End Stage Renal Disease
Conditions
Brief summary
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.
Interventions
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
Sponsors
Houssam Farres, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events | 12 months | 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. |
Countries
United States
Contacts
CONTACTReagan Dukes
CONTACTMauricia Buchanan
PRINCIPAL_INVESTIGATORHoussam Farres, MD
Mayo Clinic
Outcome results
None listed