Clinical translation of perinatal stem cell therapies: a decade-long analysis of umbilical cord blood and umbilical cord tissue-derived mesenchymal stromal cell research, 2015-2025.

Authors

Upamannyue Roy Choudhury, Shaon Ray Chaudhuri, Raviraj Ramesh Kadam

Published in

Cell and tissue banking. Volume 27. Issue 4. Oct 30, 2026. Epub Oct 30, 2026.

Abstract

Umbilical cord blood (UCB) stem cells and mesenchymal stromal cells from cord tissue (UC-MSCs) have served as the foundation for regenerative and cellular therapy research for over 30 years and are also the scientific basis for the global private cord blood banking industry; however, it is uncertain whether clinical evidence has kept pace with the therapeutic claims made. This structured narrative review characterizes how clinical translation for both UCB and UC-MSC evolved between 2015 and 2025, using clinical trial registers, regulatory decisions and systematic reviews/meta-analyses, and asks whether this pathway is consistent with value propositions used in private cord blood banking marketing. Although plateauing following the results of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 1101 trial, UCB transplantation remains clinically relevant through ex-vivo expansion (Omidubicel/Omisirge, approved by the U.S. Food and Drug Administration [FDA] in 2023 and 2025) and other cord-blood-derived products such as chimeric antigen receptor natural killer (CAR-NK) cells. Infusion of autologous UCB for neurological indications shows an acceptable safety profile but variable efficacy; a phase II autism study found no benefit on its primary endpoint. UC-MSC research has expanded significantly, with meta-analytic support now available for knee osteoarthritis and, from mixed-source MSC studies, autoimmune disease, and early-phase evidence for liver failure and diabetic nephropathy. The center of gravity of perinatal stem cell innovation has shifted from autologous transplantation toward manufactured, largely allogeneic therapeutics, which may alter the underlying assumptions regarding informed consent that guide private CBB practice, a claim this review does not itself test empirically.

PMID:
42961672
Bibliographic data and abstract were imported from PubMed on 31 Oct 2026.

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