The controlled study will enroll around 45 suitable adult patients and randomize them into 2:1 ratio with either ProHema together with an unmanipulated cord blood unit or two unmanipulated cord blood units.
Fate Therapeutics president and chief executive officer Christian Weyer said allogeneic umbilical cord blood transplantation is a potential healing treatment for children and adults with hematologic malignancies.
"ProHema is being developed with the intent to improve outcomes in patients undergoing cord blood transplantation by facilitating both accelerated engraftment and durable reconstitution using a simple, point-of-care, ex vivo modulation process," Weyer added.
The study will assess the time required for neutrophil and platelet recovery, occurrence of serious infections and graft-versus-host disease, 100-day mortality and comparative dominance of ProHema in contributing to reconstitution over the unmanipulated cord
Company expects to report the results of the study in 2013.
The safety and tolerability of Cord blood-derived cell therapy ProHema containing pharmacologically-modulated hematopoietic stem cells was established in Phase 1b study.