Ischemia Reperfusion Injury
Conditions
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.
Interventions
DRUGAllogeneic adipose derived mesenchymal stem cells
Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft
Sponsors
Tambi Jarmi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events (SAEs) | 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). |
Outcome results
None listed