AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: Adipose Derived Mesenchymal Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient between 18 and 85 years old Patient currently planned for creation of an upper extremity AV fistula with suitable anatomy Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures Life expectancy of at least 24 months If female, must be post-menopausal or not able to have children. Post-menopausal/non-child bearing status must be clearly documented in the medical record. If documentation of post-menopausal/non-child bearing status is not available then a pregnancy test must be performed. Exclusion Criteria: Malignancy or treatment for malignancy within the previous 6 months Immunodeficiency including AIDS / HIV or Active autoimmune disease Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF History of failed organ transplant on immunosuppression. Subjects with known active infection (infection which is being treated)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adipose Derived Mesenchymal Stem Cells<br>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. | Drug: Adipose Derived Mesenchymal Stem Cells<br>* 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<br>* Other names: AMSC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |