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

Primary Purpose

Trauma, Vascular System Injury

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Human Acellular Vessel (HAV)
Sponsored by
Humacyte, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jacob Medical Center at UC San DiegoRecruiting
  • Keck Hospital of University of Southern California (USC)Recruiting
  • Cedars-Sinai Medical CenerRecruiting
  • UCI Medical CenterRecruiting
  • University California, DavisRecruiting
  • University of California San Diego (UCSD) Medical CenterRecruiting
  • Ernest E Moore Shock Trauma Center at Denver HealthRecruiting
  • UF Health JacksonvilleRecruiting
  • Jackson South Medical CenterRecruiting
  • Ryder Trauma CenterRecruiting
  • Tampa General HospitalRecruiting
  • Grady Memorial HospitalRecruiting
  • R Adams Cowley Baltimore Shock Trauma
  • Johns Hopkins Bayview Medical CenterRecruiting
  • Johns Hopkins HospitalRecruiting
  • Mayo ClinicRecruiting
  • Saint Louis University (SLU)Recruiting
  • Cooper University HospitalRecruiting
  • Rutgers New Jersey Medical SchoolRecruiting
  • Duke University HospitalRecruiting
  • Atrium Health Wake Forest Baptist Medical CenterRecruiting
  • Wake Forest School of MedicineRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Penn Presbyterian Medical CenterRecruiting
  • Temple University HospitalRecruiting
  • University of Tennessee Medical Center
  • Vanderbilt University Medical Center
  • The University of Texas - Dell Medical SchoolRecruiting
  • University of Virginia Health SystemRecruiting
  • Soroka Medical Center - Vascular Surgery DepartmentRecruiting
  • Rambam Health Care Campus - Vascular Surgery DepartmentRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • The Chaim Sheba Medical Center - Vascular Surgery DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Human Acellular Vessel (HAV)

Arm Description

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.

Outcomes

Primary Outcome Measures

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
Frequency and Severity of Adverse Events

Secondary Outcome Measures

Limb viability (avoidance of amputation; limb cohort only)
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
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
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
Rate of HAV interventions
Patient survival
HAV remodeling as shown by histopathology of any clinical explants
Frequency of anastomotic bleeding or spontaneous rupture
Frequency of HAV infection
Frequency of HAV thrombosis
Frequency of HAV pseudoaneursym formation
Frequency of HAV aneursym formation
Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)
Frequency of HAV removal

Full Information

First Posted
December 21, 2016
Last Updated
June 8, 2023
Sponsor
Humacyte, Inc.
Collaborators
Atlantic Research Group, U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT03005418
Brief Title
Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humacyte, Inc.
Collaborators
Atlantic Research Group, U.S. Army Medical Research and Development Command

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Vascular System Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Human Acellular Vessel (HAV)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Human Acellular Vessel (HAV)
Intervention Description
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.
Primary Outcome Measure Information:
Title
HAV primary patency
Description
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
Time Frame
30 days
Title
Frequency and Severity of Adverse Events
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Limb viability (avoidance of amputation; limb cohort only)
Time Frame
36 months
Title
HAV primary patency
Description
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
Time Frame
36 months
Title
HAV primary assisted patency
Description
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
Time Frame
36 months
Title
HAV secondary patency
Description
Secondary patency is defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions
Time Frame
36 months
Title
Rate of HAV interventions
Time Frame
36 months
Title
Patient survival
Time Frame
36 months
Title
HAV remodeling as shown by histopathology of any clinical explants
Time Frame
36 months
Title
Frequency of anastomotic bleeding or spontaneous rupture
Time Frame
36 months
Title
Frequency of HAV infection
Time Frame
36 months
Title
Frequency of HAV thrombosis
Time Frame
36 months
Title
Frequency of HAV pseudoaneursym formation
Time Frame
36 months
Title
Frequency of HAV aneursym formation
Time Frame
36 months
Title
Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)
Time Frame
36 months
Title
Frequency of HAV removal
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Taylor
Phone
919-313-9633
Ext
185
Email
etaylor@humacyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Tulchinskiy, MD
Phone
919-313-9633
Email
mtulchinskiy@humacyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamik Parikh, MD
Organizational Affiliation
Humacyte, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Jacob Medical Center at UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
Keck Hospital of University of Southern California (USC)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedars-Sinai Medical Cener
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
UCI Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
University California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego (UCSD) Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Ernest E Moore Shock Trauma Center at Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Name
Jackson South Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Ryder Trauma Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Name
R Adams Cowley Baltimore Shock Trauma
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Louis University (SLU)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
Atrium Health Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Hurie, MD
Email
jhurie@wakehealth.edu
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Withdrawn
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Completed
Facility Name
The University of Texas - Dell Medical School
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Name
Soroka Medical Center - Vascular Surgery Department
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus - Vascular Surgery Department
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center - Vascular Surgery Department
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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