Actively Recruiting
Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR)
Led by Mayo Clinic · Updated on 2025-10-14
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental treatment involving the infusion of allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC) directly into the renal artery to determine its safety and potential to reduce inflammation and treat rejection in adult kidney transplant recipients. The study focuses on those with subclinical rejection confirmed by biopsy, including antibody-mediated and cellular rejection. This phase 1 study aims to better understand this novel therapy's impact on kidney transplant rejection. Participants are divided into two groups receiving different doses of the treatment: one group receives a low dose (1 x 10^5 cells/kg) and the other a high dose (5 x 10^5 cells/kg) of allo-A-MSC via a single intra-arterial infusion, with the high dose infused over five minutes. Both groups consist of adults with stable renal function and biopsy-proven rejection within three months prior to enrollment. Throughout the study, participants will be closely monitored for adverse events over one year and assessed for worsening kidney allograft rejection 28 days after infusion. Researchers will evaluate kidney function, immune response, and safety through clinical and laboratory assessments. The study duration includes follow-up visits to ensure participant safety and to gather data on the treatment's effects in kidney transplant rejection management.
CONDITIONS
Brief Title
Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Received a renal transplant (first or repeat)
- Most recent protocol biopsy within 3 months of consent shows antibody-mediated or cellular rejection
- Stable kidney function with serum creatinine no more than 15% higher than before biopsy
- Estimated eGFR above 30 ml/min by MDRD
- Histologic evidence of antibody-mediated rejection or cellular rejection including borderline rejection
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
- Hemoglobin 8 g/dL or less
- Potassium 5.5 mEq/dL or more
- Alanine aminotransferase 60 U/L or more
- Hemoglobin A1C 7% or more
- International Normalized Ratio 2.0 or more
- Platelet count less than 50 x 10^9/L (unless transfused)
- Temperature 38°C (100.4°F) or higher
- Respiratory rate 20/min or higher
- Oxygen saturation 90% or less
- Systolic blood pressure above 160 mmHg or below 100 mmHg
- Pulse less than 45/min or greater than 140/min
- Severe vascular diseases including NYHA Class 3-4 heart failure, uncontrolled arrhythmias, recent stroke, or peripheral arterial disease with prior interventions
- Acute illness within 30 days
- Allergy or intolerance to iodinated contrast agents
- Women or male partners unwilling to use effective contraception during and 12 months after treatment
- History or current alcohol abuse, illicit drug use or dependence
- Active COVID-19 or positive SARS-CoV-2 test
- History of malignancy within 5 years (except certain treated skin or cervical cancers)
- HIV infection
- Epstein Barr Virus or Cytomegalovirus seronegative status
- Active post-transplant opportunistic infections
- Active Hepatitis B or C infection
- Kidney transplant from Hepatitis C positive donor planning anti-viral treatment
- Chronic conditions preventing safe interruption of anticoagulation therapy
- Positive pregnancy test
- Participation in other investigational drug studies within the past year
- Any other condition or factor increasing risk or preventing safe participation
- Presence of other kidney diseases not related to rejection as per Banff criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment day with follow-up for 28 days
Participants receive a single intra-arterial infusion of adipose tissue-derived mesenchymal stromal cells (A-MSC) at either a low or high dose to treat kidney transplant rejection.
1 infusion visit and several follow-up visits over 28 days
Duration - Up to 1 year
Participants are monitored for adverse events and kidney function for up to 1 year after treatment.
Periodic visits for safety monitoring over 1 year
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
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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