Anvisa restricts polylaminin use following eight patient deaths

Brazil’s National Health Surveillance Agency (Anvisa) has tightened regulations and restricted new patients from compassionate use programs involving polylaminin. The decision follows the confirmed deaths of eight patients since January 2026.

Investigations revealed that the biological substance, intended for spinal cord injury regeneration, was being administered outside of authorized technical parameters. Specifically, the protein was being used for cervical spinal injuries and for traumas occurring more than 72 hours after the initial injury, both of which fall outside the approved criteria. Anvisa noted that the responsible laboratory, Cristália, failed to provide scientific evidence to support these atypical applications.

Polylaminin is a protein derived from human placenta, developed through a partnership between Cristália and the Federal University of Rio de Janeiro (UFRJ). While it is under investigation in a Phase 1 clinical study, the agency determined that the risk-benefit ratio necessitated stricter controls to prevent further deaths resulting from improper application.