02/13/2026 | Ana Menezes | NSC Total

https://www.nsctotal.com.br/noticias/laboratorio-afirma-que-mortes-apos-uso-de-polilaminina-nao-tem-relacao-com-remedio 

There is no evidence that the deaths were caused by the application of the substance, says the Cristália laboratory.

Three patients who received polylaminin — an experimental drug developed at the Federal University of Rio de Janeiro (UFRJ) for the treatment of spinal cord injury — died this year after gaining access to the product through court orders. According to the Cristália laboratory, responsible for its manufacture, the patients presented serious clinical conditions. However, there is no evidence that the deaths were caused by the application of the substance. (Information from O Globo).

Polylaminin is still considered experimental. This means that it has not completed the three mandatory phases of clinical studies in humans, steps that attest to safety and efficacy. In early January, the Brazilian National Health Surveillance Agency (Anvisa) authorized the start of phase 1 of clinical trials, which will be conducted with only five volunteers and focuses primarily on evaluating the product's safety.

Despite not yet completing the regulatory process, the announcement of the development of polylaminin has led patients with spinal cord injuries to resort to the courts to obtain access to the treatment. With favorable rulings, the laboratory was obliged to provide and administer the substance in cases considered severe and without therapeutic alternatives. To date, Cristália reports having received 37 judicial requests, of which 22 resulted in the administration of the medication.

Although these applications are not part of the formal clinical study, the laboratory states that it monitors the cases through contact with the responsible physicians or family members, in order to monitor possible adverse events. The analysis seeks to establish whether there is a causal relationship between the use of polylaminin and any complications.

In a statement, the company declared: “Cristália Laboratory is aware of the three deaths that occurred on January 28, 2026, February 1, 2026, and February 9, 2026. Based on the information we have today, the deaths were due to pulmonary embolism, septic shock, and pneumonia with septic shock, respectively. The evaluation of the deaths, with the available information, indicates that none of them were related to polylaminin. Notification of the first two deaths has already been made to Anvisa (Brazilian Health Regulatory Agency), and notification of the third is currently being made.”

The company also emphasizes that the patients who filed lawsuits presented severe clinical conditions. According to medical literature cited by the laboratory, depending on the level of injury, care received, comorbidities, and other associated factors, the fatal outcome rate can reach up to 40% in some statistics.

In an interview with the newspaper O Globo, Tatiana Sampaio, head of the Extracellular Matrix Biology Laboratory at the Institute of Biomedical Sciences of UFRJ and responsible for the development of polylaminin, had already warned about the limitations of its use by court order. According to her, these applications do not follow the strict protocols of clinical research, which compromises adequate monitoring;

— We cannot monitor the people, provide the best support, or collect the data that Anvisa needs. We are using an experimental drug without the protection of a clinical study — she stated.

Clinical study to verify safety
In parallel with the so-called compassionate use, Anvisa authorized the start of phase 1 of the clinical study. This stage will involve five volunteers, aged between 18 and 72 years, who have suffered a complete injury to the thoracic spinal cord between vertebrae T2 and T10, with surgical indication, within 72 hours after the trauma. Patients with chronic injuries will not be able to participate.

The central objective of this initial phase is to evaluate the safety of polylaminin, identifying risks and possible side effects. If the results are considered satisfactory, the drug may advance to phases 2 and 3, designed to prove the treatment's efficacy. Only after the completion of all three stages can the product be submitted to Anvisa (Brazilian Health Regulatory Agency) for approval and eventual release for use.

The request to begin clinical studies in humans was submitted at the end of 2022. Since then, the regulatory agency's technical team has held meetings and provided guidance to the laboratory and researchers to adapt the documentation and meet all the requirements for clinical research in Brazil.

The submitted documentation was based on pre-clinical phase tests, conducted in the laboratory with animal models and also with human patients. These preliminary studies serve to indicate the therapeutic potential of the substance, but are not sufficient to prove efficacy or authorize its widespread use—which depends on clinical trials.

What is polylaminin?
The development of polylaminin began 27 years ago. The substance is produced from laminin, a protein isolated from placentas. Among its functions is the ability to stimulate the regeneration of axons — extensions of neurons that are damaged in spinal cord injuries and whose interruption compromises communication between the brain and muscles.

In preliminary tests, polylaminin was administered to dogs and a group of eight human volunteers, treated between 2018 and 2021 in the acute phase of the injury, up to 72 hours after the trauma. The application occurred directly into the spinal cord during surgery. The results were heterogeneous: some patients showed complete recovery of movement, while others registered partial improvement.

In the clinical study now authorized, an injectable formulation of laminin at a concentration of 100 μg/mL will be used, which must be diluted before application to form polylaminin. The process, known as polymerization, connects smaller molecules into a larger structure, increasing its potency. The medication will be administered as a single dose, intramedullary, directly into the injured area.