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Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose Derived Mesenchymal Stem Cells | Experimental | Subjects diagnosed with End Stage Renal Disease (ESRD) and are currently on hemodialysis therapy with planned creation of a new upper extremity arteriovenous fistula will receive Adipose Derived Mesenchymal Stem Cells treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose Derived Mesenchymal Stem Cells | Drug | The dose will be specifically tailored to each subject's vascular anatomy determined by the surgeon through ultrasound measurements. Approximately 3-5 million cells in 5ml Ringer Lactate (RL) Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Evaluate the safety of AMSC administration by assessing the number of participants to experience an adverse event as defined by inflammation, infection (local or systemic), aneurysm formation, clinically significant increase or decrease in blood flow or thrombosis formation as evaluated through physical exam and ultrasound. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reagan Dukes | Contact | (904) 953-2077 | Dukes.Reagan@mayo.edu | |
| Mauricia Buchanan | Contact | (904) 953-2077 | buchanan.mauricia@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Houssam Farres, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |