Ness Ziona, Israel, September 3, 2026
Matricelf Ltd., a regenerative medicine company developing personalized engineered tissue therapies, has received written feedback from the U.S. Food and Drug Administration (FDA) on key elements of its proposed first-in-human clinical trial for NewRal, an investigational personalized neural tissue transplant being developed for patients with traumatic spinal cord injury. The feedback was provided by the FDA’s Center for Biologics Evaluation and Research (CBER) through a Written Response Only (WRO) interaction based on a limited clinical trial synopsis submitted by the company. The agency expressed agreement with several important components of the proposed study, providing regulatory guidance as Matricelf prepares for a potential future Investigational New Drug (IND) submission.
FDA Supports Proposed NewRal Trial Framework
According to Matricelf, the FDA expressed agreement with the proposed patient population, clinical trial design, and initial safety and exploratory efficacy assessments. The planned study would enroll adult patients with chronic, complete traumatic thoracic spinal cord injury classified as AIS A, a population characterized by severe neurological impairment following spinal cord trauma. The proposed first-in-human investigation is designed as an open-label, single-arm clinical trial with an initial 12-month follow-up period. The FDA considered this structure reasonable for an initial evaluation of NewRal’s safety and tolerability in humans, while the exploratory efficacy measures would provide early information about potential neurological and functional changes. The proposed clinical assessments include the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), Modified Ashworth Scale (MAS) and Spinal Cord Independence Measure III (SCIM III). These measures are intended to evaluate areas including neurological function, spasticity and functional independence. However, Matricelf emphasized that the proposed early-stage study is primarily focused on safety and tolerability, with the efficacy-related assessments considered exploratory rather than definitive evidence of therapeutic effectiveness.
NewRal Uses Personalized Engineered Neural Tissue
NewRal is being developed as an autologous engineered neural tissue transplant intended to repair damaged neural tissue following spinal cord injury. Matricelf’s platform combines patient-derived cellular components, including induced pluripotent stem cells, with a biomaterial scaffold derived from the patient’s own tissue. The personalized approach is designed to generate an engineered neural tissue construct that can potentially be used in repairing severe spinal cord damage. The technology originates from research conducted at Tel Aviv University and represents a regenerative medicine strategy distinct from conventional pharmacological approaches. The company’s latest regulatory interaction follows earlier development activities aimed at preparing NewRal for clinical testing. However, the therapy has not yet been evaluated in humans and remains investigational. Matricelf states that NewRal has not been approved by the FDA or any other regulatory authority, meaning the current regulatory milestone should not be interpreted as evidence of clinical efficacy or regulatory authorization for treatment.
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FDA Requests Additional Information Before IND Review
Alongside its support for key trial elements, the FDA requested that Matricelf address several additional matters in a future IND submission. These include trial stopping rules, objective criteria for patient discharge, additional details regarding the proposed surgical procedure and imaging criteria for patient selection. Matricelf plans to incorporate the regulatory comments as it continues preparing its IND package and advancing NewRal toward potential clinical development. The distinction between regulatory feedback and authorization is important. The FDA’s response was based on a limited clinical trial synopsis, rather than a complete IND application, and does not constitute IND clearance or authorization to initiate the proposed clinical trial. A future IND submission would remain subject to FDA review, and additional requirements or changes could be requested. Nevertheless, the feedback provides Matricelf with clearer regulatory direction for designing its first-in-human study and represents a significant step in the development of personalized regenerative medicine for spinal cord injury.
Source: Matricelf press release
