BRAZIL · HEALTH
Key Facts
- —The country Brazil, Latin America’s largest country, licenses medicines and approves clinical trials through Anvisa, its federal health surveillance agency.
- —Why it matters Polilaminina is an experimental spinal cord injury drug that patients, families and politicians pressed Brazil to release, so limits on it set a precedent for unapproved therapies.
- —Why now Anvisa announced the narrowing of compassionate use on Thursday 22 October 2026 after nine deaths among patients treated outside the trial and an unprecedented rise in access requests.
- —What happened Access is now limited to patients with injuries of up to 72 hours between vertebrae T2 and T10, the same criteria as the phase 1 trial approved in January 2026.
- —The numbers Nine deaths among 119 compassionate-use administrations, five of them notified between January and March 2026, and no patient yet treated inside the phase 1 trial.
- —What it means for you Polilaminina is an unapproved experimental drug whose safety and efficacy are unproven, so US readers should treat online claims of a cure with caution.
- —Still open Whether the deaths were linked to the drug, how many permits were court-ordered, and when the first trial patient will be treated.
- —Power Index Brazil ranks 1st of 14 in The Rio Times Latin America Power Index, with 75.0 points (October 2026 edition).
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Brazil’s health regulator Anvisa restricted compassionate use of the experimental spinal cord drug polilaminina, as it announced on Thursday 22 October 2026, after nine patients who received it outside the clinical trial died. The manufacturer says none of the deaths was related to the drug, while Anvisa says reliable safety data are missing.
For US readers the case tests how far a regulator should open access to an unapproved therapy when patients and families press for hope. Brazil’s answer was to narrow access to the same strict conditions as its first human trial.
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Polilaminina is not a food supplement but an experimental drug candidate for spinal cord injury, developed at the Federal University of Rio de Janeiro (UFRJ) and made by the pharmaceutical company Cristália. Our guide Brazil Education and Healthcare Explained describes the health system in which Anvisa works.
What Anvisa Decided on Polilaminina
From now on, compassionate use of polilaminina follows the same criteria as the phase 1 trial that Anvisa approved in January 2026. Only patients with acute spinal cord injuries of up to 72 hours, located between vertebrae T2 and T10 in the chest region, qualify.
Compassionate use is an exceptional release of a product still in development, for patients with serious conditions and no satisfactory alternative. Anvisa says its rules for it have been in force since 2013, follow international reference authorities and have not changed.
Tribuna Online reports that earlier permits covered complete injuries anywhere in the cord if the trauma was up to three months old. The lead researcher, Tatiana Coelho de Sampaio, says that was the practice until April.
Anvisa says earlier permits outside the trial design were granted before the study was approved or to obey court orders. The sources reviewed give no number for the court-ordered cases.
Anvisa also says it has received no request to study cervical (neck) injuries, the group that Sampaio wants included. Her goal is access for patients with complete injuries at any level, including tetraplegics, according to Exame and Folha de Pernambuco.
Nine Deaths and 119 Administrations
Exame and Folha de Pernambuco report that nine patients died among 119 compassionate-use administrations of the drug. Cristália notified five of those deaths between January and March 2026, and four more were notified later.
Cristália says its pharmacovigilance team investigated each case and found that none was related to polilaminina. The company told UOL that 111 patients with complete spinal cord injuries have received the drug through compassionate use, free of charge.
Anvisa says patients treated this way are not followed by the company or the researcher, so reliable safety data are missing. It also describes an unprecedented rise in requests, a situation it says it has never seen for any other investigational product.
In September Anvisa convened a panel with representatives of the Federal Council of Medicine, the regulator of the medical profession, and neurologists and neurosurgeons. The experts unanimously advised against expanding compassionate use and raised concerns about the deaths, the route of administration and safety.
Exame and Folha de Pernambuco note that broad expanded-access programmes normally require a product to be in phase 3. Polilaminina is in phase 1, the stage that mainly tests safety.
What Polilaminina Is and Where the Trial Stands
Polilaminina is a laboratory-made form of laminin, a protein found in the human body, studied for more than two decades at UFRJ for its potential to help damaged nerve fibres regrow. Exame reports that current production uses material from the placentas of healthy women giving birth, processed at a Cristália plant in Itapira.
