Humacyte, Inc. Announces Data from A Phase 2 Clinical Trial of Human Acellular Vessel
November 15, 2021 at 05:10 pm EST
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Humacyte, Inc. announced that data from a Phase 2 clinical trial of patients receiving the human acellular vessel (HAV) produced using its cutting-edge, large-scale manufacturing systems, known as ?LUNA200?, for vascular access in hemodialysis, demonstrated 12-month efficacy that is similar to trials of HAVs produced in the development-scale systems previously used in manufacturing the HAV. The Phase 2, prospective, multicenter, open-label, single-arm study evaluated the safety, efficacy and immunogenicity of HAVs manufactured with the commercial-scale LUNA200 platform in 30 end-stage renal disease patients undergoing hemodialysis. One year after implantation, 83% of subjects still showed secondary, or functional, patency. Secondary patency rates of the HAVs produced using the prior, development-scale systems ranged from 82% to 89%. No instances of HAV rupture, aneurysm formation or acute mechanical failure were observed in the study. In addition, the HAV appears to resist infection as compared to synthetic conduits. Each modular, automated LUNA200 system, with enhanced process controls, can grow 200 HAVs at a time. Humacyte?s LUNA200 systems are housed in its 83,000-square-foot bioprocessing facility in Durham, N.C., which has ample space to house enough systems to produce an annual capacity of approximately 40,000 HAVs per year. The Durham facility is fully operational, and in 2021 the FDA authorized the use of HAVs produced in the LUNA200 system to supply the Company?s ongoing clinical trials in the United States. The facility also achieved compliance with EU good manufacturing practices (GMP) and Qualified Person Certification to allow product to be supplied to ongoing studies in Europe and Israel. The 12-month data were presented at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS2021). The secondary objective of this study is to evaluate the long-term safety and efficacy of the HAV manufactured with the LUNA system for up to 36 months after implantation, and the study is ongoing.
Humacyte, Inc. is engaged in the development and manufacturing of off-the-shelf, universally implantable, bioengineered human tissues. The Company is engaged in developing a portfolio of human acellular vessels (HAVs) with varying diameters and lengths. The HAV cabinet would initially target the vascular repair, reconstruction, and replacement market, including vascular trauma; atrioventricular (AV) access for hemodialysis; peripheral arterial disease (PAD); and coronary artery bypass grafting (CABG). The Company has developed a novel paradigm for manufacturing human tissues that are intended to mimic key aspects of human physiology. It is also engaged in developing its HAVs for pediatric heart surgery and the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes. The Companyâs scientific technology platform uses primary human aortic vascular cells from a working cell stock, isolated from donor tissues and cryopreserved.
HUMACYTE, INC. 
