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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03005418
• Other study ID #: CLN-PRO-V005
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2018
• Est. completion date: September 1, 2027

Study information

• Verified date: October 2023
• Source: Humacyte, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma
• Vascular System Injuries
• Vascular System Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Israel	Soroka Medical Center - Vascular Surgery Department	Be'er Sheva
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
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	The University of Texas - Dell Medical School	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	R Adams Cowley Baltimore Shock Trauma	Baltimore	Maryland
United States	Cooper University Hospital	Camden	New Jersey
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Ernest E Moore Shock Trauma Center at Denver Health	Denver	Colorado
United States	Duke University Hospital	Durham	North Carolina
United States	UF Health Jacksonville	Jacksonville	Florida
United States	Jacob Medical Center at UC San Diego	La Jolla	California
United States	Cedars-Sinai Medical Cener	Los Angeles	California
United States	Keck Hospital of University of Southern California (USC)	Los Angeles	California
United States	Jackson South Medical Center	Miami	Florida
United States	Ryder Trauma Center	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Rutgers New Jersey Medical School	Newark	New Jersey
United States	UCI Medical Center	Orange	California
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University California, Davis	Sacramento	California
United States	Saint Louis University (SLU)	Saint Louis	Missouri
United States	University of California San Diego (UCSD) Medical Center	San Diego	California
United States	Tampa General Hospital	Tampa	Florida
United States	Atrium Health Wake Forest Baptist Medical Center	Winston-Salem	North Carolina
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Humacyte, Inc.	Atlantic Research Group, U.S. Army Medical Research and Development Command

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Frequency and Severity of Adverse Events		36 months
Secondary	Limb viability (avoidance of amputation; limb cohort only)		36 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of HAV interventions		36 months
Secondary	Patient survival		36 months
Secondary	HAV remodeling as shown by histopathology of any clinical explants		36 months
Secondary	Frequency of anastomotic bleeding or spontaneous rupture		36 months
Secondary	Frequency of HAV infection		36 months
Secondary	Frequency of HAV thrombosis		36 months
Secondary	Frequency of HAV pseudoaneursym formation		36 months
Secondary	Frequency of HAV aneursym formation		36 months
Secondary	Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)		36 months
Secondary	Frequency of HAV removal		36 months