Clinical trial NCT03005418: Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Trauma
Vascular System Injury
Lead sponsor: Humacyte, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Atlantic Research Group
name: U.S. Army Medical Research and Development Command
First posted: 2016-12-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: HAV primary patency
timeFrame: 30 days
measure: Frequency and Severity of Adverse Events
timeFrame: 36 months
Secondary outcomes:
measure: Limb viability (avoidance of amputation; limb cohort only)
timeFrame: 36 months
measure: HAV primary patency
timeFrame: 36 months
measure: HAV primary assisted patency
timeFrame: 36 months
measure: HAV secondary patency
timeFrame: 36 months
measure: Rate of HAV interventions
timeFrame: 36 months
measure: Patient survival
timeFrame: 36 months
measure: HAV remodeling as shown by histopathology of any clinical explants
timeFrame: 36 months
measure: Frequency of anastomotic bleeding or spontaneous rupture
timeFrame: 36 months
measure: Frequency of HAV infection
timeFrame: 36 months
measure: Frequency of HAV thrombosis
timeFrame: 36 months
measure: Frequency of HAV pseudoaneursym formation
timeFrame: 36 months
measure: Frequency of HAV aneursym formation
timeFrame: 36 months
measure: Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)
timeFrame: 36 months
measure: Frequency of HAV removal
timeFrame: 36 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Jacob Medical Center at UC San Diego
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of University of Southern California (USC)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Cener
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: Sacramento
country: United States
facility: University California, Davis
state: California
city: San Diego
country: United States
facility: University of California San Diego (UCSD) Medical Center
state: California
city: Denver
country: United States
facility: Ernest E Moore Shock Trauma Center at Denver Health
state: Colorado
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Miami
country: United States
facility: Jackson South Medical Center
state: Florida
city: Miami
country: United States
facility: Ryder Trauma Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Baltimore
country: United States
facility: R Adams Cowley Baltimore Shock Trauma
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University (SLU)
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: The University of Texas - Dell Medical School
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center - Vascular Surgery Department
city: Haifa
country: Israel
facility: Rambam Health Care Campus - Vascular Surgery Department
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center - Vascular Surgery Department
Study officials:
affiliation: Humacyte, Inc.
name: Shamik Parikh, MD
role: STUDY_DIRECTOR
References: