Announcement • Jun 25
Matricelf Initiates Ind Enabling Efficacy Study for Engineered Human Neural Tissue Implant in Chronic Spinal Cord Injury Matricelf Ltd. announced the initiation of a pivotal preclinical efficacy study evaluating its engineered human neural tissue implant for the treatment of chronic spinal cord injury. The study is designed to generate efficacy data supporting the Company's preparations for a first in human clinical trial. The study is being conducted in accordance with a development framework previously discussed with the U.S. Food and Drug Administration (FDA) and is intended to serve as an IND enabling efficacy study. The program will evaluate functional, behavioral, and histological endpoints that are widely accepted as key measures of therapeutic efficacy in spinal cord injury research. The newly initiated study builds upon previously reported preclinical results demonstrating significant improvements in motor function, sensory recovery, and tissue regeneration following implantation of Matricelf's engineered neural tissue in spinal cord injury models. The current study is designed to further validate the therapeutic potential of the technology using a comprehensive efficacy framework intended to support future regulatory submissions and clinical development. The study will include 96 animals with chronic spinal cord injury and will assess motor and sensory recovery using established outcome measures, including BBB, CatWalk, Mechanical Allodynia, and Thermal Allodynia testing, alongside comprehensive histological analyses of tissue repair and regeneration at the injury site. The study is expected to continue for approximately 12 weeks. Matricelf anticipates receiving interim results during the Fourth Quarter of 2026 and final study results during the First Quarter of 2027. Matricelf is developing a personalized neural tissue implant designed to treat patients suffering from paralysis following spinal cord injury. The Company's technology combines patient derived cells and biomaterials to create an autologous engineered implant tailored to each individual patient. Subject to successful study outcomes, completion of ongoing development activities, regulatory approvals, and financing requirements, Matricelf plans to seek authorization to initiate its first clinical trial in humans. Announcement • Jun 17
Matricelf Completes GLP Safety Study for Engineered Neural Tissue Implant Matricelf Ltd. announced the successful completion of its comprehensive GLP safety study for its engineered neural tissue implant, achieving all predefined study endpoints with no abnormal findings. The study evaluated key safety parameters including toxicology, tumorigenicity, and biodistribution in 248 animals monitored for up to 39 weeks following implantation. Results demonstrated no treatment related toxicity, no evidence of tumor formation, and no migration of the implant to distant organs or tissues, supporting the safety profile of the Company's lead therapeutic program. The GLP study was designed as an IND enabling safety program and represents a significant milestone in Matricelf's preparations for a first in human clinical trial. The successful completion of the study provides an important component of the Company's future regulatory submissions and advances its clinical development roadmap. Matricelf is developing a personalized neural tissue implant designed to treat patients suffering from paralysis following spinal cord injury. The Company's technology combines patient derived cells and biomaterials to create an autologous engineered implant tailored to each individual patient. Subject to successful completion of ongoing preclinical studies, regulatory approvals, and financing requirements, Matricelf plans to seek authorization to initiate its first clinical trial in humans. Announcement • Mar 05
Matricelf Ltd. Reports Positive RNA Sequencing Results Demonstrating Promising Safety Profile Of Its Personalized Spinal Cord Implant Matricelf Ltd. announced positive results from advanced RNA sequencing analyses of its human tissue implant, supporting key safety characteristics required for progression toward clinical trials. The analyses were conducted as part of a comprehensive safety characterization program aligned with international regulatory standards, including requirements of the US FDA. Matricelf performed advanced genetic testing using single nucleus RNA sequencing technology seq snRNA on 4 separate implant batches to enable deep characterization of the cellular composition of its proprietary engineered neural tissue implant. The findings support that all cell populations within the implant are in a post mitotic state, meaning there was no evidence of proliferative or dividing cells. The results indicate normal developmental progression of the engineered tissue and demonstrate that the cells have reached a stable stage of differentiation without continued cell division. Importantly, the absence of proliferating cells significantly reduces potential risks such as uncontrolled cell growth or formation of unintended tissue, key considerations in the development of advanced cell based therapies. Matricelf is developing an autologous engineered neural tissue implant for patients suffering from paralysis due to spinal cord injury. The implant consists of both cellular and extracellular components derived from the patient's own body. The cellular component is generated from a blood sample collected from the patient, from which induced pluripotent stem cells iPSCs are produced. In parallel, an omentum tissue sample, a fatty tissue surrounding abdominal organs, is harvested to create a proprietary hydrogel serving as the extracellular scaffold. Using Matricelf's proprietary tissue engineering process, the cellular and extracellular components are combined to create a personalized engineered neural tissue implant intended to repair the patient's injured spinal cord. The positive RNA sequencing results represent an important milestone in the company's regulatory and clinical development pathway as it prepares for advanced preclinical studies and future human clinical trials. 
