Trials / Recruiting
RecruitingNCT06047886
UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy
Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- All
- Age
- 4 Weeks – 75 Years
- Healthy volunteers
- Not accepted
Summary
Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.
Detailed description
Patients eligible to be treated on this status are status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function (e.g. marrow cellularity reduced per age and/or dropping donor chimerism with cytopenias and/or platelets or red blood cells transfusion requirement).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Infusion of CD34 selected hematopoietic stem cells | CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion |
Timeline
- Start date
- 2025-04-22
- Primary completion
- 2029-10-01
- Completion
- 2029-12-01
- First posted
- 2023-09-21
- Last updated
- 2026-04-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06047886. Inclusion in this directory is not an endorsement.