Recruiting
Phase 1

AMSC

Sponsor:

Houssam Farres, M.D.

Code:

NCT04392206

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Adipose Derived Mesenchymal Stem Cells

Study Details

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.

Conditions

End Stage Renal Disease

Study ID

NCT04392206

Start date

May 15, 2020

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adipose Derived Mesenchymal Stem Cells

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.

Interventions

Adipose Derived Mesenchymal Stem Cells

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

Primary outcome measure

  • Number of participants with treatment-related adverse events [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Reagan Dukes

(904) 953-2077Dukes.Reagan@mayo.edu

Mauricia Buchanan

(904) 953-2077buchanan.mauricia@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Mauricia Buchanan

904-953-2077Buchanan.Mauricia@mayo.edu

More Information

Sponsor

Houssam Farres, M.D.

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Houssam Farres, M.D. on 2026-07-10.