Clinical Trial

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

Active, Not Recruiting Phase 1/2
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2013-10-17; most recent amendment 2025-08-11.
Status change: Recruiting → Active, Not Recruiting 2020-06-17
Trial Details
NCT Number NCT01966367
Lead Sponsor Diane George
Conditions Bone Marrow Failure Syndrome, Severe Aplastic Anemia, Severe Congenital Neutropenia, Amegakaryocytic Thrombocytopenia, Diamond-Blackfan Anemia, Schwachman Diamond Syndrome, Primary Immunodeficiency Syndromes, Acquired Immunodeficiency Syndromes +8 more
Enrollment 37 participants
Start Date 2013-03
Primary Completion 2030-02 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2025-08-14