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Patients

Phase II Clinical Trial for
Peripheral Arterial Disease

Humacyte Phase II Clinical Trial for PAD

PRIMARY OBJECTIVE:
Patients with disabling, symptomatic peripheral arterial disease (PAD) who have failed conservative therapy and who are being considered for peripheral bypass.

STUDY SITES:
Approximately 4 Sites in the US.

ENROLLMENT PERIOD:
Approximately 12 months

STUDY START DATE:
August 2016

FOLLOW UP PERIOD:
Up to 5 years

CONTACT:
Local Study coordinator

Thank you for being a part of the Humacyte Phase II Peripheral Bypass clinical trial for PAD and for your willingness to participate in important clinical research. This Phase II study will evaluate the safety and tolerability of the Humacyte HAV when used for peripheral bypass for patients with PAD. Below you can learn more about the Phase II PAD clinical trial, the Humacyte vessel and our technology.

Ver 1.0 8Jul2016

Phase II PAD Clinical Trial Synopsis

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 PAD as evidenced by claudication (leg/muscle pain with walking), rest pain (pain in the legs even without exercise) or critical limb ischemia (non-healing sores or ulcers on the feet or toes, requiring urgent improvement of the blood flow), and who are being considered for arterial bypass surgery of the affected leg, will be chosen to participate in this prospective, multicenter, single arm, non-randomized study. Subjects must have previously failed conservative measures (such as exercise/walking therapy, smoking cessation, and/or use of aspirin or other anti-platelet medicines such as Plavix®) to relieve PAD symptoms and do not have adequate veins to use for bypass surgery. All subjects will have their bypass completed with an HAV in a standard lower extremity surgical arterial bypass configuration, and will be required to take daily aspirin unless he or she is 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. 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).

SCHEDULE OF STUDY SPECIFIC VISITS

  • Screening Visit (up to 35 days
    prior to surgery date)
  • Day 1 (Surgery day)
  • Post op Day 5
  • 1 month
  • 3 months
  • 6 months
  • 9 months
  • 1 year
  • Any standard of care vascular
    surgery clinic follow up visit as
    agreed upon by the investigator
    and study subject that occurs
    over the remaining 4 years.
All visits include:
  • A general physical exam
  • Evaluation of the study bypass vessel
  • Documentation of:
    • Problems
    • Work done to the study bypass vessel (if applicable)
    • Perm cath placement
    • Medications
Some visits will include:
  • Ultrasound imaging of the study
    access
  • 6 minute walk test
  • Lab work

Ver 1.0 8Jul2016

Humacyte Vessel

The HUMACYTE HAV is a tissue-engineered blood vessel that is being investigated as a surgical option for peripheral arterial bypass. 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 read more about the Humacyte HAV, click here.