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

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ClinicalTrials.gov Identifier: NCT03005418
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : December 8, 2021
Sponsor:
Collaborators:
Atlantic Research Group
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Humacyte, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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 : September 1, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Limb Cohort
Patients with limb-threatening vascular trauma in an extremity will be implanted with a 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) is a Humacyte Human Acellular Vessel (HAV), which is a tissue-engineered vascular prosthesis for arterial bypass or reconstruction in patients with peripheral arterial disease or peripheral arterial trauma. It is a sterile, non-pyrogenic acellular tubular vessel composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin. 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.
Experimental: Torso Cohort
Patients with life-threatening vascular trauma in the torso will be implanted with a 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) is a Humacyte Human Acellular Vessel (HAV), which is a tissue-engineered vascular prosthesis for arterial bypass or reconstruction in patients with peripheral arterial disease or peripheral arterial trauma. It is a sterile, non-pyrogenic acellular tubular vessel composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin. 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
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Primary Outcome Measures :
  1. HAV primary patency [ Time Frame: 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

  2. Frequency and Severity of Adverse Events [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Limb viability (avoidance of amputation; limb cohort only) [ Time Frame: 36 months ]
  2. HAV primary patency [ Time Frame: 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

  3. HAV primary assisted patency [ Time Frame: 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

  4. HAV secondary patency [ Time Frame: 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

  5. Rate of HAV interventions [ Time Frame: 36 months ]
  6. Patient survival [ Time Frame: 36 months ]
  7. HAV remodeling as shown by histopathology of any clinical explants [ Time Frame: 36 months ]
  8. Frequency of anastomotic bleeding or spontaneous rupture [ Time Frame: 36 months ]
  9. Frequency of HAV infection [ Time Frame: 36 months ]
  10. Frequency of HAV thrombosis [ Time Frame: 36 months ]
  11. Frequency of HAV pseudoaneursym formation [ Time Frame: 36 months ]
  12. Frequency of HAV aneursym formation [ Time Frame: 36 months ]
  13. Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria) [ Time Frame: 36 months ]
  14. Frequency of HAV removal [ Time Frame: 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005418


Contacts
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Contact: Elizabeth Taylor 919-313-9633 ext 185 etaylor@humacyte.com
Contact: Lynda Szczech, MD, MSCE 919-313-9633 ext 290 lszczech@humacyte.com

Locations
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Sponsors and Collaborators
Humacyte, Inc.
Atlantic Research Group
U.S. Army Medical Research and Development Command
Investigators
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Study Director: Lynda Szczech, MD, MSCE Humacyte, Inc.
More Information
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Responsible Party: Humacyte, Inc.
ClinicalTrials.gov Identifier: NCT03005418    
Other Study ID Numbers: CLN-PRO-V005
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vascular System Injuries
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases