Using CD34+ Selected Stem Cells to Treat Graft Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the effectiveness of CD34+ selected stem cells in patients experiencing graft dysfunction or failure after allogeneic hematopoietic stem cell transplantation. It is a single-arm, non-randomized study that focuses on measuring the incidence of engraftment and recovery of blood counts, specifically absolute neutrophil count and platelet levels. The study will also assess the occurrence of graft-versus-host disease and any side effects related to the treatment. Participants will receive a blood stem cell infusion using the CliniMACS CD34 Reagent System.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jingmei Hsu — NYU Langone Health
• Study coordinator: Kiselle Mangalindan
• Email: KiselleAnne.Mangalindan@nyulangone.org
• Phone: 646-501-2973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.