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

Sponsor

Humacyte, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03005418

Collaborator

Atlantic Research Group (Other), U.S. Army Medical Research and Development Command (U.S. Fed)

100

Enrollment

Locations

Arm

Anticipated Duration (Months)

4.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Vascular System Injury	Biological: Human Acellular Vessel (HAV)	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2 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

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

HAV primary patency [30 days]
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
Frequency and Severity of Adverse Events [36 months]

Secondary Outcome Measures

Limb viability (avoidance of amputation; limb cohort only) [36 months]
HAV primary patency [36 months]
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
HAV primary assisted patency [36 months]
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
HAV secondary patency [36 months]
Secondary patency is defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions
Rate of HAV interventions [36 months]
Patient survival [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
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.
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
Aged 18 to 85 years old, inclusive
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
Patient or relative is able, willing and competent to give informed consent
Life expectancy of at least 1 year

Exclusion Criteria:

Mangled Extremity Severity Score (MESS) of ≥ 7
Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)
Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS)

5 or Injury Severity Score (ISS) >60)

HAV may not be used for coronary artery repair
Known pregnant women
Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAV
Previous exposure to HAV
Known participation in any investigational study within the last 30 days
Employees of the sponsor or patients who are employees or relatives of the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jacob Medical Center at UC San Diego	La Jolla	California	United States	92037
2	UCI Medical Center	Orange	California	United States	92868
3	University California, Davis	Sacramento	California	United States	95817
4	Ernest E Moore Shock Trauma Center at Denver Health	Denver	Colorado	United States	80204
5	UF Health Jacksonville	Jacksonville	Florida	United States	32209
6	Ryder Trauma Center	Miami	Florida	United States	33136
7	Tampa General Hospital	Tampa	Florida	United States	33606
8	Grady Memorial Hospital	Atlanta	Georgia	United States	30303
9	R Adams Cowley Baltimore Shock Trauma	Baltimore	Maryland	United States	21201
10	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224
11	Cooper University Hospital	Camden	New Jersey	United States	08103
12	Rutgers New Jersey Medical School	Newark	New Jersey	United States	07103
13	Duke University Hospital	Durham	North Carolina	United States	27705
14	Oregon Health & Science University	Portland	Oregon	United States	97239
15	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19104
16	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
17	University of Tennessee Medical Center	Knoxville	Tennessee	United States	37920
18	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-2735
19	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
20	University of Virginia Health System	Charlottesville	Virginia	United States	22908
21	Shaare Zedek Medical Center	Jerusalem		Israel	9103102

Sponsors and Collaborators

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

Investigators

Study Director: Shamik Parikh, MD, Humacyte, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Humacyte, Inc.

ClinicalTrials.gov Identifier:

NCT03005418

Other Study ID Numbers:

CLN-PRO-V005

First Posted:

Dec 29, 2016

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vascular System Injuries

Wounds and Injuries

Study Results

No Results Posted as of Aug 22, 2022