Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

Study Overview
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Brief Summary
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The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.

Official Title
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A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

Conditions
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End Stage Renal Disease (ESRD), Vascular Access Complication

Intervention / Treatment
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* Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
* Drug: Placebo
* Biological: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patient between 18 and 85 years old Patient currently on hemodialysis or pre-dialysis and planned 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 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 Pregnancy or breast feeding 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 Employees of the sponsor or patients who are employees or relatives of the investigator History of failed organ transplant on immunosuppression

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula<br>Subjects who receive a radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) | Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)<br>* A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.<br>|
| No Intervention: No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula<br>Patients receive standard of care. | |
| Experimental: Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula<br>Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at time of first stage of BBF | Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)<br>* A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.<br>|
| Experimental: AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula<br>Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at first and second stage of BBF | Biological: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)<br>* Two topical applications of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period at stage one and two of fistula surgery<br>|
| Placebo Comparator: Placebo treatment in brachiobasilic arteriovenous fistula<br>Subjects will receive placebo at first and second stage of BBF | Drug: Placebo<br>* 5-mL of Lactated Ringers solution topical application to the surface of the outflow vein (right next to the fistula) over a five-minute period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodialysis outflow vein diameter | Diameter of outflow vein by ultrasound | Baseline to 12 months after AVF creation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodialysis AVF Blood flow | blood flow by ultrasound or dialysis | Baseline to 12 months after AVF creation |