Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor… (NCT03606746) | Clinical Trial Compass
WithdrawnPhase 2
Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor Kidney Transplants
Stopped: Lack of funding
0Started 2024-12
Plain-language summary
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Recipient Inclusion Criteria:
* Past 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 compatibility with donor
Donor Inclusion Criteria:
* HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling, half sibling) relative of the prospective recipient participant
* Age ≥18 and ≤70 years
* Past living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells
Exclusion Criteria:
Recipient Exclusion Criteria:
* 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 Exclusion Criteria:
* History of autoimmune disorders
* History of type 1 or type 2 diabetes mellitus
* Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV
* History of infection with Zika virus
What they're measuring
1
Persistent Mixed Chimerism
Timeframe: At 6 months post initiation of anti-thymocyte globulin (ATG) conditioning therapy