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
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Time Frame
Start Date: 2023-01-30
Estimated Completion Date: 2026-04
Participants
Target number of participants: 12
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov