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

Recruiting now · Not applicable

Conditions studied: Graft Failure, Poor Graft Function

In brief

The proposed trial is a single arm, non-randomized, single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant (HSCT) requiring treatment of graft dysfunction or failure.

Key facts

Study ID

NCT06569082

Run by

NYU Langone Health

People needed

21

Starts

2024-10-31

Expected to finish

2035-08-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• NYU Langone Health — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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