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 Overview
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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.

Official Title
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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)

Conditions
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Ischemia Reperfusion Injury

Intervention / Treatment
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* Drug: Allogeneic adipose derived mesenchymal stem cells


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events (SAEs) | 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 |