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

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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 2 Interventional 18 - 85 Years Humacyte, Inc. CLN-PRO-V004
NCT02887859
Enrolling patients

Study Design:


Principal Investigator

Professor and Chief,
Division of Vascular & Endovascular Surgery
Edwin J. Wylie, M.D. Chair in Vascular Surgery
Co-Director, UCSF Heart and Vascular Center
Co-Director, UCSF Center for Limb Preservation

Clinical Research Coordinator

UCSF Medical Center at Parnassus
(415) 353-4379 Phone
(415) 353-4370 Fax

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.

Eligibility

Inclusion Criteria:

     1. 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)
     2. Ankle - brachial index ≤ 0.6 in the study leg
     3. Patient has failed adequate medical therapy which included
       Exercise program
       Smoking cessation therapy
       Control of diabetes, hypertension and dyslipidemias
       Antiplatelet therapy
     4. Preoperative angiography or CT angiography shows superficial femoral artery occlusion
         AND required Humacyte Human Acellular Vessel (HAV) length of ≤ 40cm. 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
     5. Preoperative imaging shows at least one below knee vessel patent to the ankle with
         good runoff
     6. Proximal HAV anastomosis is expected to be to the common femoral artery below the
         inguinal ligament or to the superficial femoral artery
     7. Distal anastomosis is expected to be to the popliteal artery above the knee
     8. 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
     9. 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
     10. Aged 18 to 85 years old, inclusive
     11. Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3 at screening
     12. Other hematological and biochemical parameters within a range considered acceptable
         for the administration of general anesthesia at screening
     13. Adequate liver function, defined as serum bilirubin ≤ 1.5 mg/dL; GGT ≤ 3x upper limit
         of normal ; AST, ALT, and alkaline phosphatase ≤ 2x upper limit of normal and INR ≤
         1.5 at screening
     14. Able to communicate meaningfully with investigative staff, competent to give written
         informed consent, and able to comply with entire study procedures
     15. Life expectancy of at least 1 year
Exclusion Criteria:

     1. Leg at high risk of amputation (SVS WIfI stage 4)
     2. Recent trauma to the leg receiving the HAV
     3. Severe active infection (SVS foot infection grade 3) in the leg receiving the HAV
     4. Distal anastomosis planned to a below knee artery
     5. 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
     6. Stroke within six (6) months prior to study entry (Day 1)
     7. Chronic renal disease such that multiple administrations of contrast agents may pose
         an increased risk of nephrotoxicity (eGFR<45mL/min)
     8. Uncontrolled diabetes (HbA1c >10% at screening)
     9. Treatment with any investigational drug or device within 60 days prior to study entry
         (Day 1)
     10. Cancer that is being actively treated with a cytotoxic agent
     11. AIDS / HIV infection
     12. Documented hypercoagulable state or history of 3 or more DVTs or other spontaneous
         intravascular thrombotic events within the previous 5 years
     13. Bleeding diathesis
     14. Ongoing treatment with vitamin K antagonists or oral direct thrombin inhibitors or
         factor Xa inhibitors (e.g. dabigatran, apixaban or rivaroxaban )
     15. Previous arterial bypass surgery (autologous vein or synthetic graft) in the
         operative leg
     16. 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
     17. Active autoimmune disease - symptomatic or requiring ongoing drug therapy
     18. Active local or systemic infection (WBC > 15,000/mm3)
     19. Known serious allergy to aspirin
     20. 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)
     21. Previous enrollment in this study
     22. Employees of the sponsor or patients who are employees or relatives of the
         investigator
     23. 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.)

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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 3/21/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
X