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Peripheral Artery DiseasePhase 2NCT02887859

Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD

A Phase 2 study testing Human Acellular Vessel (HAV) in people with Peripheral Artery Disease, run by Humacyte, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when surgically implanted into a leg to improve blood flow in patients with peripheral arterial disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Peripheral Artery Disease
What is being tested?
Human Acellular Vessel (HAV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
5 sitesUnited States
Study dates
20 Dec 2016to Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with disabling symptomatic peripheral arterial disease
  • Rutherford stage 4 or 5 who require femoro-popliteal bypass surgery or
  • Rutherford stage 3 with severe claudication (less than 50 yards AND causing severe impairment of ability to work or undertake social activities)
  • Ankle - brachial index ≤ 0.6 in the study leg
  • Patient has failed adequate medical therapy which included
  • Exercise program
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  • Smoking cessation therapy
  • Control of diabetes, hypertension and dyslipidemias
  • Antiplatelet therapy
  • Preoperative angiography or CT angiography shows superficial femoral artery occlusion AND required Humacyte Human Acellular Vessel (HAV) length of ≤ 38cm. This imaging may have been conducted up to 6 months prior to study entry provided that the patient's symptoms have remained stable since that time
  • Preoperative imaging shows at least one below knee vessel patent to the ankle with good runoff
  • Proximal HAV anastomosis is expected to be to the common femoral artery below the inguinal ligament or to the superficial femoral artery
  • Distal anastomosis is expected to be to the popliteal artery above the knee
  • Femoral artery occlusion is not considered suitable for endovascular treatment; e.g. long segment chronic total occlusion, previous failed stent or stent graft in the superficial femoral artery, previous failed endovascular treatment where the lesion could not be crossed
  • Autologous vein graft is not feasible in the judgment of the treating surgeon; e.g. because all suitable veins have been used previously for coronary or peripheral bypass, or pre-operative vein mapping shows inadequate length or quality of vein to complete the planned bypass
  • Aged 18 to 85 years old, inclusive
  • Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3 at screening
  • Other hematological and biochemical parameters within a range considered acceptable for the administration of general anesthesia at screening
  • Adequate liver function, defined as serum bilirubin ≤ 1.5 mg/dL; and INR ≤ 1.5 at screening
  • Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures
  • Life expectancy of at least 1 year

Who cannot join

  • Leg at high risk of amputation (SVS WIfI stage 4)
  • Recent clinically significant trauma to the leg receiving the HAV
  • Severe active infection (SVS foot infection grade 3) in the leg receiving the HAV
  • Distal anastomosis planned to a below knee artery
  • History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
  • Stroke within six (6) months prior to study entry (Day 1)
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  • Chronic renal disease such that multiple administrations of contrast agents may pose an increased risk of nephrotoxicity (eGFR<45mL/min)
  • Uncontrolled diabetes (HbA1c >10% at screening)
  • Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
  • Cancer that is being actively treated with a cytotoxic agent
  • AIDS / HIV infection
  • Documented hypercoagulable state or history as defined as either:
  • a biochemical diagnosis (e.g. Factor V Leiden, Protein C deficiency, etc.) - OR -
  • a clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g. DVT, PE, etc.) within the previous 5 years
  • Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g. von Willebrand disease, etc.).
  • Ongoing treatment with vitamin K antagonists or oral direct thrombin inhibitors or factor Xa inhibitors (e.g. dabigatran, apixaban or rivaroxaban )
  • Previous arterial bypass surgery (autologous vein or synthetic graft) in the operative leg
  • Stenosis of >50% of the inflow aortoiliac system ipsilateral to the index leg. Any such stenosis must be corrected with angioplasty with or without stenting prior to, or at the time of, HAV implantation
  • Active autoimmune disease - symptomatic or requiring ongoing drug therapy
  • Active local or systemic infection (WBC > 15,000/mm3)
  • Known serious allergy to aspirin
  • Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the Humacyte Human Acellular Vessel (HAV)
  • Previous exposure to HAV
  • Employees of the sponsor or patients who are employees or relatives of the investigator
  • Pregnant women or women planning to become pregnant (Women of child bearing potential, WOCBP, must use adequate contraception [hormonal or barrier method of birth control; abstinence] for the duration of study participation; WOCBP defined as not sterile or not > 1 year postmenopausal.)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Duke University

