01/05/2026  |  Jairo Marques  |  MSN by FolhaPress

https://www.msn.com/pt-br/saude/other/anvisa-libera-1%C2%AA-fase-para-pesquisa-cl%C3%ADnica-da-polilaminina-e-cinco-volunt%C3%A1rios-receber%C3%A3o-a-droga/ar-AA1TBBAy 

 After a process that took almost three years of analysis and requests for information and validation, Anvisa announced on Monday morning (5) the release of phase 1 clinical research on polylaminine, a substance that has been shown to regenerate spinal cord injuries, according to a group of researchers from UFRJ (Federal University of Rio de Janeiro), led by biologist Tatiana Coelho de Sampaio, during scientific tests.

From now on, the Cristália laboratory, a Brazilian company sponsoring the study, will select, monitor, and follow up on five volunteers who will receive the product. It has not yet been disclosed how and where people will be selected, but according to the pharmaceutical company, it will likely be in the states of Rio de Janeiro, São Paulo, and Espírito Santo.

If all three stages of analysis are completed, polylaminine, made from a protein extracted from the placenta, will begin to be produced industrially. Discussions are already underway between the company and the Ministry of Health so that, if approved, the product will be made available through the SUS (Unified Health System).

Only people between the ages of 18 and 72 who have been diagnosed with complete spinal cord injury, with total loss of sensation and movement, with paraplegia or quadriplegia, will be eligible to receive polylaminine during the clinical phase. At this time, the team is targeting only patients who have suffered trauma within a maximum of 72 hours, known as acute injury.

This analysis phase, which will last at least six months, aims to verify the safety of the application, which is made directly into the patient's spinal cord. Depending on the results of phase 1 of the study, the product may advance to phases 2 and 3, which aim to prove the efficacy of polylaminine.

“I am happy and relieved. Now we can move forward and get more answers. We have a very promising substance. I hope that, if all goes well, we can continue to show good results and that polylaminine can reach as many people as possible,” says Tatiana.

Last month, four people who suffered serious accidents with severe spinal cord injuries obtained court injunctions to receive the drug. Three of them, one from Espírito Santo, one from Rio de Janeiro, and one from Minas Gerais, underwent the procedure.

According to the research team, all are progressing well, with partial regained sensitivity in their lower limbs. Two of them, who underwent the procedure longer ago, are able to make small movements.

In cases of complete spinal cord injury, where there is total disruption of the spinal cord, documented cases of patient progress are rare.

The president of Anvisa, Leandro Safatle, who took office in September 2025, had already announced that polylaminine would be one of the agency's priorities for this year.

The drug safety assessment phase seeks to verify the risks to which patients are exposed, the adoption of measures to reduce them, and the feasibility of continuing with the study.

During preclinical trials, in the scientific field, no side effects were found in animals or in human volunteers. One of the patients at the time, Bruno Drummond de Freitas, 31, who had been diagnosed with quadriplegia by medical teams, regained movement after the application and extensive rehabilitation.