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

Recruiting

CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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):

  1. 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;
  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 cytopenia must be unexplained (such as by disease relapse) and unresponsive to hematopoietic growth factors and must last at least 4 weeks;
  3. 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.

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

About the study

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.

What is being tested

Sponsor: NYU Langone Health · Participants: 21 · Started: Oct 31, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06569082

Locations in the U.S.

New YorkNYU Langone Health, New York

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.