Compassionate Use Request Submitted for Spinal Cord Injury Treatment Following successful outcomes in preclinical studies, Matricelf has submitted a preliminary request to the Ministry of Health (Pharmaceutical Division) for approval to use its engineered neural tissue implants in a compassionate use treatment for a patient with traumatic spinal cord injury. This request, initiated in collaboration with Sheba Medical Center (Tel Hashomer), aims to offer a potential treatment option for patients with significant disabilities. The proposed treatment utilizes autologous tissue derived from the patient’s own cells, providing a unique and highly personalized approach to regenerative medicine.
Commenting on this request, Professor Ran Harel, Director of the Spinal Surgery Unit at Sheba Medical Center, expressed his support for the technology, stating, "Matricelf's breakthrough technology holds great promise for improving the quality of life for patients with severe spinal cord injuries who currently have limited medical options."
Matricelf's CEO, Gil Hakim, added, "This collaboration is a vital step in advancing our innovative treatment towards real-world clinical applications. We are committed to meeting the rigorous standards required by the Ministry of Health and other regulatory bodies to make this treatment accessible to those in need."
Success in Preclinical Efficacy Trial of Spinal Cord Implants In addition to the compassionate use request, Matricelf is excited to announce the successful final results from its preclinical efficacy trial in rats, completed on October 10, 2024. The trial demonstrated significant improvements in motor function in treated animals, based on assessments using the FDA-recognized Basso, Beattie, and Bresnahan (BBB) scale and the advanced CatWalk XT system.
Key results include:
- An average improvement from a BBB score of 2.5 post-injury to 9.1 after 12 weeks in the treatment group, compared to 8.5 in the control group.
- 80% of treated rats showed statistically significant motor function improvements, with several achieving scores in the highest BBB category, indicating synchronized walking.
- The CatWalk XT system also revealed significant improvements in step synchronization, swing time, and forelimb step length in treated rats compared to the untreated group.
Dr. Tamar Harel-Adar, Matricelf's VP of R&D, remarked, "These results showcase the immense potential of our technology in restoring motor function for spinal cord injury patients. The improvement in movement and coordination is a testament to the robustness of our approach."
CEO Gil Hakim emphasized, "This milestone marks a major achievement for our company. The successful animal trial positions us to move forward with clinical applications, including our compassionate use program, as we continue to work towards offering a transformative treatment for spinal cord injury patients."
About Matricelf Ltd.
Matricelf is a biotech company in the field of regenerative medicine and tissue engineering, focusing on the production of autologous neural tissue transplants designed for treating spinal cord injury patients. The company is developing technology that enables the production of human tissue derived from cells taken from the patient (autologous implant). The technology being developed by the company can serve as a platform for other medical applications in the field of tissue engineering. The implants are autologous (self-derived) tissue aimed at restoring function of damaged tissues using cellular and extracellular components from the patient, therefore not triggering immune response.
The preparation of the implants is performed using proprietary technology that combines a hydrogel produced through a unique process involving the processing of an omentum piece (intra-abdominal fat tissue) taken from the patient, together with mature blood cells also sourced from the patient. The company's innovative technology is based on full autologous tissue engineering. As part of the process, the blood cells undergo a process of transformation into induced pluripotent stem cells (iPSCs). The uniqueness of these stem
cells rest in their self-renewal capability and their potential to differentiate into all cell types in the body. These cells are integrated with the hydrogel, and under a controlled protocol, are differentiated into functional neural tissue.
