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Expanded Access Protocol Using Alpha/Beta T and CD19+ Depleted PBSC

NCT03145545 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-05-22

No results posted yet for this study

Summary

The primary objective 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 Institutional Review Board (IRB) approved protocols that utilize CliniMACs technology for T depletion.

Conditions

  • Leukemia
  • Bone Marrow Failure Syndrome
  • Immunodeficiencies

Interventions

DEVICE

Apha/beta T and CD19+ cell depletion using CliniMACS device

Stem cells will be processed using the CliniMACS device for alpha/beta and CD19+ T cell depletion. Processing of cells using the CliniMACS will occur in accordance with the Investigator Brochure and Technical Manual following the laboratory standard operating procedures (SOPs) and using aseptic technique.

Sponsors & Collaborators

Principal Investigators

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

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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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 NCT03145545 on ClinicalTrials.gov