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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischemia Reperfusion Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intra parenchymal injection

5 subjects will receive AMSCs via direct injection into the kidney parenchyma only

Group Type EXPERIMENTAL

Allogeneic adipose derived mesenchymal stem cells

Intervention Type DRUG

Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft

Intra-arterial infusion

5 subjects will receive AMSCs via intra-arterial infusion only

Group Type EXPERIMENTAL

Allogeneic adipose derived mesenchymal stem cells

Intervention Type DRUG

Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft

Intra parenchymal injection & Intra-arterial infusion

5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion

Group Type EXPERIMENTAL

Allogeneic adipose derived mesenchymal stem cells

Intervention Type DRUG

Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft

Interventions

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Allogeneic adipose derived mesenchymal stem cells

Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No