AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

July 8, 2026 updated by: Houssam Farres, M.D.

A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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
Other Names:
  • AMSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Houssam Farres, M.D.

Investigators

  • Principal Investigator: Houssam Farres, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-007203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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