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

Inclusion Criteria:

• Recipient of allogeneic transplantation, adult ≥18 years, from any type of donorincluding matched related, matched unrelated, mismatched related or mismatchedunrelated or haploidentical donor transplant.

• Documented evidence of graft dysfunction or failure (a-c):

1. Primary graft Failure: Graft failure is defined as failure to achieveneutrophil engraftment by day +28 or lack of donor chimerism > 50% by day 45not due to the underlying malignancy;

2. 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 cytopeniamust be unexplained (such as by disease relapse) and unresponsive tohematopoietic growth factors and must last at least 4 weeks;

3. Secondary graft failure is defined as poor graft function associated with donorchimerism < 5% after initial engraftment

• Transplanted donor availability

• Negative pregnancy test within seven (7) days of product infusion for women ofchildbearing potential.

Exclusion Criteria:

• Graft failure due to disease relapse or evidence of disease relapse or progression

• Donor unavailable or unable to collect peripheral HPC by apheresis

• Responsive to conventional measures (such as, hematopoietic growth factor)

• Allergic reaction to murine proteins or iron dextran

• Women of childbearing potential with positive serum HCG