Core Insights - NLS Pharmaceutics Ltd. and Kadimastem Ltd. announced the continuation of the ITOL-102 cell therapy program for Type 1 Diabetes under the merged entity NewCelX Ltd. following their merger [1][3][4] Group 1: Company Overview - NLS Pharmaceutics is a biopharmaceutical company focused on innovative therapies for central nervous system disorders [5] - Kadimastem is a clinical-stage cell therapy company developing treatments for neurodegenerative diseases and diabetes [6] Group 2: ITOL-102 Program - The ITOL-102 program aims to develop a functional, stem-cell-derived pancreatic islet cell therapy to cure Type 1 Diabetes without lifelong immunosuppression [3] - The BIRD Foundation, which has invested over $300 million in joint projects since 1977, will continue to support the ITOL-102 program under NewCelX [2][4] Group 3: Strategic Focus - The merger allows NLS to leverage Kadimastem's advanced stem-cell platform, expanding its pipeline into regenerative and metabolic medicine [4]

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]

Core Insights - Hemostemix has filed for ethics approval for a Phase 1 clinical trial of its stem-cell therapy, ACP-01, aimed at treating vascular dementia, a condition with no current cure [1][2][3] Industry Context - Vascular dementia (VaD) and vascular cognitive impairment (VCID) are the second most common causes of dementia globally, accounting for up to 20% of all dementia cases, highlighting a significant unmet medical need [3][4] - There are currently no FDA-approved therapies for VCID, positioning Hemostemix's trial as a pioneering effort in regenerative neuroscience [3] Company Overview - Hemostemix is advancing its autologous stem cell therapy platform, having previously demonstrated the safety and efficacy of ACP-01 in other conditions such as refractory angina and ischemic cardiomyopathy [5][26] - The company has completed seven clinical studies involving 318 subjects, with published results in eleven peer-reviewed journals, establishing a strong foundation for its current research [26] Clinical Trial Details - The Phase 1 study will evaluate the safety, feasibility, and preliminary efficacy of intrathecal administration of ACP-01 in patients aged 50 and older diagnosed with vascular cognitive impairment or vascular dementia [7][11] - The trial will include 20 to 100 participants, with a follow-up period of one year to monitor safety and cognitive improvements [16][11] Mechanism of Action - ACP-01 cells are derived from the patient's own blood and are designed to restore brain perfusion and neurovascular integrity by leveraging the body's natural signaling processes [20][21] - The direct intrathecal delivery method allows for better penetration to the brain, potentially enhancing the therapeutic effects compared to previous intravenous methods [21][22] Safety and Oversight - The clinical procedures will be conducted in an outpatient setting under the supervision of licensed neurosurgeons, with comprehensive safety monitoring by an independent Data Safety Monitoring Board [23][24] Executive Commentary - The President & CEO of Hemostemix emphasized that this filing represents a significant advancement in applying ACP-01's regenerative capabilities to address vascular dementia, a challenging medical condition [25]