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

NCT01966367 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-08-14

No results posted yet for this study

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.

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
  • Histiocytic Syndrome
  • Familial Hemophagocytic Lymphocytosis
  • Lymphohistiocytosis
  • Macrophage Activation Syndrome
  • Langerhans Cell Histiocytosis (LCH)
  • Hemoglobinopathies
  • Sickle Cell Disease
  • Sickle Cell-beta-thalassemia

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).

Sponsors & Collaborators

  • Diane George

    lead OTHER

Principal Investigators

  • Diane George, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2030-02-28
Completion
2030-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01966367 on ClinicalTrials.gov