Portuguese 
The first regulatory phase of polylaminin begins on September 24 at the Hospital das Clínicas and Santa Casa de São Paulo, with five volunteers who suffered complete traumatic spinal cord injuries; the study will observe adverse effects and safety for six months, while efficacy will be evaluated in later phases with larger groups.
Polylaminin, a substance developed from Brazilian research that began more than two decades ago, is entering a crucial stage of its clinical development. Starting on September 24, 2026, five patients aged between 18 and 72 will participate in the first phase 1 regulatory clinical trial, conducted at two hospitals in São Paulo.
According to a report from Só Notícia Boa, published on September 16, 2026, the study announced by Laboratório Cristália will be conducted at the Hospital das Clínicas and the Santa Casa da Misericórdia. The main objective of this first phase is to assess the safety of the application, while broader efficacy investigation will be reserved for later stages.
Five patients will form the first group of the regulatory phase
Phase 1 has been designed with a limited number of participants because the initial focus is on observing how the body reacts to the substance. Researchers will monitor possible adverse effects and other signs to establish the safety profile of polylaminin.
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Volunteers must meet very specific medical criteria. The age range is set from 18 to 72 years, and all participants must have a complete spinal cord injury in the thoracic region, which significantly restricts the number of individuals eligible for this first phase.
Injury must be between the T2 and T10 vertebrae and have occurred less than 72 hours ago
The protocol stipulates that the traumatic injury must be located between the T2 and T10 vertebrae. Furthermore, the trauma must have occurred less than 72 hours ago, creating a narrow window for identifying and evaluating potential participants.
Another requirement is the indication for spinal decompression surgery, a procedure that would already be part of these patients’ medical treatment. Selection will be carried out by teams at both the Hospital das Clínicas and Santa Casa, with no open internet registration system.
Samu will assist in identifying potential participants
Since the time between trauma and study inclusion is short, Cristália reported that it is collaborating with the Mobile Emergency Care Service, known as Samu, to facilitate the referral of potential participants to the research centers.
Speed is necessary because the criteria require that the injury occurred less than three days before the evaluation. This means that identification must happen during the early stages of hospital care.
Application will occur only once during surgery
The polylaminin will be applied directly to the injured area of the spinal cord, during the decompression surgery indicated for the patient. The administration will be performed once, without the need for a separate procedure just to receive the substance.
Surgical teams at both hospitals have been trained to execute the protocol. After the intervention, the five participants will enter a rehabilitation program with support from AACD and will be monitored for six months.
Independent committee will monitor possible adverse effects
The monitoring will not be limited to the teams responsible for treatment. An independent committee will oversee the study data and evaluate possible adverse reactions observed after administration.
Among the points to be analyzed is the possibility of the body developing antibodies against polylaminin. This type of evaluation is crucial in a phase 1 trial, where the priority is to understand tolerability and risks before expanding the number of participants.
Research began over two decades ago at UFRJ
The work that led to the current regulatory phase is led by professor Tatiana Coelho Sampaio from the Federal University of Rio de Janeiro and started more than 20 years ago.
The substance is produced in a laboratory from laminin, a protein naturally present in the body. In the Brazilian project, the raw material is obtained from placentas donated by women after childbirth, with their consent.
Structure formed by the substance is studied for its interaction with axons
In the research conducted so far, the transformation of laminin into polylaminin allows the formation of a structure applied directly over the injured area. The studies investigate whether this environment can promote the growth and reconnection of axons, the extensions of neurons involved in transmitting nerve signals.
This does not mean that the substance has been proven to restore movement. The sequence of studies was designed specifically to test safety first and only then verify efficacy with a more robust experimental design and larger groups.
Cristália joined the project in 2018 and established a partnership with UFRJ
Cristália Laboratory became aware of the research in 2018. Three years later, in 2021, it formalized a partnership with UFRJ to develop the product and structure its production on a larger scale.
According to the laboratory, R$ 100 million has already been invested in the project. The company also claims to be currently the only producer of the substance in the world and warns that polylaminin is not commercially available.
Eight patients had already received the substance before the regulatory phase
Human application does not start now. Between 2016 and 2021, eight patients with complete spinal cord injuries participated in a pilot study conducted in Rio de Janeiro and Niterói.
The results were published on August 4, 2026, in the scientific journal Spinal Cord, which specializes in spinal cord diseases and injuries. Six of the eight participants showed improvements of at least two levels on the AIS neurological scale, and some also experienced recovery of movement and positive changes in neurophysiological assessments.
Previous study showed promising results, but did not prove efficacy
Despite the observed changes in participants, the researchers themselves stressed that it is not possible to assert that the improvements were caused by polylaminin. The study involved a small number of people, did not have a control group, and included patients with different types and levels of injury.
Due to these limitations, the results were treated as proof of concept that needed to be confirmed by controlled clinical trials. Three participants died during the follow-up period due to cardiac issues, sepsis, and pneumonia; according to the researchers, these deaths were not related to the administration of the substance.
Anvisa authorized phase 1 in January 2026
Brazil’s National Health Surveillance Agency (Anvisa) approved the regulatory study of phase 1 on January 5, 2026. This approval paved the way for the stage that begins in September at both sites in São Paulo.
In April, the conditions for the compassionate use of the substance were also changed, reducing the previously planned three-month window to three days and restricting access to specific situations.
Phases 2 and 3 should determine if the treatment really works
If phase 1 shows an acceptable safety profile, Cristália may request permission to advance in clinical development.
The efficacy will primarily be investigated in phases 2 and 3, with larger groups and comparisons capable of determining whether the observed effects are genuinely related to the substance.
Polylaminin remains experimental and is not available for sale
Despite over two decades of research and previous applications in studies, polylaminin is still experimental. It does not have registration as a medication and is not available commercially.
This distinction is important because results observed in preliminary studies do not equate to proof that a treatment is safe and effective for widespread use. The laboratory itself warns of scams involving people promising to sell, donate, or facilitate access to the substance.
New phase may answer questions that previous studies left open
The start of the study with five patients represents a significant shift because it places the research within a structured regulatory clinical sequence. The first question now will not be how many patients regained movement, but whether the application presents sufficient safety for development to continue.
Only after this answer will it be possible to advance to larger groups and investigate with greater precision the potential of the substance concerning spinal cord injuries. For research initiated more than 20 years ago, the September step opens a new stage, but it is still far from a conclusion about efficacy.
What stands out most to you in this research: the more than 20 years of development, the start of regulatory tests in humans, or the caution necessary before asserting that a treatment works? Share your opinion in the comments.
