This phase 3 trial is comparing the safety and effectiveness of NiCord stem cell treatment with stem cells taken from the umbilical cord. The main outcome to be measured is the time to neutrophil engraftment (white blood cells accepted by the body that start to grow and make new cells) following transplantation.
Successful bone marrow transplant needs a high number of donor stem cells to be accepted by the body. Cells taken from umbilical cord blood for transplantation tend to be in low numbers compared to bone marrow or other sources. NiCord is a type of cell product made from umbilical cord cells that have been expanded to increase cell numbers.
This study compares the safety and effectiveness of NiCord with standard treatment with stem cells taken from the umbilical cord in patients with leukemia. The main outcome will be measured as the number of white blood cells in the transplant accepted by the body.
Who are they looking for?
120 patients with acute lymphoblastic leukemia (ALL), acute myelogenous leukemia (AML), and chronic myelogenous leukemia (CML) will be included in the study. Patients should have a back-up stem cell source and genetically matched cord blood units.
Patients should not have had a previous stem cell transplant from a donor, other active cancer, infection, or brain disease. Pregnant or breastfeeding women will not be allowed to participate.
How will it work
There will be two groups of patients. One group will receive NiCord blood. The other group will receive untreated umbilical cord blood for comparison. The main outcome measured will be time for white blood cells in the transplant to be accepted by the body.