Seven deaths linked to experimental polylaminina treatment in Brazil

Since February, seven patients who received the experimental protein polylaminina under a compassionate‑use program in Brazil have died. The drug, developed by Laboratório Cristália, is intended to promote nerve‑cell regeneration after spinal‑cord injury and is derived from a protein found in human placenta.

Cristália says the fatalities are unrelated to the substance, attributing them to other causes. More than 100 patients have been treated with polylaminina outside formal clinical trials; ten showed improvements in sensory or motor function, but none regained full walking ability. The Brazilian health regulator Anvisa approved 110 of 128 requests for compassionate use and recently shortened the permissible application window from 90 to three days after injury. The treatment has not yet entered a formal clinical trial at the Hospital das Clínicas of USP.

The most recent death was reported on 6 August, and the case was highlighted by researcher Tatiana Sampaio during a presentation at Rio Innovation Week.