The FDA made history in April with its first-ever approval of an expanded cord blood product for use as a primary treatment in hematopoietic stem cell transplants (HSCT) for certain blood cancers in adults and children 12 years of age and older.1
Why is cord blood expansion important?
For over 30 years, cord blood has been successfully utilized in rebuilding healthy blood and immune systems through a procedure known as HSCT.2
HSCTs using stem cells from cord blood offer significant advantages compared to using bone marrow or peripheral blood, especially in terms of flexibility with genetic matching and reduced risk of certain complications like chronic graft vs. host disease.2,3
However, one major challenge has been the limited volume of cord blood collected. Since stem cells are dosed based on a person’s body weight, cord blood collection volumes can sometimes fall short in providing an adequate number of stem cells, especially for adult patients requiring HSCT.
Cord blood expansion involves isolating and multiplying certain populations of cells found in cord blood for use in traditional transplants and advanced cell therapies. The goal of cord blood expansion is to help overcome some of the limitations of using cord blood in various treatments by increasing the available cell dose.
What’s next for cord blood expansion?
Though this FDA approval is for an expanded cord blood product intended for use in a very specific manner, this is a huge milestone for the field of transplant medicine and has the potential to help make cord blood a more routine choice for lifesaving medical treatments through HSCT.
Cord blood expansion has been a hot topic in research for over a decade4 and there are other companies working on similar expanded cord blood products5 that may one day have broader applications beyond use in specific HSCT applications.
The FDA’s approval of this new treatment option is a significant step in cord blood expansion technology and has been applauded by medical professionals in the cord blood community. It is expected to ultimately help advance the science of newborn stem cell applications and, in the future, potentially benefit Insception Lifebank families.
OMISIRGE® is a registered trademark of Gamida Cell Ltd.
1. OMISIRGE [package insert]. Gamida Cell. 2023. http://www.gamida-cell.com/wp-content/uploads/Omisirge-final-PI.pdf 2. Zhu X, Tang B, Sun Z. Umbilical cord blood transplantation: Still growing and improving. Stem Cells Transl Med. 2021;10 Suppl 2(Suppl 2):S62-S74. doi:10.1002/sctm.20-0495. 3. Ballen K. Update on umbilical cord blood transplantation. F1000Res. 2017;6:1556. Published 2017 Aug 24. doi:10.12688/f1000research.11952.1 4. 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. 5. Cohen S, et al. Hematopoietic stem cell transplantation using single UM171-expanded cord blood: a single-arm, phase 1-2 safety and feasibility study. Lancet Haematol. 2020 Feb;7(2):e134-e145. doi: 10.1016/S2352-3026(19)30202-9. Epub 2019 Nov 6. PMID: 31704264.