Receiving FDA Feedback Supporting Key Elements of Matricelf’s Proposed First-in-Human Clinical Trial
Matricelf announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) supporting key elements of the proposed first-in-human clinical trial for NewRal, the Company’s investigational personalized autologous neural tissue transplant.
The FDA expressed agreement with the proposed patient population. Adults with chronic, complete traumatic thoracic spinal cord injuries (AIS A, T2–T12) and an open-label, single-arm trial design with an initial 12-month follow-up period, primarily focused on safety and tolerability.
The feedback also supported the proposed primary safety assessments and exploratory efficacy measures evaluating neurological changes, spasticity and functional independence. It provides regulatory guidance as Matricelf prepares for a future Investigational New Drug (IND) submission, including requested additions regarding trial stopping rules, patient discharge criteria, surgical procedures and imaging criteria for patient selection.
The feedback was based on a limited clinical trial synopsis and does not constitute review or clearance of a complete IND application or authorization to initiate a clinical trial. NewRal remains investigational and has not yet been evaluated in humans. Matricelf will incorporate the FDA’s comments as it continues preparations toward clinical development.

