Status:

WITHDRAWN

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)

Lead Sponsor:

Tambi Jarmi

Conditions:

Ischemia Reperfusion Injury

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2024

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04388761

Start Date

September 1 2020

End Date

February 1 2024

Last Update

October 18 2023

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