Actively Recruiting
Expanded Access Protocol Using CD3+/CD19+ Depleted PBSC
Led by Children's Hospital of Philadelphia · Updated on 2026-02-20
100
Participants Needed
1
Research Sites
839 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Expanded Access Protocol Using CD3+/CD19+ Depleted PBSC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients lacking a fully HLA matched sibling donor and candidates for allogeneic hematopoietic stem cell transplant (HSCT) not suitable for other current protocols using CliniMACs for CD3+/CD19+ depletion
- Patients with transplantable diseases including metabolic storage diseases correctable by HSCT, bone marrow failure syndromes, immunodeficiencies/immune dysregulation syndromes including HLH, hemoglobinopathies requiring HSCT, acute and chronic leukemias, lymphomas, myelodysplastic syndrome, and other non-malignant blood, metabolic, or immune disorders recommended for HSCT
- Signed informed consent
- Lansky or Karnofsky performance score of 60 or higher
- Adequate hematologic and organ function per institutional standards
- Infectious disease evaluation per institutional standards
- Negative pregnancy test for participants of childbearing potential
- Identified living donor meeting regulatory and institutional criteria, including unrelated donors matched 10/10, 9/10, or 8/10 with specific HLA matching requirements, and related donors meeting infectious disease screening and mobilization criteria
- Emergency cases with graft failure or severe marrow suppression may have some criteria waived
You will not qualify if you...
- Uncontrolled bacterial, viral, or fungal infections
- Availability of a suitable fully HLA matched sibling donor
- Donor unable to donate peripheral stem cells
- Pregnant participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Megan Atkinson
CONTACT
P
Patricia Hankins, BSN, RN, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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