Expanded Access Protocol Using CD3+/CD19+ Depleted PBSC

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT02356653
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Transplant of stem cells with CD3+/CD19+ depletion (CliniMACs) — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2013
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Expanded access to CliniMACs device for T cell depletion
    access for patients who lack a fully HLA matched sibling, and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-open protocols that utilize CliniMACs technology for T depletion. Subjects will undergo transplant of stem cells with CD3+/CD19+ depletion.

Primary Outcome Measure

Overall Survival [ Time Frame: 1 year post transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Megan Atkinson
[email protected]
215-590-2820
Patricia Hankins, BSN, RN, CCRC
[email protected]
215-590-5168
Timothy Olson, MD, PhD (PRINCIPAL_INVESTIGATOR)
Stephan A Grupp, MD, PhD (SUB_INVESTIGATOR)

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