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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Trauma; Vascular System Injury
• Intervention / Treatment: Biological: Human Acellular Vessel (HAV)

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).

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Elizabeth Taylor; Phone Number: 185 919-313-9633; Email: etaylor@humacyte.com
• Study Contact Backup: Name: Mark Tulchinskiy, MD; Phone Number: 919-313-9633; Email: mtulchinskiy@humacyte.com

Study Locations

• Israel
  • Be'er Sheva, Israel, 8410101
    • Soroka Medical Center - Vascular Surgery Department
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus - Vascular Surgery Department
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Ramat Gan, Israel, 5265601
    • The Chaim Sheba Medical Center - Vascular Surgery Department
• United States
  • California
    • La Jolla, California, United States, 92037
      • Jacob Medical Center at UC San Diego
    • Los Angeles, California, United States, 90033
      • Keck Hospital of University of Southern California (USC)
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Cener
    • Orange, California, United States, 92868
      • UCI Medical Center
    • Sacramento, California, United States, 95817
      • University California, Davis
    • San Diego, California, United States, 92103
      • University of California San Diego (UCSD) Medical Center
  • Colorado
    • Denver, Colorado, United States, 80204
      • Ernest E Moore Shock Trauma Center at Denver Health
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Uf Health Jacksonville
    • Miami, Florida, United States, 33136
      • Ryder Trauma Center
    • Miami, Florida, United States, 33136
      • Jackson South Medical Center
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
    • Baltimore, Maryland, United States, 21201
      • R Adams Cowley Baltimore Shock Trauma
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University (SLU)
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Newark, New Jersey, United States, 07103
      • Rutgers New Jersey Medical School
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Hospital
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78701
      • The University of Texas - Dell Medical School
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient survival		36 months
Limb viability (avoidance of amputation; limb cohort only)		36 months
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	36 months
HAV primary assisted patency	Primary assisted patency is defined as 'the interval from the time of access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of patent access' i.e., patent without an intervention to clear a thrombus	36 months
HAV secondary patency	Secondary patency is defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions	36 months
Rate of HAV interventions		36 months
HAV remodeling as shown by histopathology of any clinical explants		36 months
Frequency of anastomotic bleeding or spontaneous rupture		36 months
Frequency of HAV infection		36 months
Frequency of HAV thrombosis		36 months
Frequency of HAV pseudoaneursym formation		36 months
Frequency of HAV aneursym formation		36 months
Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)		36 months
Frequency of HAV removal		36 months

Collaborators and Investigators

• Sponsor: Humacyte, Inc.
• Collaborators: U.S. Army Medical Research and Development Command; Atlantic Research Group
• Investigators: Study Director: Shamik Parikh, MD, Humacyte, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimated): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Vascular System Injuries
• Other Study ID Numbers: CLN-PRO-V005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No