NCT05456243

Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
BIOLOGICAL	Low dose adipose tissue derived mesenchymal stromal cells (A-MSC)	Single intra-arterial infusion of 1 x 10\^5 cells/kg
BIOLOGICAL	High dose adipose tissue derived mesenchymal stromal cells (A-MSC)	Single intra-arterial infusion of 5 x 10\^5 cells/kg infused over 5 minutes

Timeline

• Start date: 2023-01-30
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2022-07-13
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study