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

NCT02887859 | Completed Phase 2 Results DMC

• 1 other identifier: CLN-PRO-V004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (4)

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

  12 months

• Number of Participants With Adverse Events

  12 months

• 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

  12 months

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

  12 months

Secondary Outcomes (15)

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

  12 months

• Changes From Baseline in Hematology Parameters - Hemoglobin

  12 months

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

  12 months

• Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium

  12 months

• Number of Participants With HAV Interventions

  12 months

Other Outcomes (3)

• Patient Survival

  60 months

• Frequency of HAV Remaining as a Functional Conduit in Situ (With or Without Interventions)

  60 months

• Evidence of Aneurysmal Dilatation (Conduit Lumen Diameter >9 mm) or Stenosis of the HAV (>70%) on Routine Clinical US

  60 months

Study Arms (1)

HAV Treatment

EXPERIMENTAL

Human Acellular Vessel (HAV)

Biological: Human Acellular Vessel (HAV)

Interventions

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

HAV Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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.).

Sponsors & Collaborators

• Humacyte, Inc.: lead
• Atlantic Research Group: collaborator

Study Sites (5)

UCSF

San Francisco, California, 94143, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan Vascular Center

Flint, Michigan, 48507, United States

Location

Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Dr. Shamik Parikh, MD, CMO
• Organization: Humacyte Inc.

sparikh@humacyte.com

919-313-9633

Study Officials

• Shamik Shamik, MD

  Humacyte, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 2, 2016
• Study Start: December 20, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2023
• Last Updated: April 18, 2025
• Results First Posted: December 19, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)