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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03005418
Other study ID # CLN-PRO-V005
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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