Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT05456243

Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

Led by Mayo Clinic · Updated on 2025-10-14

12

Participants Needed

1

Research Sites

165 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and provide informed consent.
  • Have received a renal transplant (first or repeat), with the most recent biopsy within 3 months showing antibody-mediated or cellular rejection.
  • Stable kidney function with serum creatinine no more than 15% higher than before the biopsy and estimated eGFR over 30 ml/min.
  • Histologic evidence of rejection including antibody-mediated rejection with microvascular inflammation scores or cellular rejection with tubulitis, interstitial inflammation, or intimal arteritis.
  • Mixed antibody-mediated and cellular rejection cases are eligible.
Not Eligible

You will not qualify if you...

  • Nephrotic range proteinuria (3.5g/24h or more) detected more than once in the past year.
  • History of post-transplant intervention for obstructive uropathy.
  • Laboratory abnormalities including hemoglobin 8 g/dL or less, potassium 5.5 mEq/dL or higher, ALT 60 U/L or higher, HbA1c 7% or higher, INR 2.0 or higher, or platelet count below 50 x 10^9/L (unless platelet transfusion given).
  • Vital sign abnormalities such as fever (≥38°C), elevated respiratory rate (≥20/min), low oxygen saturation (≤90%), high or low blood pressure (systolic >160 or <100 mmHg), or abnormal pulse (<45 or >140/min).
  • Serious vascular diseases including NYHA Class 3-4 congestive heart failure, uncontrolled arrhythmias (except rate-controlled chronic atrial fibrillation), recent stroke within 90 days, or peripheral arterial disease with prior interventions.
  • Acute illness within 30 days before screening.
  • Allergy or intolerance to iodinated contrast agents.
  • Women or male partners of women of childbearing potential unwilling to use effective contraception during treatment and for 12 months after.
  • History or current alcohol abuse, illicit drug use, or dependence.
  • Active COVID-19 infection or positive SARS-CoV-2 test.
  • History of malignancy within 5 years, except adequately treated in-situ cervical carcinoma or skin cancer.
  • Positive tests for HIV 1 or 2.
  • Epstein Barr Virus and Cytomegalovirus seronegative status.
  • Active post-transplant opportunistic infections.
  • Active hepatitis B or C infection or related antibody positivity, except previously treated hepatitis C or certain hepatitis B antibody statuses.
  • Kidney transplant from hepatitis C positive donor planning antiviral treatment.
  • Chronic conditions preventing safe interruption of anticoagulation for biopsy based on high thrombotic risk scores.
  • Positive pregnancy test.
  • Participation in other investigational drug studies within the past year.
  • Any other condition increasing risk from infusion or preventing safe participation as judged by the investigator.
  • Unwillingness or inability to follow study procedures.
  • Presence of other kidney changes not caused by rejection or related disorders as per Banff criteria category 6.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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