Medical Milestone: Israeli Spinal Cord Development Cleared for Human Trials
A dramatic breakthrough in the rehabilitation of the paralyzed: The US Food and Drug Administration (FDA) has approved the design of the first human clinical trial for Matriself. Here are the details on the revolutionary technology poised to transform medical treatment.
Matriself, a company developing engineered human neural tissue for the treatment of traumatic spinal cord injuries, reports a significant milestone: the company has received a written response from the CBER center of the US Food and Drug Administration (FDA) supporting the design of the first human clinical trial for the implantation of its flagship development, NewRal. As part of the response, the FDA expressed agreement with the key components of the plan presented by the company.
According to the outline approved in principle, the treatment is intended for adult patients suffering from a traumatic, chronic, and complete spinal cord injury in the thoracic region (between T2 and T12), defined as AIS A. This is an open-label, single-arm trial that will include a 12-month follow-up period and, in its first stage, will focus on examining the safety and tolerability of the treatment.
At the same time, the American agency also accepted the use of exploratory endpoints to examine initial signs of efficacy, including changes in neurological function, reduction of spasticity, and improvement in the level of functional independence of patients.
Alongside these important agreements, the FDA required Matriself to make several adjustments and completions before submitting the full IND (Investigational New Drug) application. Among other things, the company is required to establish precise rules for stopping the trial, criteria for discharging patients, and a more extensive breakdown of the surgical procedure and imaging criteria for patient matching.
"The feedback we received from the FDA constitutes another significant step in the company's progress toward the clinical stage. The fact that the FDA expressed agreement with key components in the design of the first human trial provides us with important regulatory guidance ahead of the IND submission and the continued advancement of the NewRal program to the clinic, alongside the adjustments and completions we were asked to perform," stated Gil Hakim, CEO of Matriself.
Just a few months ago, in June 2026, Matriself reported that it had begun conducting a comprehensive preclinical efficacy trial in an accepted model of spinal cord injuries, which was intended to support the preparation for this exact application. The company's technology, based on the research of Chief Scientist Prof. Tal Dvir, aims to produce biological "spare parts" and engineered tissues that may in the future change the lives of hundreds of thousands of paralyzed people around the world.
Furthermore, the company recently signed a memorandum of understanding with a private Israeli company currently in the process of being founded, with the goal of establishing a dedicated subsidiary to be called NeuroVectis. The new company, which will operate as a spin-off, will focus on the research, development, and commercialization of an innovative treatment for Parkinson's disease, which will be based on Matriself's core technology platform and will integrate advanced induced pluripotent stem cell (iPSC) technologies.
