Using CD34+ Selected Stem Cells to Treat Graft Failure
CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation
This study is testing if using special stem cells can help people who have had a stem cell transplant and are experiencing problems with their graft.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06569082 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have undergone allogeneic transplantation and show evidence of graft dysfunction or failure.
Not a fit: Patients who do not have documented graft dysfunction or failure or those who are not eligible for allogeneic transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve engraftment rates and recovery for patients with graft dysfunction or failure.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving graft function using selected stem cells.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.