Status:
COMPLETED
Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
Lead Sponsor:
Medeor Therapeutics, Inc.
Collaborating Sponsors:
California Institute for Regenerative Medicine (CIRM)
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antig...
Detailed Description
Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial si...
Eligibility Criteria
Inclusion
- Recipient
- Planned recipient of a first kidney allograft from an HLA-matched, living related donor
- Age ≥18 and ≤70 years
- Single solid organ recipient (kidney only)
- ABO matched with donor
- Recipient
Exclusion
- Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
- Baseline positive donor-specific anti-HLA antibody testing
- Is taking immunosuppressive therapy
- Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)
- Donor Inclusion Criteria:
- HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling or half sibling) relative of the prospective recipient participant
- Age ≥18 and ≤70 years
- Prepared to be a living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells
- Donor
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03363945
Start Date
March 15 2018
End Date
April 11 2024
Last Update
June 7 2024
Active Locations (19)
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1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
2
USC
Los Angeles, California, United States, 90033
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
University of Colorado Denver
Aurora, Colorado, United States, 80045