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Phase II Clinical Trial for
Peripheral Arterial Disease

ATTENTION CLINICIAN: The purpose of this website is to alert you that this patient is enrolled in the Humacyte Phase II Clinical Trial for Peripheral Arterial Disease (PAD). This patient’s peripheral bypass conduit is the Humacyte Human Acellular Vessel (HAV).

PRIOR TO INTERVENTION: We request that you read Intervention Guidelines and refer to the Medical Monitor phone number listed below if you have questions regarding interventions to this investigational peripheral bypass conduit.

Be advised, balloon for angioplasty or thrombectomy SHOULD NOT EXCEED 6MM in diameter within the HAV as disruption or tearing of HAV may occur.

Humacyte Phase II Clinical Trial for PAD

STUDY POPULATION:
Patients with disabling, symptomatic PAD who have failed conservative therapy and who are being considered for peripheral bypass.

PRIMARY OBJECTIVE:
To evaluate the safety and tolerability of the Humacyte HAV in PAD patients undergoing femoro-popliteal bypass surgery.

STUDY SITES:
Approximately 4 Sites in the US

ENROLLMENT: 
At least 20 patients

ENROLLMENT PERIOD:
Approximately 12 months

EXPECTED START DATE:
August 2016

FOLLOW UP PERIOD:
Up to 5 years

SPONSOR:
Humacyte, Inc.

CONTACT:
Medical Monitor 188-619-3216

The Humacyte Phase II clinical trial will evaluate the safety and tolerability of the Humacyte HAV when used for peripheral (femoral to above-the-knee popliteal artery) bypass in the PAD study population. Below you can learn more about the Humacyte technology, the Phase II PAD clinical trial, or Phase II AV Access clinical trial results.

Ver 1.0 8Jul2016

Phase II PAD Clinical Trial Synopsis

Official Title of the Clinical Trial:

A Phase II 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 (PAD)

Subjects with symptomatic peripheral arterial disease as evidenced by claudication, rest pain or critical limb ischemia, and who are being considered for femoro-popliteal bypass surgery will be chosen to participate in this prospective, multicenter, single arm, non-randomized study. Subjects must have previously failed conservative measures to relieve PAD symptoms and do not have adequate autogenous venous conduit available for bypass. All subjects will be implanted with an HAV in a standard infra-inguinal artery to above-the-knee artery bypass configuration, and will be required to take daily aspirin unless they are already taking another antiplatelet agent.

The active study duration for each study participant will be 12 months from HAV implantation or until HAV failure/ HAV removal/ death if earlier. Additional follow up until 60 months post-implantation will involve the capture of information on assessments performed during “standard of care” routine clinic visits (normally every 6 – 12 months depending on the clinical circumstances, but at least every 12 months).

PRIMARY OBJECTIVES:

Safety
  • To evaluate the safety and tolerability of the Humacyte HAV in patients with peripheral arterial disease (PAD) undergoing femoro-popliteal bypass surgery
Efficacy
  • To determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAV at Month 12
  • To determine the incidence of hemodynamically significant stenosis (>70%) defined by duplex ultrasound, and the time to stenosis development

Ver 1.0 8Jul2016

Humacyte Vessel

The HUMACYTE HAV is a tissue-engineered blood vessel that is being investigated as a surgical option for vascular access. The HAV is a sterile, vascular tube, composed of human connective tissue and proteins. This complex connective tissue has similarities to human vascular tissue but HAV is non-living. To date, the HAV has been implanted in over 250 patients worldwide in clinical trials.

To read more about the Humacyte HAV, click here.

Phase II Clinical Trial Results

The following clinical data were adapted from the Humacyte Phase II clinical trial results as reported by Lawson, et al. The Lancet, May 2016.

Two, single arm Phase II clinical trials were conducted in adults in the US and Poland to evaluate the safety and efficacy of the novel bioengineered HAV when implanted into the arms of patients with ESRD who were deemed not suitable for fistula creation to create a vascular access for dialysis.

Primary endpoints were safety (freedom from immune response/infection, aneurysm, or mechanical failure, incidence of adverse events). Efficacy was assessed by primary, primary assisted and secondary patencies at 6 months. Secondary endpoints included patency and intervention rates at 12, 18 and 24 months, and changes in panel reactive antibodies (PRA) following HAV implantation. During the course of the trial, 60 HAVs were implanted into the arms of 60 patients at 6 centers across the US and Poland with planned 24 months of follow up. All patients in this report were followed for at least 1 year, or had a censoring event.

Conclusion: The results of the Phase II clinical trials provide evidence of the potential safety and effectiveness of the bioengineered HAV when used for hemodialysis access as well as evidence of HAV repopulation with host vascular cells, but warrant further study in randomized controlled clinical trials.

US / POLAND
COMBINED

NUMBER OF PATIENTS IMPLANTED

60

PATENCY - NUMBER (%)

PRIMARY PATENCY

6 MONTHS36 (63%)

12 MONTHS15 (28%)

PRIMARY ASSISTED PATENCY

6 MONTHS41 (73%)

12 MONTHS20 (38%)

SECONDARY PATENCY

6 MONTHS54 (97%)

12 MONTHS 46 (89%)

INTERVENTIONS (PER PATIENT YEAR)

1.89

HAV INFECTION, NUMBER (%PPY)

1(1.3%)

Content approved by WIRB 28May2016