Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)

October 16, 2023 updated by: Tambi Jarmi
The purpose of this research is to test an investigational drug called Adipose Mesenchymal Stem Cells (aMSCs) for the treatment of ischemia re-perfusion injury (IRI) in patients that have had a kidney transplant.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female kidney transplant candidates age 18 and above.
  • Patient is receiving kidney allograft from deceased donor with KDPI>85%.
  • Ability of subject to give appropriate consent.
  • Females of childbearing potential with agreement to use birth control for six months post-transplant.
  • Approved by the Mayo Clinic Transplant Selection Committee.
  • Signed Authorization for Donation of Anatomical Gifts on file.

Exclusion Criteria:

  • Positive pregnancy test at the time of the kidney offer is called for the potential recipient.
  • Kidney transplant potential recipients with active malignancy (except none melanoma skin malignancies).
  • Patients with previous history of solid organ transplant (Heart, Lung, Intestine, Kidney and/or Pancreas).
  • Patients with previous history of bone marrow transplant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra parenchymal injection
5 subjects will receive AMSCs via direct injection into the kidney parenchyma only
Drug: Allogeneic adipose derived mesenchymal stem cells
Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft
Experimental: Intra-arterial infusion
5 subjects will receive AMSCs via intra-arterial infusion only
Drug: Allogeneic adipose derived mesenchymal stem cells
Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft
Experimental: Intra parenchymal injection & Intra-arterial infusion
5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion
Drug: Allogeneic adipose derived mesenchymal stem cells
Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events (SAEs)
Time Frame: 1 year
Number of serious adverse events reported. SAEs will include delayed graft function (30 days post-transplant), difficult to control bleeding (intraoperative), sub-scapular kidney hematoma or arteriovenous fistula formation (24 hours postop), and development of stroke, myocardial infarction, or pulmonary embolism (1 year post-transplant).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tambi Jarmi

Investigators

  • Principal Investigator: Tambi Jarmi, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2020

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-000264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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