Israeli Spinal Cord Therapy Gets FDA Green Light for Human Trials
Israeli biotech company Matriceal announced a significant milestone as the U.S. Food and Drug Administration (FDA) provided written feedback supporting the design of its first human clinical trial for NewRal, an engineered human neural tissue designed to treat traumatic spinal cord injuries. The FDA agreed with key components of the company's proposed trial plan.
The proposed trial, which will be open-label and single-arm with a 12-month follow-up, will initially focus on the safety and tolerability of the NewRal implant. It is intended for adult patients with chronic, complete spinal cord injuries in the thoracic region (T2 to T12), classified as AIS A. The FDA also approved the use of exploratory endpoints to assess early signs of efficacy, including neurological function changes, spasticity reduction, and improved functional independence.
While expressing agreement on core aspects, the FDA requested Matriceal to make several adjustments before submitting a full Investigational New Drug (IND) application. These include defining precise trial cessation rules, patient release criteria, and providing more detailed information on the surgical procedure and patient imaging selection criteria.
Matriceal CEO Gil Hakim stated that the FDA's feedback is a crucial step toward the clinical stage, offering important regulatory guidance for the IND submission and further advancement of the NewRal program. He noted that the company had recently completed a comprehensive preclinical efficacy study in a spinal cord injury model to support this regulatory process.
The company's technology, based on research by Chief Scientist Prof. Tal Dvir, aims to create biological "spare parts" and engineered tissues that could potentially transform the lives of hundreds of thousands of paralyzed individuals globally. Matriceal also recently signed a memorandum of understanding to establish a joint venture, NeuroVectis, to develop and commercialize a Parkinson's disease treatment using its core technology and induced pluripotent stem cells (iPSCs).
