NCT06569082

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

CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-31
• Primary completion: 2034-08-01
• Completion: 2035-08-01
• First posted: 2024-08-23
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study