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NCT02808208 Clinical Trial

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

Vascular Access Complication Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02808208
Other study ID # 15-009053
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 7, 2017
Est. completion date December 2024

Study information
Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 74
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Single 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.
Drug:
• Placebo
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.
Biological:
• Two 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

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemodialysis outflow vein diameter Diameter of outflow vein by ultrasound Baseline to 12 months after AVF creation
Secondary Hemodialysis AVF Blood flow blood flow by ultrasound or dialysis Baseline to 12 months after AVF creation
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