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Challenges in recruiting participants.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra parenchymal injection | Experimental | 5 subjects will receive AMSCs via direct injection into the kidney parenchyma only |
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| Intra-arterial infusion | Experimental | 5 subjects will receive AMSCs via intra-arterial infusion only |
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| Intra parenchymal injection & Intra-arterial infusion | Experimental | 5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic adipose derived mesenchymal stem cells | Drug | Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft |
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| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tambi Jarmi, MD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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