Actively Recruiting
CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation
Led by NYU Langone Health · Updated on 2025-09-29
21
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of a CD34+ selected stem cell boost for adults who have experienced poor graft function or graft failure after an allogeneic hematopoietic stem cell transplant (HSCT). The study focuses on estimating the frequency of successful blood count recovery, including neutrophil and platelet engraftment, and monitoring for graft-versus-host disease (GvHD) and other side effects related to the CD34 selected cellular product. Participants will receive a single infusion of CD34 selected hematopoietic stem cells obtained from their original donor using the CliniMACS CD34 Reagent System. No extra GvHD prevention treatments will be given, though patients who develop GvHD will be managed according to standard care. Supportive care will be provided based on institutional standards and the treating physician's discretion. During the study, participants will undergo evaluations before the infusion and be monitored for blood count recovery, specifically neutrophil and platelet levels, at day 100 post-procedure. Researchers will also observe for acute and chronic GvHD occurrences up to one year. The trial includes safety monitoring and supportive care throughout. The entire participation period spans at least one year with follow-up assessments to measure outcomes and side effects.
CONDITIONS
Brief Title
CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult recipients (18 years or older) of allogeneic transplantation from any donor type
- Documented graft dysfunction or failure defined as primary graft failure, poor graft function with specific blood count criteria lasting at least 4 weeks, or secondary graft failure with low donor chimerism
- Availability of the original donor for peripheral blood stem cell collection
- Negative pregnancy test within 7 days of infusion for women of childbearing potential
You will not qualify if you...
- Graft failure due to disease relapse or evidence of disease progression
- Donor unavailable or unable to collect peripheral hematopoietic progenitor cells by apheresis
- Responsive to conventional measures such as hematopoietic growth factors
- Allergic reaction to murine proteins or iron dextran
- Women of childbearing potential with positive serum HCG
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment event
Participants receive a single infusion of CD34 selected hematopoietic stem cells from the original donor to restore blood-forming cell function.
1 infusion visit (in-person)
Duration - Up to 1 year post-procedure
Participants are monitored for engraftment success, graft-versus-host disease, and side effects following the infusion.
Visits at multiple time points including Day 100 and Day 365 post-procedure
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
K
Kiselle Mangalindan
K
Kelsey Stocker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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