{"id":"human-acellular-vessel-hav","safety":{"commonSideEffects":[{"rate":null,"effect":"Graft thrombosis"},{"rate":null,"effect":"Graft infection"},{"rate":null,"effect":"Anastomotic stenosis"},{"rate":null,"effect":"Aneurysm formation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"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.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:48:02.026Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Vascular access for hemodialysis"},{"name":"Peripheral vascular disease requiring bypass grafting"},{"name":"Coronary artery bypass grafting"}]},"trialDetails":[{"nctId":"NCT03183245","phase":"PHASE3","title":"Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis","status":"COMPLETED","sponsor":"Humacyte, Inc.","startDate":"2017-09-29","conditions":"Renal Failure, End Stage Renal Disease, Hemodialysis","enrollment":242},{"nctId":"NCT03631056","phase":"","title":"Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System Injuries","status":"APPROVED_FOR_MARKETING","sponsor":"Humacyte, Inc.","startDate":"","conditions":"Vascular System Injuries","enrollment":""},{"nctId":"NCT02887859","phase":"PHASE2","title":"Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD","status":"COMPLETED","sponsor":"Humacyte, Inc.","startDate":"2016-12-20","conditions":"Peripheral Artery Disease","enrollment":15},{"nctId":"NCT02644941","phase":"PHASE3","title":"Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis","status":"COMPLETED","sponsor":"Humacyte, Inc.","startDate":"2016-05-24","conditions":"Renal Failure, End Stage Renal Disease, Hemodialysis","enrollment":355},{"nctId":"NCT05908084","phase":"PHASE3","title":"To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis","status":"RECRUITING","sponsor":"Humacyte, Inc.","startDate":"2023-09-07","conditions":"End Stage Renal Disease (ESRD)","enrollment":150},{"nctId":"NCT05873959","phase":"","title":"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","status":"COMPLETED","sponsor":"Humacyte, Inc.","startDate":"2023-05-01","conditions":"Trauma, Trauma Injury, Trauma, Multiple","enrollment":17},{"nctId":"NCT01872208","phase":"NA","title":"Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD","status":"COMPLETED","sponsor":"Humacyte, Inc.","startDate":"2013-10-10","conditions":"Peripheral Arterial Disease, Peripheral Vascular Disease","enrollment":20},{"nctId":"NCT04135417","phase":"PHASE2","title":"Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis","status":"COMPLETED","sponsor":"Humacyte, Inc.","startDate":"2019-11-12","conditions":"Renal Failure, End Stage Renal Disease, Vascular Access","enrollment":30},{"nctId":"NCT03005418","phase":"PHASE2, PHASE3","title":"Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Humacyte, Inc.","startDate":"2018-09-01","conditions":"Trauma, Vascular System Injury","enrollment":72}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["(regulated as a biological product)"],"phase":"phase_3","status":"active","brandName":"Human Acellular Vessel (HAV)","genericName":"Human Acellular Vessel (HAV)","companyName":"Humacyte, Inc.","companyId":"humacyte-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}