Matricelf Cleared to Advance NewRal Spinal Cord Treatment Toward Trials

The FDA’s written response confirmed that the company's proposed patient population—adults with chronic, complete traumatic thoracic injuries—aligns with regulatory expectations for an initial study. Officials also validated the use of a single-arm, open-label trial structure, noting that a 12-month follow-up period serves as a practical baseline for assessing human safety and tolerability.

While the agency green-lit the inclusion of exploratory efficacy measures like ISNCSCI, MAS, and SCIM III, it reminded the company that the primary focus remains on safety rather than therapeutic outcomes. Matricelf must now refine its Investigational New Drug (IND) package by detailing surgical procedures, imaging criteria, and specific trial-stopping rules to address the agency's remaining requirements. CEO Gil Hakim stated that the guidance marks a critical transition for the program as the firm prepares to move its autologous engineered tissue technology from the laboratory toward clinical practice.