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

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