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

NCT06569082 | Recruiting DMC FDA Device

• 1 other identifier: 23-00885
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment

  ANC engraftment is defined as ANC of ≥ 0.5 × 10\^9/L for three consecutive laboratory values obtained on different days.

  Day 100 Post-Procedure

• Number of Participants with Platelet Engraftment

  Platelet engraftment is defined as no platelet transfusions administered for seven consecutive days.

  Day 100 Post-Procedure

Secondary Outcomes (2)

• Number of Participants with Grade II-IV Acute GVHD

  Day 100 Post-Procedure

• Number of Participants with Moderate to Severe Chronic GVHD

  Day 365 Post-Procedure

Study Arms (1)

Individuals with Poor Graft Function or Failure Following Allogeneic HSCT

EXPERIMENTAL

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.

Device: CD34+ Selected Donor Cell Boost; Procedure: Blood Stem Cell Infusion

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.

Also known as: CliniMACS CD34 Reagent System

Individuals with Poor Graft Function or Failure Following Allogeneic HSCT

Blood Stem Cell Infusion PROCEDURE

The selected CD34 cells separated by the CliniMACS CD34 Reagent System are infused into the recipient.

Individuals with Poor Graft Function or Failure Following Allogeneic HSCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipient of allogeneic transplantation, adult ≥18 years, from any type of donor including matched related, matched unrelated, mismatched related or mismatched unrelated or haploidentical donor transplant.
• Documented evidence of graft dysfunction or failure (a-c):
• Primary graft Failure: Graft failure is defined as failure to achieve neutrophil engraftment by day +28 or lack of donor chimerism \> 50% by day 45 not due to the underlying malignancy;
• Poor graft function is defined by at least 2 of the following 3 criteria: Hemoglobin \< 8 g/dL, ANC \< 0.5x109/L, and platelets \< 20x109/L. The cytopenia must be unexplained (such as by disease relapse) and unresponsive to hematopoietic growth factors and must last at least 4 weeks;
• Secondary graft failure is defined as poor graft function associated with donor chimerism \< 5% after initial engraftment
• Transplanted donor availability
• Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.

You may not qualify if:

• Graft failure due to disease relapse or evidence of disease relapse or progression
• Donor unavailable or unable to collect peripheral HPC by apheresis
• Responsive to conventional measures (such as, hematopoietic growth factor)
• Allergic reaction to murine proteins or iron dextran
• Women of childbearing potential with positive serum HCG

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Jingmei Hsu

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiselle Mangalindan

CONTACT

646-501-2973; KiselleAnne.Mangalindan@nyulangone.org

Kelsey Stocker

CONTACT

646-501-4848; Kelsey.Stocker@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 23, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): August 1, 2034
• Study Completion (Estimated): August 1, 2035
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: No time limit.
• Access Criteria: Requests should be directed to Jingmei.hsu@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)