HAV vs AVF for Hemodialysis Access
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, certain medications like high-dose glucocorticoids and specific immunosuppressive agents are not allowed during the trial.
What data supports the effectiveness of the treatment Arteriovenous fistula (AVF) for Hemodialysis Access?
Is the Human Acellular Vessel (HAV) safe for use in hemodialysis access surgery?
The Human Acellular Vessel (HAV) has been used in complex vascular access surgeries and aneurysm repairs with technical success, especially in high-risk patients who had no other care options. This suggests it may be a safe option for hemodialysis access, although it was used under special circumstances with FDA authorization.12367
How is the treatment with Human Acellular Vessel (HAV) different from other treatments for hemodialysis access?
The Human Acellular Vessel (HAV) is unique because it is a biocompatible, regenerative medicine conduit used when traditional arteriovenous fistulas (AVFs) are not viable due to complications like aneurysms or infections. Unlike standard AVFs, HAVs offer a promising alternative for patients with complex vascular needs, potentially improving safety and effectiveness in high-risk cases.12368
What is the purpose of this trial?
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
Research Team
Shamik Parikh, MD
Principal Investigator
Humacyte, Inc.
Eligibility Criteria
This trial is for adults with end-stage renal disease who are on hemodialysis and suitable for a new forearm or upper arm vascular access. They should not have certain blood conditions, active cancer treatments, severe allergies to aspirin, uncontrolled diabetes, or be pregnant. Participants must agree to use contraception if applicable and have a life expectancy of at least 2 years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a Human Acellular Vessel (HAV) or an arteriovenous fistula (AVF) for hemodialysis access
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Arteriovenous fistula (AVF)
- Human Acellular Vessel (HAV)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Humacyte, Inc.
Lead Sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator
CTI Clinical Trial and Consulting Services
Collaborator