Anvisa Authorizes First Safety Trial of Experimental Polilaminin for Acute Spinal Cord Injury

Overview

• The phase‑1 study is slated to begin in March and will enroll five adults with complete thoracic T2–T10 injuries treated within 72 hours, with six months of safety follow‑up.
• An earlier academic series of eight patients reported motor improvements in six, including one exceptional recovery, but the data lack controls and peer review and cannot establish causality.
• Outside the trial, Cristália reports 57 compassionate‑use requests and 28 applications performed, which do not demonstrate safety or efficacy; the regulator has been issuing authorizations in one to two days.
• The candidate is a placenta‑derived polymerized laminin delivered as a single intramedullary application during indicated surgery, and current protocols exclude chronic injuries.
• Cristália states its 2022–2023 patents protect the manufacturing process in Brazil and internationally through 2042–2043, while earlier UFRJ international filings lapsed, a history that remains contested.