Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05456243
Phase
PHASE1
Status
Recruiting
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Conditions

  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 30, 2023
Status verified
Oct 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose Group
    Adult kidney transplant recipients with subclinical rejection (biopsy-proven antibody-mediated and/or cellular rejection, including borderline rejection) will be administered one low dose of allogeneic A-MSC.
  • Experimental: High Dose Group
    Adult kidney transplant recipients with subclinical rejection (biopsy-proven antibody-mediated and/or cellular rejection, including borderline rejection) will be administered one high dose of allogeneic A-MSC.

Primary Outcome Measure

Worsening kidney allograft rejection [ Time Frame: 28 days after A-MSC infusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Timucin Taner
[email protected]
5072663117

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By research site
Mayo Clinic· Rochester, MN

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