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Human Acellular Vessel (HAV)
Human Acellular Vessel (HAV) is a tissue-engineered vascular graft derived from human cells that provides a biocompatible alternative to synthetic or animal-derived vascular conduits for vascular reconstruction.
Human Acellular Vessel (HAV) is a tissue-engineered vascular graft derived from human cells that provides a biocompatible alternative to synthetic or animal-derived vascular conduits for vascular reconstruction. Used for Vascular access for hemodialysis, Peripheral vascular disease requiring bypass grafting, Coronary artery bypass grafting.
At a glance
| Generic name | Human Acellular Vessel (HAV) |
|---|---|
| Also known as | (regulated as a biological product) |
| Sponsor | Humacyte, Inc. |
| Drug class | Tissue-engineered vascular graft |
| Modality | Biologic |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
HAV is manufactured by decellularizing human vascular tissue to create an acellular scaffold that retains the structural and functional properties of native blood vessels while eliminating immunogenic cellular components. This bioengineered construct can be used as a vascular graft for bypass surgery, dialysis access, and other vascular reconstruction applications, with the goal of improving patency and reducing complications compared to conventional grafts.
Approved indications
- Vascular access for hemodialysis
- Peripheral vascular disease requiring bypass grafting
- Coronary artery bypass grafting
Common side effects
- Graft thrombosis
- Graft infection
- Anastomotic stenosis
- Aneurysm formation
Key clinical trials
- Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis (PHASE3)
- Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System Injuries
- Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD (PHASE2)
- Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis (PHASE3)
- To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis (PHASE3)
- An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma
- Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD (NA)
- Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |