NASDAQ — Healthcare: Manufacturing, Biotechnology: Biological Products (No Disgnostic Substances)
www.humacyte.comHumacyte, Inc. is expected to complete its Phase 3 clinical trial (NCT03183245) comparing the Human Acellular Vessel (HAV) with fistulas as conduits for hemodialysis by September 1, 2025. The trial, which has an enrollment count of 240 participants, is currently active but not recruiting. Subjects in the study are randomized to receive either the HAV or traditional arteriovenous fistula (AVF), with follow-up periods extending up to 5 years post-creation, depending on device patency. This trial aims to evaluate the performance of HAV in a hemodialysis context, which may impact treatment choices and patients' healthcare outcomes.
Clinical Trial CompletionHumacyte, Inc. announced the expected completion of its Human Acellular Vessel (HAV) clinical trial for patients with vascular trauma on September 1, 2027. This multicenter, non-randomized phase 2 study involves up to 40 adult patients who require surgical repair for life- or limb-threatening vascular trauma. Participants will receive an HAV as an interposition vessel or bypass in surgical procedures. The trial, which began on September 1, 2018, has an overall status of active but not recruiting, with an anticipated total duration of 61 months for all participants. The findings may impact the company's therapeutic portfolio and market positioning in vascular repair solutions.
clinical trialHumacyte, Inc. is set to complete a Phase 3 clinical trial comparing the efficacy and safety of ATEV with AVF in female patients suffering from end-stage renal disease (ESRD) requiring hemodialysis. The trial, which has been recruiting since September 2023, aims to enroll approximately 150 patients who will be randomly assigned to either treatment arm. Expected trial completion is scheduled for October 1, 2027. Following the initial 12 months of results, patients with a patent surgical access will continue in a Long-Term Extension study to assess exploratory long-term endpoints. The results could have significant implications for the treatment approaches to ESRD.
clinical trial completion