles in accelerating the preclinical and clinical validation of induced pluripotent stem cell (iPSC)-derived off-the-shelf CAR-NK cell therapy products, and supporting team recruitment and expansion.

Neukio, founded at the Simbay Park in Shanghai Pilot Free Trade Zone (China) in June 2021, is an innovative biotherapeutic company focusing on the development and commercialization of next generation immune cell therapy. Leveraging its significant experience in the R&D, CMC and commercialization of autologous CAR-T cell therapy, Neukio's management team has established an iPSC-CAR-NK-based pipeline development strategy, aiming to launch allogenic off-the-shelf cell therapy products that can be produced in scale for treating solid tumors. The company focuses on both in-house R&D innovation and global collaboration with leading partners, to provide valuable clinical solutions for cancer patients worldwide. Since its establishment just over one year ago, the company has made remarkable progress in talent recruitment, facility construction, R&D pipeline advancement and quality management system establishment, exceeding all expectations.

Dr. Richard Liqun Wang, founder, chairman and CEO of Neukio and former founding CEO of Fosun Kite Biotechnology Co., Ltd., has successfully broughtChina's first CAR-T cell therapy product Yescarca (Axicabtagene Ciloleucel) to the market in less than four years, laid foundation for the cell therapy industry in China. To address the challenges in manufacturing, clinical application, and patient access of autologous cell therapy, Dr. Wang and the Neukio team are aiming high to create novel cell therapies for the benefit of cancer patients by exploiting the clonality and unlimited replication capability of iPSCs in conjunction with cutting-edge gene editing technologies.

Dr. Wang commented: "In as little as 10 months since the operation of our new laboratories, not only have we completed several signaling pathway modifications and CAR designs tailored for solid tumors, but also we have made significant progress in the development of innovative manufacturing processes of NK differentiation and expansion. In today's challenging environment of capital market, we are honored to have received recognition from CD Capital, Alwin Capita, Surplus Capital, and previous investors of Sherpa Healthcare Partners, Lilly Asia Ventures and IDG Capital on our R&D strategy, development capabilities and project progress. I am very grateful to all investors and to G&G Capital and Silkroad Law Firm for their support in this round of financing, and we will reward them with rapidly moving forward in the preclinical and clinical validation of our R&D platform and products. The field of cell therapy is rapidly advancing with a promising future and a huge market potential, and iPSC-CAR-NK therapy has the potential to become one of the brightest stars of next generation cell therapy."

"The transition from traditional small molecules and antibodies to the era of cell therapy is a great leap in drug design and manufacturing capabilities of human being," said CD Capital, the leading investor in this round of financing. "With the commercialization of autologous CAR-T cell products, more and more improvement opportunities have emerged and need to be taken urgently. In the field of cell therapy, CD Capital continues to focus on innovations and breakthroughs in allogenic products to conquer solid tumors. Neukio has been deeply committed to iPSC-CAR-NK cell therapy. Within a short time of its establishment, Neukio has built up global leading technology platforms efficiently in both scientific innovation and process development, demonstrating its strong execution capability and efficiency. We hope that the company, under the leadership of Dr. Wang, will adhere to pragmatism, efficiency, and innovation, leading the advancement of the industry, and bringing a new generation of allogenic cell therapy products to the clinical application as soon as possible for the benefit of patients."

About CD Capital

CD Capital is an investment organization focusing on innovative medical technologies and cutting-edge biotechnologies. Run by a professional team with senior medical industry background, it is managing multiple USD and RMB funds. By adhering to the investment philosophy of "focus, excellence, and reputation" and by leveraging its abundant industrial resources and years of in-deep research and cultivation in the medical field, CD Capital is able to get first-hand insight into the latest international scientific and technological trends and seize the investment opportunities brought by technological innovation. CD Capital is committed to identifying top enterprises with leadership potential in the industry, builds an industrial ecosystem and grows together with entrepreneurs through the interconnected and win-win investment methodology and a precise and pragmatic post-investment empowerment system, and creates sustainable and excellent returns for investors.

About Alwin Capital

Focusing on the frontier areas of life sciences, Alwin Capital conducts in-deep research, unifies knowledge and practice, walks in non-consensus areas, and invests objectively and truthfully in real opportunities for medical transformation. With a core team formed by the veterans in both industry and capital market, Alwin Capital believes in the power of research, is committed to long-term investment, steadily builds the enterprise ecology, and strives to obtain systematic excess returns for investors.

About Surplus Capital

Surplus Capital is committed to discovering and supporting medical enterprises that promote the health of all humankind. It focuses on subdivision areas such as innovative drugs and innovative medical devices, and adopts diversified investment strategies to pay attention to all stages of enterprise development, including start-up, growth and maturity. Surplus Capital also cultivates seed-stage project sources, and invests and assists in the incubation of high-quality seed-stage projects to help enterprises create value.

