CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06569082
Status
Recruiting
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Conditions

  • Graft Failure
  • Poor Graft Function

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD34+ Selected Donor Cell Boost — DEVICE
    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.
  • Blood Stem Cell Infusion — PROCEDURE
    The selected CD34 cells separated by the CliniMACS CD34 Reagent System are infused into the recipient.

Study Details

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.

Key Dates

Start date
Oct 31, 2024
Status verified
Sep 2025
Primary completion
Aug 31, 2034
Completion
Aug 31, 2035

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Individuals with Poor Graft Function or Failure Following Allogeneic HSCT
    The recipient will undergo evaluations, then undergo a single infusion of CD34 selected HSCT from the original donor. No additional GvHD prophylaxis will be administered. Patients who develop GvHD will receive the standard of care based on the discretion of the treating physician . Patients will receive supportive care per institutional standards and at the discretion of the treating physician.

Primary Outcome Measure

Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment [ Time Frame: Day 100 Post-Procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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