Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma

NCT03005418 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CLN-PRO-V005
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 32

Brief Summary

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.

Conditions

Trauma; Vascular System Injury

Outcome Measures

Primary Outcomes (2)

• HAV primary patency

  Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions

  30 days

• Frequency and Severity of Adverse Events

  36 months

Secondary Outcomes (14)

• Limb viability (avoidance of amputation; limb cohort only)

  36 months

• HAV primary patency

  36 months

• HAV primary assisted patency

  36 months

• HAV secondary patency

  36 months

• Rate of HAV interventions

  36 months

Study Arms (1)

Human Acellular Vessel (HAV)

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 Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques.

Biological: Human Acellular Vessel (HAV)

Interventions

Human Acellular Vessel (HAV) BIOLOGICAL

The investigational medicinal product (IMP) - the Human Acellular Vessel (HAV) 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 Humacyte HAV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.

Human Acellular Vessel (HAV)

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 6mm Human Acellular Vessel (HAV) 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
• Aged 18 to 85 years old, inclusive
• 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)
• HAV 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 HAV
• Previous exposure to HAV
• 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 (32)

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

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Soroka Medical Center - Vascular Surgery Department

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus - Vascular Surgery Department

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

The Chaim Sheba Medical Center - Vascular Surgery Department

Ramat Gan, 5265601, 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

Study Officials

• Shamik Parikh, MD

  Humacyte, Inc.

  STUDY DIRECTOR

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 (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4); US (28)