79
Participants
Start Date
March 14, 2017
Primary Completion Date
July 17, 2020
Study Completion Date
March 27, 2021
Umbilical Cord Blood
Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
Placebo
The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
Wake Forest Baptist Medical Center, Winston-Salem
Duke University Medical Center, Durham
Emory University School of Medicine, Atlanta
University of Florida Health Shands Hospital, Gainesville
Houston Methodist, Houston
University of Colorado Anschutz Medical Campus, Aurora
The Marcus Foundation
OTHER
Emory University
OTHER
M.D. Anderson Cancer Center
OTHER
Joanne Kurtzberg, MD
OTHER