Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR)
Mayo Clinic
Summary
This research study is being done to learn if an experimental treatment of infusing allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC ) directly into the renal artery is safe and can help reduce inflammation in the transplanted kidney and treat rejection.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Able to understand and provide informed consent. * Have received a renal transplant (first or repeat), and the most recent protocol biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection. Clinical Inclusion Criteria: * Stable renal function: * Serum creatinine at the time of surveillance biopsy cannot be \> 15% greater than the serum creatine prior to the biopsy (must be within 3 months of the biopsy); * Estimated eGFR \> 30 ml/min by MDRD. Histologic Criteria for Eligibility: * ABMR: microvascular inflammation scores for glomerulitis (g) and…
Interventions
- BiologicalLow dose adipose tissue derived mesenchymal stromal cells (A-MSC)
Single intra-arterial infusion of 1 x 10\^5 cells/kg
- BiologicalHigh dose adipose tissue derived mesenchymal stromal cells (A-MSC)
Single intra-arterial infusion of 5 x 10\^5 cells/kg infused over 5 minutes
Location
- Mayo ClinicRochester, Minnesota