Bioengineered Vessel for Vascular Surgery

New Biologic Vessel Studied for Its Promise for Patients with Advanced Peripheral Arterial Disease and End Stage Renal Disease

Vascular surgeons at Brigham and Women’s Hospital (BWH) are at the forefront of several trials of a novel tissue-engineered vascular conduit that may alleviate challenges seen with synthetic vascular grafts and autologous vessels.

“This is the first truly bioengineered vessel that has reached this stage of clinical development for vascular use,” according to Michael Belkin, MD, Chief of the Division of Vascular and Endovascular Surgery. “We are hopeful that the vessel will demonstrate advantages over the currently available treatment options for patients with PAD and ESRD.”

Composed of human collagen and other extracellular matrix proteins, the vessel is built by human cells. Then, it undergoes a multi-step process to clear the cells, cellular debris, and antigenic material that could lead to immune response. A recently completed Phase II study showed no detectable immune response from study subjects.

Earlier studies of the vessel also suggest that the collagen matrix comprising the vessel may be infiltrated and remodeled with host cells following implantation, which potentially could positively affect the vascular access. The vessel has the potential to be stored onsite in a hospital – making it readily available for implementation.

National Early-phase Study in PAD

Dr. Belkin is the Principal Investigator for an NIH-supported national study of the vessel in patients with peripheral arterial disease (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). BWH is one of four sites in the United States that have been selected to participate in this prospective, open-label single-treatment-arm Phase II study to evaluate the safety and efficacy of the Human Acellular Vessel (HAV) in patients with peripheral arterial disease who are undergoing femoro-popliteal bypass surgery.

One of the primary objectives of the study will be to determine the patency of the HAV at 12 months post-implantation. Secondary objectives include further assessment of safety in terms of patient immune response and determination of the rates of HAV interventions required to keep the HAV patent. For more information, or to refer a patient for this trial, please contact Dr. Belkin at mbelkin@partners.org.

International Phase 3 Study in ESRD

BWH Vascular Surgeon C. Keith Ozaki, MD, is the Site Principal Investigator of an international randomized two-arm Phase III study comparing the new vessel with expanded polytetrafluoroethylene (ePTFE) grafts as conduits for hemodialysis in ESRD patients who are not candidates for fistula placement – An Assessment of Humacyte®’s Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison With ePTFE Grafts as Conduits for Hemodialysis (HUMANITY). Randomization occurs at the time of surgery and is stratified by upper arm or forearm placement based on the principal investigator’s clinical determination.

Each subject will be followed by study-specific visits until they complete 24 months of follow-up after implantation, regardless of patency status. After two years, only subjects with a patent conduit will be followed up to five years post-implantation at routine study visits. This study is ongoing and recruiting participants. For more information, or to refer a patient for this trial, please contact C. Keith Ozaki, MD, at ckozaki@partners.org.

“If the new vessel proves to be beneficial in patients with ESRD and PAD, it may be able to assist with vascular therapies in other areas as well, including the heart,” said Dr. Ozaki.

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To learn more or to refer a patient, please call our referral coordinators at (617) 732-9894.

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