Anvisa restrictions on polylaminin use in Brazil

Brazil’s National Health Surveillance Agency (Anvisa) has implemented stricter regulations on the compassionate use of polylaminin, an experimental protein derived from human placenta intended for spinal cord injury regeneration.

The restrictions follow reports of patient deaths associated with the substance. While initial reports indicated nine deaths among 119 patients, subsequent investigations confirmed eight deaths occurring since January 2026. Anvisa determined that the substance was being administered outside of authorized technical parameters, specifically for cervical spinal injuries and for traumas occurring more than 72 hours after the initial injury.

Under the new regulations, access is limited to patients with complete spinal cord injuries occurring within the last 72 hours that specifically affect the thoracic region between vertebrae T2 and T10. The pharmaceutical company Cristália, which developed the substance in partnership with the Federal University of Rio de Janeiro (UFRJ), maintains that pharmacovigilance investigations found no causal link between the deaths and the treatment. Although a Phase 1 clinical trial was approved in January, the study has not yet commenced.