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Recruiting Phase 1 NCT05456243

Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

Trial Parameters

Condition Kidney Transplant
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 12
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-01-30
Completion 2026-04
Interventions
Low dose adipose tissue derived mesenchymal stromal cells (A-MSC)High dose adipose tissue derived mesenchymal stromal cells (A-MSC)

Brief 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 Criteria

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 peritubular capillaritis (ptc) (g:1 or 2; ptc:1 or 2). * Cellular rejection: tubulitis (t) (t:1or 2); interstitial inflammation (i) (i:1 or 2); intimal arteritis (v) (v: 1 or 2). * Mixed ABMR and cellular rejection. Exclusion Criteria: * Nephrotic range proteinuria (≥ 3.5g/24h), detected more than once in the year preceding screening. * History of post-transplant intervention for obstructive uropathy *

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