Back to resultsFeasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)
Primary Purpose
Ischemia Reperfusion Injury
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Allogeneic adipose derived mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Ischemia Reperfusion Injury
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Intra parenchymal injection
Intra-arterial infusion
Intra parenchymal injection & Intra-arterial infusion
Arm Description
5 subjects will receive AMSCs via direct injection into the kidney parenchyma only
5 subjects will receive AMSCs via intra-arterial infusion only
5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04388761
Brief 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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Challenges in recruiting participants.
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tambi Jarmi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Reperfusion Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intra parenchymal injection
Arm Type
Experimental
Arm Description
5 subjects will receive AMSCs via direct injection into the kidney parenchyma only
Arm Title
Intra-arterial infusion
Arm Type
Experimental
Arm Description
5 subjects will receive AMSCs via intra-arterial infusion only
Arm Title
Intra parenchymal injection & Intra-arterial infusion
Arm Type
Experimental
Arm Description
5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion
Intervention Type
Drug
Intervention Name(s)
Allogeneic adipose derived mesenchymal stem cells
Intervention Description
Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft
Primary Outcome Measure Information:
Title
Serious Adverse Events (SAEs)
Description
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).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tambi Jarmi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this 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)
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