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)

NCT04388761 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 20-000264
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemia Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Intra parenchymal injection

EXPERIMENTAL

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

Drug: Allogeneic adipose derived mesenchymal stem cells

Intra-arterial infusion

EXPERIMENTAL

5 subjects will receive AMSCs via intra-arterial infusion only

Drug: Allogeneic adipose derived mesenchymal stem cells

Intra parenchymal injection & Intra-arterial infusion

EXPERIMENTAL

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

Drug: Allogeneic adipose derived mesenchymal stem cells

Interventions

Allogeneic adipose derived mesenchymal stem cells DRUG

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

Intra parenchymal injection; Intra parenchymal injection & Intra-arterial infusion; Intra-arterial infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tambi Jarmi: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tambi Jarmi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 14, 2020
• Study Start: September 1, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share