Anvisa approved the phase 1 safety trial in January 2026, and on Wednesday 16 September Cristália said it would begin on 24 September with five patients. Veja reported that the sites are the Hospital das Clínicas of the University of São Paulo medical school and the Santa Casa de Misericórdia in São Paulo, with patients followed for six months.
As of 22 October no patient has received polilaminina under the trial protocol, according to Anvisa and Folha de Pernambuco. Cristália says it has not yet found a patient who meets the criteria and is waiting for one.
The design calls for patients aged 18 to 72 with complete acute thoracic injuries between T2 and T10 that need surgery and occurred less than 72 hours earlier. The Hospital das Clínicas said in September that such strict rules mean a gap is expected before the first eligible patient is found.
The Dispute Between Anvisa and the Lead Researcher
Sampaio, a UFRJ professor, criticised the restrictions in a social-media video and called them illegal, according to Tribuna Online. She argues that compassionate use is a legal right and that the new limits go against it.
Anvisa answered in a clarification note on 22 October that rejects personal attacks on its staff and board members. It said the review of the trial request took three years because key primary data arrived only in January 2026.
Anvisa also said the phase 1 study had not started ten months after approval, although the company had blamed the agency for delays. Terra reports Sampaio’s claim that the agency’s stance changed after an April meeting with the manufacturer, and the sources reviewed carry no Anvisa reply to it.
Cristália said it has full confidence in Anvisa and supports its board and technical staff. The company also said it does not plan to change the trial design based on compassionate-use data, which it says cannot serve as regulatory evidence.
What It Means for US Readers
The case matters most to readers who follow spinal cord research, biotech and drug regulation. Anvisa’s stated reasoning is that safety evidence has to come before wider access to an unproven therapy.
Polilaminina is not a product to buy, because it is an unapproved experimental drug that Cristália says it supplies free of charge under compassionate use. None of the sources reviewed describes a route for foreign patients or a trial in the United States.
Readers who meet online claims of a miracle cure should note that Anvisa says the data do not yet prove safety and efficacy outside the authorised conditions, according to Terra. Our São Paulo City Guide for Expats and Visitors covers life in the city where the trial sites are, and in a separate action Anvisa banned two Amazon listings, as we covered in Brazil Bans 2 Accu-Chek Amazon Listings.
What Is Not Known
The sources reviewed give no resolution number, official gazette date or effective date for the new compassionate-use rule. They also do not say how many of the 119 administrations were court-ordered, or why Anvisa’s figure of 119 differs from the 111 treated patients Cristália counts.
No cause of death has been published for any of the nine patients, and the company’s finding of no link has not been independently verified. It is also unknown when the first trial patient will be enrolled.
It is not known whether the restrictions will be challenged in court, as Sampaio calls them illegal, or whether Anvisa will revisit them as more safety data arrive. The English spelling of the drug in some outlets is polylaminin, but no source reviewed reports an approval for it anywhere.
Frequently Asked Questions
What is polilaminina?
Polilaminina is an experimental drug candidate for spinal cord injury, developed at UFRJ and made by Cristália. It is not a supplement and is not approved in Brazil.
What did Anvisa decide on 22 October?
Anvisa limited compassionate use to the criteria of the phase 1 trial, meaning acute injuries of up to 72 hours between vertebrae T2 and T10. It acted after nine deaths and a surge in access requests.
Did polilaminina cause the nine deaths?
That is not established, because Cristália says its investigation found no link and Anvisa says reliable safety data are missing. Patients treated under compassionate use are not followed by the company or the researcher.
Has the polilaminina clinical trial started?
Anvisa approved the phase 1 trial in January 2026, but as of 22 October no patient has been treated under its protocol. Cristália says it is waiting for an eligible patient.
Can US patients get polilaminina?
None of the sources reviewed describes access for foreign patients or a trial in the United States. The drug is unapproved, and compassionate use in Brazil is now restricted to trial-like conditions.
Sources: Anvisa, clarification note, 22 October 2026; Exame, 22 October 2026; Folha de Pernambuco, 22 October 2026; Terra, 23 October 2026; Tribuna Online, 23 October 2026; UOL, 22 October 2026; Veja, 16 September 2026.
This article was drafted with automated assistance and reviewed before publication. How we use AI · Report an error · Editorial responsibility: Matthias Camenzind, Editor-in-Chief
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