A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, UCB-derived, Stem and Progenitor Cells, vs. Unmanipulated UCB for Patients With Hematological Malignancies
This study compares two methods using umbilical cord blood as a source of stem cells for patients undergoing bone marrow transplantation. The first method uses standard cord blood units, where the unit of cord blood is given the usual way ("unmanipulated"). The second, new method uses a technique to expand (increase) the number of umbilical cord blood cells before they are given. The study will evaluate if the new method helps patients recover their blood cells faster than the usual method, if there is a difference in the risk for infections after the transplant, and if the new method affects survival.
Bone marrow transplant
Umbilical cord blood
Hematopoietic stem cell transplant
Patients ages 12-65 must qualify for a bone marrow transplant and have one of the following conditions: Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in first complete remission with unfavorable risk or in second remission, or with chronic myelogenous leukemia (CML), MDS, Lymphoma, or other type of leukemia.
Patients must have umbilical cord units identified that can meet the matching criteria of the study, and have adequate heart function tests, other blood tests showing adequate liver and kidney function, and not be pregnant or have an uncontrolled infection. Patients cannot have had a prior stem cell transplant.
12 - 65
Healthy Volunteers Needed
Duration of Participation
15 months after randomization. If participating in the optional part of the study, follow-up may extend to 5 years after day of transplant.
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Gamida Cell, Ltd.