Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04388761
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Tambi Jarmi, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Ischemia Reperfusion Injury Drug: Allogeneic adipose derived mesenchymal stem cells Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2024

Arm Intervention/treatment
Experimental: Intra parenchymal injection
5 subjects will receive AMSCs via direct injection into the kidney parenchyma only
Drug: Allogeneic adipose derived mesenchymal stem cells
Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft

Experimental: Intra-arterial infusion
5 subjects will receive AMSCs via intra-arterial infusion only
Drug: Allogeneic adipose derived mesenchymal stem cells
Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft

Experimental: Intra parenchymal injection & Intra-arterial infusion
5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion
Drug: Allogeneic adipose derived mesenchymal stem cells
Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft




Primary Outcome Measures :
  1. Serious Adverse Events (SAEs) [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388761


Locations
Layout table for location information
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Elizabeth M. Starck    904-953-7971    Starck.Elizabeth@mayo.edu   
Contact: Mauricia Buchanan, R.N.    904-953-9455    Buchanan.Mauricia@mayo.edu   
Sponsors and Collaborators
Tambi Jarmi
Investigators
Layout table for investigator information
Principal Investigator: Tambi Jarmi, MD Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Tambi Jarmi, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04388761    
Other Study ID Numbers: 20-000264
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Reperfusion Injury
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications