AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

NCT ID: NCT04392206

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2027-06-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adipose Derived Mesenchymal Stem Cells

Intervention Type: 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

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

Intervention Type: DRUG

Other Intervention Names

AMSC

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Houssam Farres, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Houssam Farres, M.D.

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Houssam Farres, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Reagan Dukes

Role: CONTACT

Dukes.Reagan@mayo.edu

(904) 953-2077

Mauricia Buchanan

Role: CONTACT

buchanan.mauricia@mayo.edu

(904) 953-2077

Facility Contacts

Mauricia Buchanan

Role: primary

Buchanan.Mauricia@mayo.edu

904-953-2077

Other Identifiers

19-007203

Identifier Type: -

Identifier Source: org_study_id