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

NCT ID: NCT03005418

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2027-09-01

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.

Detailed Description

This is a prospective, multicenter, multi cohort, non-randomized phase 2 study in up to 40 adult patients with life or limb threatening vascular trauma which requires surgical repair. There will be a limb cohort and a torso cohort. The limb cohort will include patients who require repair of a vessel contained to the upper or lower extremity. The torso cohort includes patients who require repair of vessels within the thorax (excluding the heart), abdomen, and retroperitoneum. Subjects will be implanted with a Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.

The active study duration for each study participant will be 36 months from HAV implantation or until HAV failure/ removal/ death if earlier. Follow up after month 12 will involve the capture of information on assessments performed at "standard of care" routine clinic visits or by telephone follow up with the patient or his/her physician with physical exam and ultrasound at month 24 and month 36

The total expected duration of the clinical study is 61 months (24 months of enrollment and 36 months of follow up).

Conditions

Trauma; Vascular System Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human Acellular Vessel (HAV)

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.

Group Type: EXPERIMENTAL

Human Acellular Vessel (HAV)

Intervention Type: 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.

Interventions

Human Acellular Vessel (HAV)

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlantic Research Group

OTHER

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Humacyte, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shamik Parikh, MD

Role: STUDY_DIRECTOR

Humacyte, Inc.

Locations

Jacob Medical Center at UC San Diego

La Jolla, California, United States

Keck Hospital of University of Southern California (USC)

Los Angeles, California, United States

Cedars-Sinai Medical Cener

Los Angeles, California, United States

UCI Medical Center

Orange, California, United States

University California, Davis

Sacramento, California, United States

University of California San Diego (UCSD) Medical Center

San Diego, California, United States

Ernest E Moore Shock Trauma Center at Denver Health

Denver, Colorado, United States

UF Health Jacksonville

Jacksonville, Florida, United States

Jackson South Medical Center

Miami, Florida, United States

Ryder Trauma Center

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Grady Memorial Hospital

Atlanta, Georgia, United States

R Adams Cowley Baltimore Shock Trauma

Baltimore, Maryland, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Louis University (SLU)

St Louis, Missouri, United States

Cooper University Hospital

Camden, New Jersey, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Duke University Hospital

Durham, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The University of Texas - Dell Medical School

Austin, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Soroka Medical Center - Vascular Surgery Department

Beersheba, , Israel

Rambam Health Care Campus - Vascular Surgery Department

Haifa, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

The Chaim Sheba Medical Center - Vascular Surgery Department

Ramat Gan, , Israel

Countries

United States; Israel

References

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.

Reference Type: DERIVED

PMID: 41140335 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39565635 (View on PubMed)

Other Identifiers

CLN-PRO-V005

Identifier Type: -

Identifier Source: org_study_id