NCT06569082 CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
| NCT ID | NCT06569082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Graft Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2024-10-31 |
| Primary Completion | 2034-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 21 participants in total. It began in 2024-10-31 with a primary completion date of 2034-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jingmei Hsu
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06569082 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Graft Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06569082 currently recruiting?
Yes, NCT06569082 is actively recruiting participants. Contact the research team at KiselleAnne.Mangalindan@nyulangone.org for enrollment information.
Where is the NCT06569082 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06569082 clinical trial?
NCT06569082 is sponsored by NYU Langone Health. The principal investigator is Jingmei Hsu at NYU Langone Health. The trial plans to enroll 21 participants.