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)
Overview
- Phase
- Phase 1
- Intervention
- Allogeneic adipose derived mesenchymal stem cells
- Conditions
- Ischemia Reperfusion Injury
- Sponsor
- Tambi Jarmi
- Primary Endpoint
- Serious Adverse Events (SAEs)
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Tambi Jarmi
Principal Investigator
Mayo Clinic
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.
Arms & Interventions
Intra parenchymal injection
5 subjects will receive AMSCs via direct injection into the kidney parenchyma only
Intervention: Allogeneic adipose derived mesenchymal stem cells
Intra-arterial infusion
5 subjects will receive AMSCs via intra-arterial infusion only
Intervention: Allogeneic adipose derived mesenchymal stem cells
Intra parenchymal injection & Intra-arterial infusion
5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion
Intervention: Allogeneic adipose derived mesenchymal stem cells
Outcomes
Primary Outcomes
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).