Omisirge: A Groundbreaking Advancement in Cord Blood Stem Cell Treatment

Important Note: Americord is not affiliated with Gamida Cell or the Omisirge product. At this time, Americord does not release clients’ stored cord blood to Gamida Cell for clinical use. The information below is for informational purposes only.

The U.S. Food and Drug Administration (FDA) has recently granted its first-ever approval for the Gamida Cell product Omisirge, an innovative therapy that expands the number of cord blood stem cells used for treatment. This landmark decision not only revolutionizes the field of regenerative medicine, but also highlights the increasing importance of cord blood banking.

Omisirge is a groundbreaking therapy designed to enhance the functionality of cord blood stem cells. By utilizing a proprietary expansion process, it significantly increases the number of hematopoietic stem cells (HSCs) in a single unit of cord blood. When it comes to treatment, the higher volumes can potentially lead to a higher chance of successful engraftment of stem cells.

This expansion technique addresses one of the primary challenges faced in cord blood transplantation – the limited number of stem cells available for treatment. By expanding the number of stem cells, Omisirge can help improve transplant outcomes, reduce the time to engraftment, and decrease the risk of complications such as infections, GvHD, organ failure, and/or graft failure for patients.

Ultimately, the treatment has been developed after years of research, which focused on finding a way to multiply the number of HSCs in cord blood without compromising their ability to regenerate into various blood cell types. The result is a therapy with the potential to treat a wide range of life-threatening diseases, including leukemia, lymphoma, and various immune and metabolic disorders. This breakthrough has the potential to transform the field of cord blood transplantation, making it a more viable treatment option for a greater number of patients.

The FDA approval of Omisirge has far-reaching implications for stem cell treatments. Until now, cord blood stem cell transplants have been limited by the number of available cells. With Omisirge, however, the number of usable cells can be significantly increased, greatly improving the chances of successful treatment.

Additionally, this advancement may pave the way for treating a broader range of conditions that were previously considered unsuitable for cord blood transplants due to limited cell dose. This could lead to a wider acceptance of cord blood stem cell therapy in the medical community, making it a more mainstream treatment option.

The approval of Omisirge also underscores the importance of cord blood banking. As the demand for cord blood stem cell therapies grows, so does the need for a readily available supply of cord blood units. Families can contribute to this supply by opting to store their newborn’s cord blood in private or public cord blood banks.

Private cord blood banking allows families to store their child’s cord blood exclusively for their own use, ensuring that a compatible unit is available if the need for a transplant arises. Public cord blood banks, on the other hand, store donated cord blood units for the benefit of patients in need of a transplant who do not have a compatible family donor. However a major problem with public cord blood banks is the cost of retrieval and lack of diversity from donors. This makes it hard for some to find a match.

With the FDA approval of Omisirge, cord blood banking is becoming an increasingly vital resource in the fight against life-threatening diseases. By providing a larger pool of viable stem cell units for transplantation, cord blood banks play a crucial role in improving treatment outcomes and advancing the field of regenerative medicine.

However, it is important to note that the approval of Omisirge by the FDA does not automatically imply approval for specific patient cord use or guarantee treatment success for every individual. It is crucial to consult with a qualified healthcare professional before making any medical decisions or pursuing any treatments.

For expecting parents, these advancements in cord blood therapies emphasize the importance of considering cord blood banking. The potential life-saving benefits of cord blood transplantation are becoming increasingly clear, and with the introduction of Omisirge cord blood transplants are set to become even more effective and safer. By banking their baby’s cord blood, parents are investing in a potentially lifesaving resource for their child and others in need of a stem cell transplant.

As cord blood banking gains traction, the scientific community is likely to see a surge in interest and research into cord blood therapies. The success of Omisirge highlights the potential of cord blood as a valuable resource for treating various life-threatening diseases. Researchers and scientists will continue to explore new and innovative ways to harness the power of cord blood stem cells, leading to further advancements in the field.

In conclusion, the FDA approval of Omisirge marks a major milestone in the advancement of cord blood stem cell therapies. This groundbreaking treatment not only increases the potential of stem cell transplants, but also emphasizes the importance of cord blood banking as a valuable resource for combating debilitating diseases. As research continues, Omisirge may ultimately pave the way for even more innovative therapies in the realm of regenerative medicine. 

