Humacyte’s Human Acellular Vessel Studied for Limb Salvage in Multiple Complex Vascular Reconstruction Scenarios

January 31, 2022—Humacyte, Inc. announced results from the first series of compassionate-use cases of the company’s investigational human acellular vessel (HAV) for the treatment of critical limb ischemia and vascular trauma. Humacyte’s HAVs are engineered replacement vessels that are being designed to be durable, infection-resistant, and off-the-shelf to address long-standing limitations in vessel tissue repair and replacement.

Humacyte reported that the HAVs were observed to remain patent and infection free in patients requiring vascular reconstruction. These findings suggest the potential of the HAV to expand limb salvage options for patients who have exhausted current revascularization conduit options.

The series includes eight patients treated under the FDA’s Expanded Access Program (EAP). Under the EAP, Humacyte’s HAVs have been implanted in more than 20 patients to address multiple severe vascular repair, reconstruction, and replacement conditions when there is not a suitable conduit available for treatment, stated the company.

According to the company, each of the eight patients had severe peripheral arterial disease (PAD) or vascular injury requiring vascular reconstruction but lacked other treatment options and were at risk for limb loss.

In this high-risk group of patients, five of the bypasses performed with the HAV currently remain patent (with follow-up times ranging from 4 to 20 months after surgery), and no incidences of infection of the HAV were noted. Investigators treating these patients concluded that the HAV may greatly expand opportunities for limb salvage in trauma and urgent vascular reconstruction when patients lack suitable alternative conduits.

In addition to infection resistance and durable patency, the presentation highlighted the potential clinical utility of the HAV that can be implanted using normal surgical procedures as a readily available, biological alternative for patients at high risk for amputation.

The findings on these eight patients were presented by Alexander Kersey, MD, at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society (VESS). VESS was held January 27-30 in Snowmass, Colorado. The presentation, “Real World Experience with the Human Acellular Vessel: A Bioengineered Implant for Arterial Repair That Expands Limb Salvage Options,” is available on the company’s website, Humacyte.com.

Dr. Kersey, who is with the Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center in Bethesda, Maryland, commented in the company’s press release, “Many patients who require urgent vascular reconstruction due to vascular injury or severe peripheral arterial disease are not candidates for synthetic vascular grafts or autologous vein grafts, and those who’ve exhausted other treatment methods are at high risk of amputation. There is considerable need for a new treatment option to avoid resorting to amputation, and results from these compassionate use cases merit additional research into the role the HAV may play in the future of limb-sparing surgery.”

The HAV received the FDA’s Regenerative Medicine Advanced Therapy designation and the FDA Fast Track designation.

The HAV is currently being evaluated in late-stage clinical trials in vascular trauma repair, arteriovenous access for hemodialysis, and PAD. The HAV is an investigational product candidate and is not currently approved for sale by the FDA or any international regulatory authority, advised Humacyte.