High Dose Group for Kidney Transplantation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Rochester, MN
Kidney Transplantation
Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
Adverse Events
Day 28
Worsening kidney allograft rejection

Trial Safety

Trial Design

2 Treatment Groups

High Dose Group
1 of 2
Low Dose Group
1 of 2
Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: High Dose Group · No Placebo Group · Phase 1

High Dose Group
Biological
Experimental Group · 1 Intervention: High dose adipose tissue derived mesenchymal stromal cells (A-MSC) · Intervention Types: Biological
Low Dose Group
Biological
Experimental Group · 1 Intervention: Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Trial Background

Timucin Taner, Principal Investigator
Principal Investigator
Mayo Clinic
Closest Location: Mayo Clinic · Rochester, MN
Photo of jacksonville mayo clinic  1Photo of jacksonville mayo clinic  2Photo of jacksonville mayo clinic  3
1989First Recorded Clinical Trial
15 TrialsResearching Kidney Transplantation
2165 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You 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.
Creatinine at the time of surveillance biopsy cannot be > 15% greater than the serum creatinine prior to the biopsy (must be within 3 months of the biopsy).
You have eGFR > 30 ml/min.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.