—

Disclosure:

The information provided in this article is for informational and educational purposes only and does not constitute medical advice or recommendations. The approval of Omisirge by the FDA does not automatically imply approval for specific patient cord use or guarantee treatment success for every individual. It is crucial to consult with a qualified healthcare professional before making any medical decisions or pursuing any treatments.

Americord will continue to closely monitor advancements in the cord blood banking industry and how they may help our current and future families. Our goal is to provide the most up-to-date and accurate information to help our families make informed decisions regarding stem cells and treatments. As new therapies and technologies emerge, we will provide updates and insights to ensure our families remain well-informed about the latest developments in the field.

References:

• FDA. FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation. News Release. Announced 2023-04-17 
• FDA. BLA Approval Letter to Gamida Cell. Released 2023-04-17 Verter F. Update on Omidubicel from Gamida Cell: Phase 3 Trial Outcomes. Parent’s Guide to Cord Blood Foundation News published 2021-03 
• Horwitz ME, Stiff PJ, Cutler C, et al. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood 2021; 138(16):1429-1440. 
• Eapen M, Rubinstein P, Zhang M-J, et al. Outcomes of transplantation of unrelated donor umbilical cord blood and bone marrow in children with acute leukaemia: a comparison study. Lancet 2007; 369(9577):1947-1954. 
• Bashey A, Zhang M-J, McCurdy SR, … Eapen M. Mobilized Peripheral Blood Stem Cells Versus Unstimulated Bone Marrow As a Graft Source for T-Cell–Replete Haploidentical Donor Transplantation Using Post-Transplant Cyclophosphamide. J Clinical Oncology 2017; 35(26):3002–3009. 
• Barker JN, Weisdorf DJ, DeFor TE, … Wagner Jr. JE. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood 2005; 105(3):1343–1347. 
• Milano F, Rezvani AR, Kurtzberg J, … Delaney C. No Engraftment Advantage after Single or Double Umbilical Cord Blood Transplant (CBT) with the Addition of a Non-HLA Matched Off-the-Shelf Expanded Cord Blood Unit Compared to Conventional CBT: Results of a Randomized Trial. Blood 2019; 134(S1):146. 
• Lin C, Schwarzbach A, Sanz J, … Horwitz ME. Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials. Transplantation and Cellular Therapy. Online Feb. 2023 
• Fuchs EJ. Related haploidentical donors are a better choice than matched unrelated donors: Point. Blood Advances. 2017; 1(6):397-400. 
• Gamida Cell. Gamida Cell Q4 2022 Financial Results Call. Webcast. Released 2023-03-27 
• Verter F, Bersenev A, Silva Couto P. Clinical Trials of Expanded Cord Blood. Parent’s Guide to Cord Blood Foundation News published 2018-05 
• Keenan J. Novartis-backed Gamida’s approval plans for cell therapy hits a snag with FDA asking for manufacturing data. Fierce Pharma. Published 2021-11-11 
• Armstrong A. Gamida Cell readies stem cell transplant therapy for FDA submission but seeks strategic partners amid staffing cuts. Fierce Biotech. Published 2022-01-31 
• Bayer M. FDA extends deadline to decide on Gamida Cell’s stem cell transplant therapy by three months. Fierce Biotech. Published 2022-01-31 
• Gamida Cell. Gamida Cell Appoints Abigail L. Jenkins as President and Chief Executive Officer, Bringing Broad Leadership Experience in Commercializing Innovative Therapies. Press Release. Announced 2022-09-19 
• Gamida Cell. Gamida Cell Announces Closing of $25 Million Financing With Highbridge. Press Release. Announced 2022-12-12 
• Gamida Cell. Gamida Cell Announces Changes to Board of Directors. Business Wire. Announced 2023-03-20 
• ISCT. Cell, Tissue and Gene Products with Marketing Authorization. Presidential Task Force List.Last updated 2021-09 

The views, statements, and pricing expressed are deemed reliable as of the published date. Articles may not reflect current pricing, offerings, or recent innovations.