Humacyte, Inc. (HUMA)
Humacyte, Inc. focuses on developing and manufacturing readily available, implantable human tissues engineered in a laboratory setting. These bioengineered tissues are designed to treat a wide array of diseases and conditions across various anatomical locations and therapeutic fields. The company employs its distinct scientific and proprietary technology platform to produce human acellular vessels (HAVs). These investigational HAVs are specifically crafted for universal compatibility, enabling easy implantation into any patient without inducing an immune rejection or an adverse foreign body response. Humacyte is currently building a pipeline of HAVs targeting the substantial market for vascular repair, reconstruction, and replacement. This includes applications such as treating vascular trauma, providing arteriovenous access for hemodialysis, addressing peripheral arterial disease, and facilitating coronary artery bypass grafting. Furthermore, the company is exploring the use of its HAVs for pediatric heart surgeries and for cellular therapeutic delivery, including the transplantation of pancreatic islet cells to manage Type 1 diabetes. Founded in 2004, Humacyte maintains its headquarters in Durham, North Carolina.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
Humacyte, Inc.
- Cash runway at this date: 4mo
- ATEV (Symvess)READOUTCash runway at this date: 6mo
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Not yet recruiting
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 +1
NCT07762794Enrollment125StartSep 2026est.Primary CompletionSep 2030est.CompletionSep 2030est. - Phase 3Completed
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
Human Acellular Vessel (HAV)
Renal Failure, End Stage Renal Disease +2
NCT02644941Enrollment355StartMay 2016Primary CompletionMay 2019CompletionSep 2023 - Phase 3Completed
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
Human Acellular Vessel (HAV)
Renal Failure, End Stage Renal Disease +2
NCT03183245Enrollment242StartSep 2017Primary CompletionApr 2024CompletionJun 2025 - Phase 3Active, not recruiting
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)
End Stage Renal Disease (ESRD)
NCT05908084Enrollment121StartSep 2023Primary CompletionJun 2027est.READOUT • p=0.001CompletionJun 2028est. - Phase 3Not yet recruiting
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 +1
NCT07762313Enrollment10StartSep 2026est.Primary CompletionDec 2028est.CompletionDec 2028est. - Phase 2/3Completed
Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma
Acellular Tissue Engineered Vessel (ATEV)
Trauma, Vascular System Injury
NCT03005418Enrollment72StartSep 2018Primary CompletionSep 2023CompletionMay 2026 - Phase 2Completed
Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD
Human Acellular Vessel (HAV)
Peripheral Artery Disease
NCT02887859Enrollment15StartDec 2016Primary CompletionDec 2020CompletionDec 2023 - Phase 2Completed
Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
HAV
Renal Failure, End Stage Renal Disease +2
NCT04135417Enrollment30StartNov 2019Primary CompletionMay 2021CompletionMar 2022 - Phase 2Not yet recruiting
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
NCT07730528Enrollment10StartSep 2026est.Primary CompletionSep 2030est.CompletionSep 2030est. - Phase 1Completed
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
NCT01840956Enrollment20StartMay 2013Primary CompletionApr 2016CompletionApr 2016 - Not applicableCompleted
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
NCT01744418Enrollment40StartNov 2012Primary CompletionDec 2014CompletionMar 2024 - Not applicableCompleted
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
NCT01872208Enrollment20StartOct 2013Primary CompletionMay 2016CompletionJul 2024 - Expanded accessApproved for marketing
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
NCT03631056Enrollment-Start-Primary Completion-Completion- - ObservationalCompleted
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 +2
NCT05873959Enrollment17StartMay 2023Primary CompletionMay 2023CompletionJan 2024 - Expanded accessTemporarily not available
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
NCT07141641Enrollment-Start-Primary Completion-Completion-
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Not yet recruiting | Acellular Tissue Engineered Vessel | NCT07762794 |
| Phase 3 | Completed | Human Acellular Vessel (HAV) | NCT02644941 |
| Phase 3 | Completed | Human Acellular Vessel (HAV) | NCT03183245 |
| Phase 3 | Active, not recruiting | Acellular Tissue Engineered Vessel (ATEV) | NCT05908084 |
| Phase 3 | Not yet recruiting | Acellular Tissue Engineered Vessel (Symvess) | NCT07762313 |
| Phase 2/3 | Completed | Acellular Tissue Engineered Vessel (ATEV) | NCT03005418 |
| Phase 2 | Completed | Human Acellular Vessel (HAV) | NCT02887859 |
| Phase 2 | Completed | HAV | NCT04135417 |
| Phase 2 | Not yet recruiting | Humacyte Coronary Tissue Engineered Vessel (CTEV) | NCT07730528 |
| Phase 1 | Completed | HAVG | NCT01840956 |
| Not applicable | Completed | HAVG graft implantation | NCT01744418 |
| Not applicable | Completed | HAV implantation | NCT01872208 |
| Expanded access | Approved for marketing | Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV) | NCT03631056 |
| Observational | Completed | HAV implantation | NCT05873959 |
| Expanded access | Temporarily not available | Acellular Tissue Engineered Vessel (ATEV) | NCT07141641 |