Expanded Access Protocol Using CD3+/CD19+ Depleted PBSC
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bone Marrow Failure Syndromes
- Immunodeficiencies
- Immunodysregulation Polyendocrinopathy Enteropathy X-linked Syndrome
- Inborn Errors of Metabolism
- Leukemia
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 30 years
- Gender
- Both males and females
Description
Only 25-30% of patients who may benefit from HSCT have a matched related donor. There is a higher rate of complications using cells from an unrelated or partially matched related donor. T cells within the donor cells may cause a complication called graft vs. host disease (GVHD). The goal of this stu...
Only 25-30% of patients who may benefit from HSCT have a matched related donor. There is a higher rate of complications using cells from an unrelated or partially matched related donor. T cells within the donor cells may cause a complication called graft vs. host disease (GVHD). The goal of this study is to use the CliniMACs device to remove the T cells that cause GVHD, called T cell depletion.
Tracking Information
- NCT #
- NCT02356653
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nancy J Bunin, MD Children's Hospital of Philadelphia
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