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Mesenchymal Stromal Cells

A-MSC Therapy for Kidney Transplant Rejection

Phase 1
Recruiting
Led By Timucin Taner, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new treatment for kidney transplant patients. The treatment is an infusion of allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC) directly into the renal artery. The purpose of the trial is to see if the treatment is safe and can help reduce inflammation in the transplanted kidney and treat rejection.

Who is the study for?
This trial is for kidney transplant recipients who can consent, have had a recent biopsy showing rejection, stable renal function with eGFR > 30 ml/min, and specific inflammation or rejection signs in the biopsy. Excluded are those with severe heart conditions, vascular diseases, acute illnesses within 30 days, allergies to contrast agents, unwilling to use contraception for 12 months post-treatment, substance abuse issues, active COVID-19 or other infections like CMV or BK virus.Check my eligibility
What is being tested?
The study tests if infusing different doses of adipose-derived mesenchymal stromal cells (A-MSC) into the renal artery can safely reduce inflammation and treat kidney transplant rejection. Participants will receive either a low dose or high dose of A-MSC directly into their transplanted kidney's blood supply.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site such as pain or swelling; immune responses leading to fever or fatigue; possible impact on blood pressure and organ function due to inflammatory changes; risk of infection from immunomodulation caused by MSCs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Worsening kidney allograft rejection

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low Dose GroupExperimental Treatment1 Intervention
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.
Group II: High Dose GroupExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,238 Previous Clinical Trials
3,771,789 Total Patients Enrolled
Timucin Taner, MD, PhDPrincipal InvestigatorMayo Clinic

Media Library

Adipose-derived MSC (Mesenchymal Stromal Cells) Clinical Trial Eligibility Overview. Trial Name: NCT05456243 — Phase 1
Kidney Transplant Research Study Groups: High Dose Group, Low Dose Group
Kidney Transplant Clinical Trial 2023: Adipose-derived MSC Highlights & Side Effects. Trial Name: NCT05456243 — Phase 1
Adipose-derived MSC (Mesenchymal Stromal Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456243 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you accept individuals aged 35 and over for this trial?

"This clinical trial is open to applicants that are at least 18 years old, yet not beyond the age of 70."

Answered by AI

Is there a current opportunity to participate in the experiment?

"Affirmative. Data hosted on clinicaltrials.gov substantiates that this medical experiment, which was initially posted on November 1st 2022, is actively recruiting patients. 12 individuals need to be enlisted from a solitary medical centre."

Answered by AI

What criteria must be met in order to qualify for this experimentation?

"This medical trial is recruiting 12 participants with ages between 18 and 70, who have experienced renal transplantation. Additionally, candidates must have the ability to comprehend informed consent documents as well as some defined laboratory values such as serum creatinine levels and estimated eGFRs. Protocol biopsies must be collected within 3 months of enrolment for diagnosis of either ABMR or cellular rejection; microvascular inflammation scores for glomerulitis (g) and peritubular capillaritis (ptc), tubulitis (t) intensity score for interstitial inflammation (i); intimal arteritis score(v). Mixed cases"

Answered by AI

Has the FDA sanctioned Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) for public use?

"The safety of Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) is rated at a 1 due to the current Phase 1 trial, which lacks detailed data surrounding its efficacy and safety."

Answered by AI

What is the total number of participants in this research endeavor?

"Affirmative. According to the clinicaltrials.gov website, this trial is currently enrolling participants after being initially posted on November 1st 2022 and most recently updated on the 7th of that month. A dozen patients are desired from a single medical site for participation in this experiment."

Answered by AI
~6 spots leftby Aug 2025