End Stage Renal Disease (ESRD), Vascular Access Complication
Conditions
Brief summary
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.
Interventions
BIOLOGICALSingle Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
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.
DRUGPlacebo
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.
BIOLOGICALTwo Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
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
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodialysis outflow vein diameter | Baseline to 12 months after AVF creation | Diameter of outflow vein by ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodialysis AVF Blood flow | Baseline to 12 months after AVF creation | blood flow by ultrasound or dialysis |
Countries
United States
Outcome results
None listed