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"Untreated" in the context of the PUMA clinical trial (NCT01627314) refers to unmanipulated umbilical cord blood (UCB). This biologic therapy consists of standard, unmodified hematopoietic stem and progenitor cells collected from the umbilical cord and placenta. In the Phase 2 PUMA trial sponsored by Fate Therapeutics, unmanipulated cord blood served as the control arm comparator against ProHema-CB (an ex vivo modulated cord blood product). The therapy is used in double-unit umbilical cord blood transplantation (dUCBT) to provide hematopoietic reconstitution and immune recovery in patients with various hematologic malignancies, such as leukemia and lymphoma, following myeloablative or reduced-intensity conditioning regimens. The trial was ultimately terminated due to a business decision by the sponsor.
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