A Phase 2/3 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma

CLN-PRO-V005

This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.

2018-09-01

2027-09-01

2027-09-01

Active (not recruiting)

Early phase I

72

Inclusion Criteria: 1. Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction 2. Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm Human Acellular Vessel (HAV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations. 3. Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization 4. Aged 18 to 85 years old, inclusive 5. Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures 6. Patient or relative is able, willing and competent to give informed consent 7. Life expectancy of at least 1 year Exclusion Criteria: 1. Mangled Extremity Severity Score (MESS) of ≥ 7 2. Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury) 3. Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) \> 5 or Injury Severity Score (ISS) \>60) 4. HAV may not be used for coronary artery repair 5. Known pregnant women 6. Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries 7. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAV 8. Previous exposure to HAV 9. Known participation in any investigational study within the last 30 days 10. Employees of the sponsor or patients who are employees or relatives of the investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

2023-11-02