    Durham, North Carolina, 27708

  • Michigan Vascular Center

    Flint, Michigan, 48507

  • UCSF

    San Francisco, California, 94143

  • Overlook Medical Center

    Summit, New Jersey, 07901

Other trials in United States

About this study

Official title: A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Use as a Vascular Prosthesis for Femoro-Popliteal Bypass in Patients With Peripheral Arterial Disease

This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when surgically implanted into a leg to improve blood flow in patients with peripheral arterial disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.

Read the detailed description

This is a prospective, open label, single treatment arm, multicenter phase 2 study to evaluate the safety and efficacy of the HAV in patients with PAD undergoing femoro-popliteal bypass surgery. The primary objective of this study is to evaluate the safety and tolerability of the HAV in these patients and to determine the patency of the Humacyte HAV at 12 months post-implantation. The secondary objectives of this study are to further assess safety in terms of PRA response, and to determine the rates of HAV interventions required to keep the HAV patent. There is no formal hypothesis testing planned; the study involves only a single, open-label treatment group.

Being tested
Human Acellular Vessel (HAV)
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Acellular Vessel (HAV)Biological

    Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques

Study groups in NCT02887859
Study groupRoleWhat they receive
HAV TreatmentExperimentalHuman Acellular Vessel (HAV)
Receives: Biological: Human Acellular Vessel (HAV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site

    Measured: 12 months

  2. Number of Participants With Adverse Events

    Measured: 12 months

  3. Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary)

    Primary patency = patent ("open" to blood flow) without any interventions; Primary-assisted patency = patent without an intervention to clear a thrombus; Secondary patency = patent with or without interventions

    Measured: 12 months

  4. Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria)

    Measured: 12 months

Secondary outcomes (15)

  1. Number of Participants With a Change in Panel Reactive Antibodies (PRA) From Baseline

    Measured: 12 months

  2. Changes From Baseline in Hematology Parameters - Hemoglobin

    Measured: 12 months

  3. Changes From Baseline in Coagulation Parameters - International Normalized Ratio (INR)

    Measured: 12 months

  4. Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium

    Measured: 12 months

  5. Number of Participants With HAV Interventions

    e.g., angioplasty, thrombectomy, surgical revision

    Measured: 12 months

  6. Mean Vascular Quality of Life Questionnaire (VascuQoL) Score (1-7) for Patients With PAD Symptoms

    scoring per Vascular Quality of Life Questionnaire (VascuQoL) Likert scale: 7, there is 1 (the worst) to 7 (the best possible)

    Measured: 12 months

  7. Ankle Brachial Index (ABI)

    Normal: 1.0 - 1.4 Borderline: 0.9 - 1.0 Mild PAD (peripheral artery disease): 0.8 - 0.9 Moderate PAD: 0.4 - 0.7 Severe PAD: < 0.4

    Measured: 12 months

  8. Six Minute Walk Test - Duration

    Measured: 12 months

  9. Changes From Baseline in Hematology Parameters - Hematocrit

    Measured: 12 months

  10. Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts

    Measured: 12 months

  11. Changes From Baseline in Coagulation Parameters - Activated Partial Thromboplastin Time

    Measured: 12 months

  12. Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose

    Measured: 12 months

  13. Changes From Baseline in Clinical Chemistry Parameters - Albumin

    Measured: 12 months

  14. Six Minute Walk Test - Distance

    Measured: 12 months

  15. Microscopic Evidence of HAV Remodeling (Host Cells Within HAV)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study start20 Dec 2016
  3. Primary completionDec 2020
  4. Study completionDec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887859
Sponsor's protocol ID
CLN-PRO-V004
Status last verified
Mar 2025
First submitted
25 Aug 2016
Last updated
18 Apr 2025
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Human Acellular Vessel (HAV) in people with Peripheral Artery Disease, run by Humacyte, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02887859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.

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