CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
NCT06569082 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-09-29
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.
Conditions
- Graft Failure
- Poor Graft Function
Interventions
- DEVICE
-
CD34+ Selected Donor Cell Boost
The CliniMACS CD34 Reagent System is used to separate CD34 cells from the remaining stem cell product, using a peripheral blood stem cell sample provided by the original donor. These CD34 cells are then infused into the recipient following selection with the intent to restore function of the blood forming cells.
- PROCEDURE
-
Blood Stem Cell Infusion
The selected CD34 cells separated by the CliniMACS CD34 Reagent System are infused into the recipient.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Jingmei Hsu · NYU Langone Health
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-31
- Primary Completion
- 2034-08-31
- Completion
- 2035-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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