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Expanded Access Protocol Using CD3+/CD19+ Depleted PBSC

NCT02356653 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-20

No results posted yet for this study

Summary

The goal of this protocol is to expand access for patients who lack a fully HLA (Human leukocyte antigen) matched sibling donor and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-threatening disease for which HSCT is indicated. These patients are not eligible for other Children's Hospital of Philadelphia IRB approved protocols that utilize CliniMACs technology for T depletion.

Conditions

  • Leukemia
  • Inborn Errors of Metabolism
  • Bone Marrow Failure Syndromes
  • Immunodeficiencies
  • Immunodysregulation Polyendocrinopathy Enteropathy X-linked Syndrome

Interventions

BIOLOGICAL

Transplant of stem cells with CD3+/CD19+ depletion (CliniMACs)

Processing of stem cells using the CliniMACs device to selectively deplete specific T cells to decrease risk of graft versus host disease when using donor stem cells which are not fully matched.

Sponsors & Collaborators

Principal Investigators

  • Timothy Olson, MD, PhD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2027-01-31
Completion
2030-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02356653 on ClinicalTrials.gov