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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06569082 on ClinicalTrials.gov