AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

ConditionEnd Stage Renal Disease

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-85

SponsorHoussam Farres, M.D.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Adipose Derived Mesenchymal Stem CellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Houssam Farres, M.D.

Lead sponsor

Mayo Clinic

Sponsor institution

Source ClinicalTrials.gov

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