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ACTIVE NOT RECRUITING
NCT01966367
PHASE1/PHASE2

CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation

Sponsor: Diane George

View on ClinicalTrials.gov

Summary

This study's goal is to determine the frequency and severity of acute graft versus host disease, to evaluate incidence of primary and secondary graft rejection, to assess event free survival and overall survival, to determine the time to neutrophil and platelet engraftment, to determine the time to immune reconstitution (including normalization of T, B and natural killer (NK) cell repertoire and Immunoglobulin G production), and to establish the incidence of infectious complications including bacterial, viral, fungal and atypical mycobacterial and other infections following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a non-malignant disease.

Official title: CD34+ Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplantation for Non-Malignant Disease

Key Details

Gender

All

Age Range

Any - 40 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2013-03

Completion Date

2030-02

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

CD34 Stem Cell Selection Therapy

The CliniMACS (PLUS) Reagent System (Miltenyi CliniMACS CD34+ Cell Selection Device) will be used to remove T-cells from the peripheral blood stem cell transplant in order to decrease the risk of acute and chronic graft versus host disease (GVHD).

Locations (1)

Morgan Stanley Children's Hospital, New York-Presbyterian, Columbia University

New York, New York, United States