9 completed, 3 not yet recruiting, 1 active not recruiting, 1 approved for marketing. 5 Phase 3, 4 Phase 2, 2 Not applicable, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 5 | Completed 3, Active not recruiting 1, Not yet recruiting 1 |
| Phase 2 | 4 | Completed 3, Not yet recruiting 1 |
| Not applicable | 2 | Completed 2 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Not yet recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Evaluate the Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) in Patients With Coronary Artery Disease Requiring Coronary Artery Bypass Grafting (CABG) Humacyte Coronary Tissue Engineered Vessel (CTEV) - Coronary Artery Disease | Phase 2 | Not yet recruiting | Humacyte, Inc. | 10 | 2026-09-01 | 2026-07-28 |
| Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair Acellular Tissue Engineered Vessel - Vascular Injury, Arterial Injury | Phase 4 | Not yet recruiting | Humacyte, Inc. | 125 | 2026-09-01 | 2026-08-13 |
| An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury. Acellular Tissue Engineered Vessel (Symvess) - Vascular Trauma, Arterial Injury | Phase 3 | Not yet recruiting | Humacyte, Inc. | 10 | 2026-09-01 | 2026-08-13 |
| To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis Acellular Tissue Engineered Vessel (ATEV), AVF - End Stage Renal Disease (ESRD) | Phase 3 | Active not recruiting | Humacyte, Inc. | 121 | 2023-09-07 | 2026-06-26 |
| 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 HAV implantation - Trauma, Trauma Injury | Completed | Humacyte, Inc. | 17 | 2023-05-01 | 2024-11-25 | |
| Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis HAV - Renal Failure, End Stage Renal Disease | Phase 2 | Completed | Humacyte, Inc. | 30 | 2019-11-12 | 2024-03-19 |
| Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma Acellular Tissue Engineered Vessel (ATEV) - Trauma, Vascular System Injury | Phase 2 / Phase 3 | Completed | Humacyte, Inc. | 72 | 2018-09-01 | 2026-07-29 |
| Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Human Acellular Vessel (HAV), Arteriovenous fistula (AVF), Hemodialysis - Renal Failure, End Stage Renal Disease | Phase 3 | Completed | Humacyte, Inc. | 242 | 2017-09-29 | 2025-11-20 |
| Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD Human Acellular Vessel (HAV) - Peripheral Artery Disease | Phase 2 | Completed | Humacyte, Inc. | 15 | 2016-12-20 | 2025-04-18 |
| Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis Human Acellular Vessel (HAV), ePTFE graft - Renal Failure, End Stage Renal Disease | Phase 3 | Completed | Humacyte, Inc. | 355 | 2016-05-24 | 2026-08-19 |
| Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD HAV implantation - Peripheral Arterial Disease, Peripheral Vascular Disease | Not applicable | Completed | Humacyte, Inc. | 20 | 2013-10-10 | 2024-11-13 |
| Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease HAVG - End-stage Renal Disease, Kidney Failure, Chronic | Phase 1 | Completed | Humacyte, Inc. | 20 | 2013-05-23 | 2022-08-19 |
| Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD HAVG graft implantation - End-stage Renal Disease, Kidney Failure, Chronic | Not applicable | Completed | Humacyte, Inc. | 40 | 2012-11-22 | 2024-11-13 |
| Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System Injuries Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV) - Vascular System Injuries | Approved for marketing | Humacyte, Inc. | 2025-08-24 | |||
| Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular Disease and Dialysis Access Acellular Tissue Engineered Vessel (ATEV) - Vascular Diseases, End Stage Renal Disease on Dialysis | Temporarily not available | Humacyte, Inc. | 2026-09-15 |
Kidney Failure, Chronic (6) · Renal Insufficiency (4) · Wounds and Injuries (4) · Vascular System Injuries (3) · Accidental Injuries (2) · Peripheral Arterial Disease (2) · Renal Insufficiency, Chronic (2) · Atherosclerosis (1) · Coronary Artery Disease (1) · Kidney Diseases (1) · Multiple Trauma (1) · Peripheral Vascular Diseases (1) · Urologic Diseases (1) · Vascular Diseases (1) · Wounds, Nonpenetrating (1)
Arteriovenous Shunt, Surgical (1) · Renal Dialysis (1) · Social Control, Formal (1)
United States (6) · Poland (4) · Israel (2) · Germany (1) · Portugal (1) · Ukraine (1) · United Kingdom (1)
Shamik Parikh, MD (5) · Shamik Shamik, MD (2) · Lynda H Szczech, MD, MSCE (1)
PMID 27203778, PMID 39565635, PMID 32093913, PMID 37662589, PMID 41140335, PMID 42319856, PMID 42613284
2015 (1)