The FDA labels cord blood as a drug when used for stem cell transplantation in patients not related to the donor. What about expiration dates for this drug?
Cord blood units are placed in cryopreservation storage after the birth of a child to harness the promise of stem cells. Sometimes the intent is for the unit to become a life-saving intervention for an unrelated patient. Occasionally, the unit becomes a blessing for a close relative. Other times, it is an insurance plan for the newborn. All three scenarios pose the prospect of the cord blood unit being retrieved from storage after several years. This begs the question, what is the expiration date on cryopreserved cord blood?
The Vaccines, Blood, and Biologics branch of the FDA regulates cord blood. Use in an unrelated donor meets the definition of “drug”. As such, it must be licensed under a biologics license application (BLA) or an investigational new drug application (IND) before use. Personal use or use in close relatives does not require such approval. However, private banks must still comply with other FDA requirements, including being registered and listed, testing for infectious diseases, meeting FDA’s reporting and labeling requirements, and being in compliance with current good tissue practice (cGTP) regulations.
Even with FDA oversight, transplant physicians are concerned with the integrity of cord blood units retrieved from long term storage. There is research data demonstrating that hematopoietic progenitor cell recoveries from units stored 10-15 years is comparable to that from short-term freeze ranging from 2 to 8 weeks. Studies even have demonstrated comparable transplantation outcomes in mice using 15 year frozen cord blood stem cells and fresh units. However, preclinical data is promising albeit not a replacement for clinical evaluation.
The first clinical report evaluating the duration of storage on the outcome from single cord blood transplants in patients was recently highlighted. Parameters to gauge potency of the cord blood unit included measuring how soon it took for transplanted cells to affect neutrophil and platelet recovery in the patient. No significant differences were observed between using old cord units (up to 12 years) vs. new. Factors that did however affect time to neutrophil and platelet recovery included the patient’s age, weight, total nucleated cell count (TNCC), and CD34+ cell count. Larger studies are necessary to confirm the findings and for further data that can be used in drafting guidelines.
HemaCare supplies cord blood stem cells for research use to enable preclinical studies for translation to the clinical setting.
1: Parmar S, de Lima M, Worth L, Petropoulos D, Lee D, Cooper L, Kongtim P, Alousi A, Hosing C, Popat U, Kebriaei P, McNiece I, Shpall E, Rondon G, Champlin R. Is there an expiration date for a cord blood unit in storage? Bone Marrow Transplant. 2014 May 5. PMID: 24797184.