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



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 85
Updated:1/19/2019
Start Date:September 1, 2018
End Date:September 2023
Contact:Angela Rose, MBA
Email:rose@humacyte.com
Phone:919-313-9633

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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

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.

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).

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
We found this trial at
6
sites
4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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1800 NW 10th Ave
Miami, Florida 33136
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Baltimore, Maryland 21201
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777 Bannock St
Denver, Colorado 80204
(303) 436-6000
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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Newark, New Jersey 07103
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Newark, NJ
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