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

NCT ID: NCT06569082

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2035-08-31

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.

Detailed Description

The primary objective of the study is to estimate the incidence of engraftment with sustained recovery of blood counts, including, absolute neutrophil cell (ANC) and platelet engraftment.

• ANC engraftment is defined as ANC of ≥ 0.5 × 10^9/L for three consecutive laboratory values obtained on different days. Date of ANC recovery is the date of the first of three consecutive laboratory values where the ANC is ≥ 0.5 × 10^9/L.
• Platelet engraftment should reflect no platelet transfusions administered for seven consecutive days. Report the date of the first of three consecutive laboratory values ≥ 20 × 10^9/L obtained on different days.

The secondary objective of the study is to estimate the incidence of Graft-versus-host disease (GvHD) and side effects that can be attributed to the CliniMACS CD34 Selected Cellular Product.

Conditions

Graft Failure; Poor Graft Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CD34+ Selected Donor Cell Boost

Intervention Type: 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

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

Blood Stem Cell Infusion

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

Intervention Type: PROCEDURE

Other Intervention Names

CliniMACS CD34 Reagent System

Eligibility Criteria

Inclusion Criteria

• 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):

1. 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;

2. 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;

3. 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jingmei Hsu

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kiselle Mangalindan

Role: CONTACT

KiselleAnne.Mangalindan@nyulangone.org

646-501-2973

Kelsey Stocker

Role: CONTACT

Kelsey.Stocker@nyulangone.org

646-501-4848

Other Identifiers

23-00885

Identifier Type: -

Identifier Source: org_study_id