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)

Phase 1

Withdrawn

• Conditions: Ischemia Reperfusion Injury
• Interventions: Drug: Allogeneic adipose derived mesenchymal stem cells

• Registration Number: NCT04388761
• Lead Sponsor: Tambi Jarmi

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 transplant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-14
• Study Start: 2020-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra parenchymal injection	Allogeneic adipose derived mesenchymal stem cells	5 subjects will receive AMSCs via direct injection into the kidney parenchyma only
Intra-arterial infusion	Allogeneic adipose derived mesenchymal stem cells	5 subjects will receive AMSCs via intra-arterial infusion only
Intra parenchymal injection & Intra-arterial infusion	Allogeneic adipose derived mesenchymal stem cells	5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events (SAEs)	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).