09/02/2026 | Orlando Pontes | Brasília Capital

https://bsbcapital.com.br/anvisa-abre-debate-nacional-sobre-polilaminina/ 

Debate to include participation from the national scientific community

The National Health Surveillance Agency (Anvisa) will hold a panel discussion on Tuesday (the 8th) regarding the use of polilaminin in Brazil. The panel will be held online and is open to invitees from the scientific community, neurosurgeons, and medical societies, as well as the Federal Council of Medicine and the Ministry of Health.

The decision to launch a national discussion on the drug—produced by the laboratory Cristália based on a discovery by researcher Tatiana Sampaio, head of the Extracellular Biology Laboratory at the Institute of Biomedical Sciences of the Federal University of Rio de Janeiro (UFRJ)—stemmed from the widespread reaction to a video featuring a patient with tetraplegia.

Thiago Camargo, known as Tiba, suffered a spinal injury while attempting to rescue one of his six children who was drowning in a river. Upon diving in, he struck his head on a rock and was left paralyzed from the neck down. Accompanied by neurosurgeon Danilo Deriggi, he and his wife are calling on Anvisa to accelerate studies on polilaminin, which has the potential to cure people in his condition. The video has garnered over 12 million views.

An analysis of the treatment's efficacy is currently under review by Anvisa. Data presented by Cristália supported the authorization granted on January 5 of this year for the start of clinical research. To date, however, the study has not yet begun. The objective is to evaluate the safety of the investigational product in five patients aged 18 to 70 who have suffered a thoracic spinal cord injury (vertebrae T2 to T10) requiring surgery, with the investigational product administered within 72 hours of the trauma. However, the company has not yet initiated this clinical trial.

The compassionate use program applies to patients who were unable to enroll in the study authorized by Anvisa but meet the criteria outlined in the investigator's brochure and clinical protocol. Currently, however, this does not apply to other types of injuries. In other words, despite the growing number of requests for the use of polilaminin, there are no technical parameters in place to authorize the drug's use. To date, the approved study covers only individuals with thoracic injuries ranging from T2 to T12, yet there are requests for treatments involving the lumbar and cervical regions.