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RECRUITING
NCT06047886
PHASE1

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Official title: Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS

Key Details

Gender

All

Age Range

4 Weeks - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-04-22

Completion Date

2029-12

Last Updated

2025-04-24

Healthy Volunteers

No

Interventions

DRUG

Infusion of CD34 selected hematopoietic stem cells

CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States