Overview
- Anvisa now allows polilaminina on compassionate grounds only for patients who match the phase‑1 trial entry rules: acute spinal injuries within 72 hours located between vertebrae T2 and T10.
- The decision follows reports of nine deaths among roughly 119 compassionate‑use applications and a September technical panel of neurologists and Conselho Federal de Medicina experts that unanimously advised against expanding access.
- Cristália, the manufacturer, says its pharmacovigilance investigations found no causal link between the deaths and polilaminina and has defended the data it submitted to the regulator.
- UFRJ researcher Tatiana Sampaio criticized the restriction as illegal and has called for broader access including patients with complete and cervical‑level injuries, a stance that escalates tensions between the developer, regulator, company, and patient advocates.
- Polilaminina remains in a phase‑1 safety trial with no patients enrolled because eligible candidates have not been recruited, leaving uncertainty over how safety and effectiveness will be established before any wider access is considered.