Donor cell boost aims to rescue failed stem cell transplants

NCT ID NCT06569082

Disease control Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This study tests a procedure called a CD34+ selected donor cell boost for people whose stem cell transplant has not worked well (graft failure or poor function). The donor's blood stem cells are separated using a special system and then infused back into the patient to help restore normal blood cell production. The trial will enroll 21 adults and measure whether blood cell counts improve without needing transfusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: CD34+ selected donor cells (CliniMACS CD34 Reagent System)
What this could lead to: If successful, this could offer a way to restore blood cell production in patients whose stem cell transplant has failed, reducing the need for additional transfusions.
What could go wrong: This is a very small, early pilot study with only 21 participants, so results may not apply to everyone. There are risks of graft-versus-host disease (GVHD) and the procedure may not work for all types of graft failure.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Aug 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graft failure Poor graft function

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

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Donor cell boost aims to rescue failed stem cell transplants

What the study statuses mean