AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

NCT04392206 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 19-007203
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events

  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

Study Arms (1)

Adipose Derived Mesenchymal Stem Cells

EXPERIMENTAL

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

Interventions

Adipose Derived Mesenchymal Stem Cells DRUG

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

Also known as: AMSC

Adipose Derived Mesenchymal Stem Cells

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Houssam Farres, M.D.: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Houssam Farres, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reagan Dukes

CONTACT

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

Mauricia Buchanan

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 18, 2020
• Study Start: May 15, 2020
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)