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

This study is testing a treatment called CD34+ Selected Donor Cell Boost for people who have had a stem cell transplant and are experiencing graft failure (when the transplanted cells don't work) or poor graft function (when they don't work well). This treatment uses a special system called the CliniMACS CD34 Reagent System to separate specific stem cells (CD34+ cells) from the original donor's blood. These selected cells are then given to you to help your blood counts recover. The study aims to see how many participants have their white blood cells (Absolute Neutrophil Cells or ANC) and platelets recover by 100 days after the procedure. This study is for adults aged 18 and older who have received any type of stem cell transplant and have documented graft dysfunction or failure. The study is currently unclear about its recruitment status and plans to enroll 21 participants.

Study design
This is a single-center pilot study, meaning it's an early study at one location, and all participants will receive the same treatment (single-arm). It plans to include 21 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at 100 days after the procedure, focusing on blood cell recovery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06569082

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

Recruiting
NAAges 18+InterventionalTreatment
NYU Langone Health
~21 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:CD34+ Selected Donor Cell BoostBlood Stem Cell Infusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment
Measured over Day 100 Post-Procedure
+1 more outcome measured

Conditions

Graft Failure
Poor Graft Function

Explore related trials

Graft FailurePoor Graft Function

NCT06569082

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NYU Langone Health

    New York, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jingmei Hsu · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Kiselle Mangalindan
[email protected]
646-501-2973
Email the study team

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Eligibility criteria

Inclusion

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):
Transplanted donor availability
Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.

Exclusion

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

What this trial measures

  • Number of Participants with Absolute Neutrophil Cell (ANC) EngraftmentDay 100 Post-Procedure

    ANC engraftment is defined as ANC of ≥ 0.5 × 10\^9/L for three consecutive laboratory values obtained on different days.

  • Number of Participants with Platelet EngraftmentDay 100 Post-Procedure

    Platelet engraftment is defined as no platelet transfusions administered for seven consecutive days.