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SCID Bu/Flu/ATG Study With T Cell Depletion

NCT02127892 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-09-18

Study results available
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Summary

This is a pilot clinical trial of hematopoietic stem cell transplantation for patients with a diagnosis of Severe Combined Immune Deficiency (SCID) who do not have an HLA-matched sibling donor. The stem cells will be derived from a 1) matched unrelated donor (MUD), 2) unrelated cord blood donor, or 3) a haplo-identical (parental) donor (in descending order of preference).Patients will receive a novel conditioning regimen with Busulfan, Fludarabine and Anti-thymocyte globulin (ATG) followed by an unrelated donor hematopoietic stem cell transplant (HSCT) with T-cell depletion using the CliniMACS device.

Conditions

  • Severe Combined Immunodeficiency

Interventions

BIOLOGICAL

unrelated BM with T cell depletion

Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted).

BIOLOGICAL

unrelated cord blood

Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP.

BIOLOGICAL

haplo BM with T cell depletion

haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation.

DEVICE

unrelated PBSC with T cell depletion

peripheral blood stem cell will be processed for CD34+ cell isolation.

Sponsors & Collaborators

  • Neena Kapoor, M.D.

    lead OTHER

Principal Investigators

  • Neena Kapoor, M.D. · Children's Hospital Los Angeles, University of Southern California

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-02
Primary Completion
2016-08-01
Completion
2016-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02127892 on ClinicalTrials.gov