Hemostemix Adds the Treatment of Refractory Angina to Its Phase 1 Basket Protocol

Core Viewpoint - Hemostemix Inc. has completed the drafting of a clinical trial protocol for the treatment of refractory angina using its ACP-01 stem cell therapy, aiming to provide new options for patients who do not respond to standard treatments [1][3][15] Company Overview - Hemostemix Inc. is a leading autologous stem cell therapy company that offers VesCell™ (ACP-01) for various conditions including angina and chronic limb threatening ischemia [1][15] - The company has a history of over two decades in developing and scaling autologous blood-based stem cell therapies and has completed seven clinical studies involving 318 subjects [15][16] Clinical Trial Details - The Phase 1 clinical trial will enroll 20 to 100 adults aged 40–90 years with recurrent or refractory severe angina, focusing on feasibility and safety as primary endpoints [9][10] - ACP-01 will be administered via intracoronary injection, with secondary endpoints including improvement in chest pain frequency, quality of life, and left-ventricular ejection fraction (LVEF) [9][10] Scientific Rationale - ACP-01 cells are derived from the patient's own blood and are designed to promote new blood vessel formation and micro-circulatory repair, potentially improving heart function [6][7] - Previous studies indicated that patients receiving ACP-01 therapy experienced improved heart function and reduced emergency treatment needs [8][6] Mechanism of Delivery - The delivery of ACP-01 will be performed through an intracoronary route under fluoroscopic guidance, allowing precise localization to ischemic areas [11][12] - The procedure is expected to be safe and feasible in outpatient settings, with no reported serious complications in prior trials [11][14] Safety Oversight - The clinical trial will be monitored by qualified interventional cardiologists and a Data Safety Monitoring Board (DSMB) to ensure patient safety during the procedure [13][14]