CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure

Inclusion Criteria7

• Recipient of allogeneic transplantation, adult ≥18 years, from any type of donor including matched related, matched unrelated, mismatched related or mismatched unrelated or haploidentical donor transplant.
• Documented evidence of graft dysfunction or failure (a-c):
• Primary graft Failure: Graft failure is defined as failure to achieve neutrophil engraftment by day +28 or lack of donor chimerism > 50% by day 45 not due to the underlying malignancy;
• Poor graft function is defined by at least 2 of the following 3 criteria: Hemoglobin < 8 g/dL, ANC < 0.5x109/L, and platelets < 20x109/L. The cytopenia must be unexplained (such as by disease relapse) and unresponsive to hematopoietic growth factors and must last at least 4 weeks;
• Secondary graft failure is defined as poor graft function associated with donor chimerism < 5% after initial engraftment
• Transplanted donor availability
• Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.