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NCT04388761 Clinical Trial

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)

Ischemia Reperfusion Injury Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04388761
Other study ID # 20-000264
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date September 2020
Est. completion date February 2024

Study information
Verified date October 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tambi Jarmi

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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