About Lilly Asia Ventures

Founded in 2008, Lilly Asia Ventures (LAV) is a leading venture fund firm focusing on investment in the life sciences and healthcare sectors with offices in Shanghai, Hong Kong, and Silicon Valley. LAV is committed to being a trusted partner for exceptional entrepreneurs seeking smart capital, and looks forward to working with top entrepreneurs to build great companies developing breakthrough products that treat diseases and improve human health.

About Sherpa Healthcare Partners

Sherpa Healthcare Partners (Sherpa) is a professional fund firm focusing on early-stage medical and health investment. It adheres to the investment concept of building industry ecology, builds portfolios for rigid unmet medical needs on the basis of in-depth understanding of the treatment of critical diseases, and plans the layout along the industry depth and upstream and downstream. By actively sharing operational experience and forward-looking perspectives of the whole industrial chain with the invested enterprises, the team from Sherpa actively promotes internal and external synergy, helping enterprises achieve rapid growth in both business performance and value and take a leading position in their market segments. It has invested in leading enterprises in such subdivisions as medical services, medicine, genetic technology and medical devices, forming a full range of resource advantages in project sources, post-investment value-added services, exits, etc. From 2011 to 2022, after 4 fund years and more than 100 medical projects, Sherpa has grown up hand in hand with many outstanding entrepreneurs.

About IDG Capital

IDG Capital pioneered the venture capital business in China in 1993. For years, IDG Capital consistently pursues long-term value investment and maintains long-term close relationships with diverse investment partners from around the world. IDG capital has accumulated extensive investment experience in venture capital, private equity and industrial development. It has the following areas of focus, including consumer goods, chain services, Internet and wireless applications, new media, education, health care, new energy, advanced manufacturing, etc. The investment covers companies at all stages of development: start-up, growth, maturity and pre-IPO, with a size of investment ranging from millions to tens of millions of U.S. dollars.

For more information and updates on Neukio Therapeutics, please visit the company's website at http://www.neukio.com.

SOURCE Neukio Biotherapeutics

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Neukio Biotherapeutics completed Series A-1 financing, to accelerate discovery and development of next generation cell therapy products - PR Newswire

Novel Method Accelerates the Immune Cell Production Pipeline – Technology Networks

By Stell Cell Research

A University of British Columbia research team has developed a new, fast, efficient process for producing cancer-fighting immune cells in the lab. The discovery could help transform the field of immune cell therapy from an expensive, niche endeavour to something easily scalable and broadly applicable.

Weve figured out the minimal necessary steps to efficiently guide pluripotent stem cells to develop in the dish into immune cells, in particular, T cells, said Dr. Yale Michaels, referring to the most essential cells of the human immune system. One of the next steps were working on is to scale this up and make it work more efficiently so that we can make enough cells to treat patients.

The breakthrough paper, published last week in Science Advances by Dr. Michaels, PhD student John Edgar, and a team from Dr. Peter Zandstras lab at UBCs Michael Smith Laboratories and School of Biomedical Engineering, describes a novel method that is now the fastest known way to produce T cells in the lab.

T cells are instrumental in CAR T therapy, a well-known and successful cancer treatment that involves obtaining immune cells from the patient, genetically modifying them to fight against the patients cancer and infusing them back into the patients body to fight the disease. Although this type of therapy has an efficacy rate of close to 50 per cent for some cancers, a new batch of medicine needs to be created for each treatment, costing roughly half a million dollars each round.

Because the main cost associated with these treatments is the fact that theyre made individually, a more cost-effective strategy could be figuring out how to manufacture those immune cells in the lab using stem cells, instead of taking them directly from a patient, explains Michaels.

Pluripotent stem cells have the ability to differentiate into any type of cell in the human body and can endlessly renew themselves. Using PSCs to create immune cells in the lab for therapeutic treatments means hundreds of doses of a medicine could be derived from a single cell.

Building on a large body of previous work in the area, Michaels, Edgar and a team from the Zandstra lab discovered that providing two proteins to stem cells during a key window of development improved the efficiency of immune cell production by 80 times. By working strictly with the proteins DLL4 and VCAM1, instead of the animal cells and serums that complicated previous methods, the production process becomes a carefully controlled pipeline that is easy to replicate.

The improvement of this production pipeline is one step among many towards solving a variety of human health challenges. How to scale up a cell differentiation process, how to make cells good at killing cancer and fighting against other immune diseases, and how to deliver them to patients in a safe way are all important questions being explored simultaneously by the Zandstra lab and other research groups.

Dr. Michaels acknowledged that the collective work of thousands of people, each making important contributions, enabled this project to succeed.

"People have made tremendous progress over the last 20 years and this breakthrough is an exciting continuum, he said.

The team hopes their new findings and ongoing work in the lab will contribute to future clinical pipelines.

Reference:Michaels YS, Edgar JM, Major MC, et al. DLL4 and VCAM1 enhance the emergence of T cellcompetent hematopoietic progenitors from human pluripotent stem cells. Sci Adv. 2022;8(34):eabn5522. doi: 10.1126/sciadv.abn5522

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Novel Method Accelerates the Immune Cell Production Pipeline - Technology Networks

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