Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma

NCT03005418 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CLN-PRO-V005
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 29

Brief Summary

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

Conditions

Trauma; Vascular System Injury

Outcome Measures

Primary Outcomes (2)

• Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group

  Rate of primary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.

  30 days from time of implantation

• Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup

  Rate of primary patency at 30 days post-implantation, evaluated strictly within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the 30-day evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.

  30 days from time implantation

Secondary Outcomes (34)

• Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group

  30 days from time of implantation

• HAV Infection Free Rate at Day 30 in the All HAV Group

  30 days from time of implantation

• Limb Salvage Rate at Day 30 in the All HAV Group

  30 Days from time of implantation

• Survival Rate at Day 30 in the All HAV Group

  30 Days from time of implantation

• Kaplan-Meier Estimates of Long-term Primary Patency in the All HAV Group

  12 months from time of implantation

Study Arms (1)

Acellular Tissue Engineered Vessel (ATEV)

EXPERIMENTAL

Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte ATEV as an interposition vessel or bypass using standard vascular surgical techniques.

Biological: Acellular Tissue Engineered Vessel (ATEV)

Interventions

Acellular Tissue Engineered Vessel (ATEV) BIOLOGICAL

The investigational medicinal product (IMP) - the Acellular Tissue Engineered Vessel (ATEV) is a sterile acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin which can be used for arterial bypass or reconstruction in patients with life or limb threatening vascular trauma. The vessel is 6 mm in diameter and approximately 42 cm in length. The product is supplied on a silicone mandrel immersed in sterile phosphate buffered saline in a sealed and labeled plastic container. The ATEV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.

Also known as: Human Acellular Vessel (HAV)

Acellular Tissue Engineered Vessel (ATEV)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6 mm Acellular Tissue Engineered Vessel (ATEV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.
• 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
• 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
• Patient or relative is able, willing and competent to give informed consent
• Life expectancy of at least 1 year

You may not qualify if:

• Mangled Extremity Severity Score (MESS) of ≥ 7
• Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)
• Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) \> 5 or Injury Severity Score (ISS) \>60)
• ATEV may not be used for coronary artery repair
• Known pregnant women
• Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the ATEV
• Previous exposure to ATEV
• Known participation in any investigational study within the last 30 days
• Employees of the sponsor or patients who are employees or relatives of the investigator

Sponsors & Collaborators

• Humacyte, Inc.: lead
• Atlantic Research Group: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (29)

Jacob Medical Center at UC San Diego

La Jolla, California, 92037, United States

Location

Keck Hospital of University of Southern California (USC)

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Cener

Los Angeles, California, 90048, United States

Location

UCI Medical Center

Orange, California, 92868, United States

Location

University California, Davis

Sacramento, California, 95817, United States

Location

University of California San Diego (UCSD) Medical Center

San Diego, California, 92103, United States

Location

Ernest E Moore Shock Trauma Center at Denver Health

Denver, Colorado, 80204, United States

Location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Jackson South Medical Center

Miami, Florida, 33136, United States

Location

Ryder Trauma Center

Miami, Florida, 33136, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

R Adams Cowley Baltimore Shock Trauma

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Louis University (SLU)

St Louis, Missouri, 63110, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

The University of Texas - Dell Medical School

Austin, Texas, 78701, United States

Location

Soroka Medical Center - Vascular Surgery Department

Beersheba, 8410101, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Related Publications (2)

• Lum Y, Moore EE, Kundi R, Morrison J, Shores JT, Niklason LE, Parikh S. Bioengineered human blood vessels to treat hospital-acquired vascular complications. J Vasc Surg Cases Innov Tech. 2025 Sep 8;11(6):101976. doi: 10.1016/j.jvscit.2025.101976. eCollection 2025 Dec.

  PMID: 41140335 DERIVED

• Moore EE, Curi M, Namias N, Kundi R, Lum YW, Fox CJ, Rajani RR, Rasmussen TE, Sokolov O, Niklason LE, Khondker Z, Parikh SJ; CLN-PRO-V005 Investigators and the CLN-PRO-V017 Investigators. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA Surg. 2025 Feb 1;160(2):181-189. doi: 10.1001/jamasurg.2024.4893.

  PMID: 39565635 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Vascular System Injuries

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Intercurrent events (e.g., dropout, death, etc.) led to missing outcomes data for some patients. An independent adjudication committee adjudicated the events for last known outcome status and the relationship. While-on-treatment strategy was applied to impute the missing data for those intercurrent events adjudicated to be unrelated to the outcome.

Results Point of Contact

• Title: Shamik Parikh, Chief Medical Officer
• Organization: Humacyte Global, Inc.

sparikh@humacyte.com

(919) 313-9633

Study Officials

• Shamik Parikh, MD

  Humacyte, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 29, 2016
• Study Start: September 1, 2018
• Primary Completion: September 19, 2023
• Study Completion: May 15, 2026
• Last Updated: July 29, 2026
• Results First Posted: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); US (27)