Phase I Study of Combined Deceased Donor Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment
Stanford University
Summary
This is a single arm phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation.
Description
Patients will undergo a standard of care deceased donor kidney transplant and thereafter the recipient will receive TLI (Total Lymphoid Irradiation)/single low dose Total Body Irradiation, ATG (Anti-Thymocyte Globulin) conditioning, followed by an infusion of whole bone marrow cells harvested from the same donor vertebral bodies. Patients will be receive standard of care doses of steroids, MMF and tacrolimus as part of their transplant immunosuppression. Subjects will be withdrawn from the immunosuppression if they have met the withdrawal criteria.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: RECIPIENT INCLUSION CRITERIA: 1. Patient is ≥ 18 years old, and \<65 years of age. 2. Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care. 3. Listed with the Organ Procurement and Transplantation Network (OPTN) for deceased donor transplantation. 4. A serotypic (Human Leucocyte Antigen) HLA match with the donor of a least 1 locus in A, B or DR. 5. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year post transplant. 6. Females have a negative serum…
Interventions
- BiologicalCombined Deceased Donor Kidney and Hematopoietic Cell Transplants
This combined kidney and hematopoietic cell transplants with a conditioning regimen with irradiation and ATG creates an environment of immune-tolerance. This promotes hematopoietic cell engraftment.
Locations (2)
- Stanford UniversityPalo Alto, California
- MSOBStanford, California