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On the evening of 9 September 2025, Brazil’s leading newscast featured a story about a dramatic recovery from spinal cord injury. Bruno Drummond, 31, diagnosed with quadriplegia after a 2018 car accident, had received an experimental treatment, an injection of a compound called polylaminin, within 24 hours after the accident. Now, he was walking, descending stairs, and playfully dancing for the camera.

The scientist leading the research, biologist Tatiana Sampaio of the Federal University of Rio de Janeiro, had just shared the results from a small pilot study, in which Drummond was a participant, at a press conference held by the pharmaceutical company producing polylaminin. Brazilian media—and, soon, the public—were spellbound. Sampaio became a national celebrity: She met with Brazil’s president, Luiz Inácio Lula da Silva, and appeared on the cover of Forbes. Online campaigns have called for her to receive a Nobel Prize. The exuberant press coverage, amplified by social media, prompted dozens of patients with spinal cord injury to demand immediate access to polylaminin, and more than 30 people have received injections.

Brazilian researchers, however, are concerned. The pilot study was too small to show polylaminin can treat spinal cord injuries, they say, and some see methodological flaws. And, they add, patients getting an experimental treatment outside of clinical trials may not be thoroughly monitored for potential risks. A phase 1 trial testing the approach’s safety is scheduled to start this month. “We do not yet know the toxicity, the possible side effects in a larger number of individuals, or the appropriate and effective dose,” says Sonia Brucki, a neurosurgeon at the Clinic Hospital at the

University of São Paulo (USP).

Sampaio agrees the data are preliminary but says, “I think—and my verb is ‘think’—that they strongly suggest there may be some effect.” She developed the treatment by creating a polymer from the naturally occurring protein laminin, which is part of the extracellular matrix, a network of molecules that surrounds cells and acts as a scaffold to support and organize tissues. In the nervous system, the protein helps direct the growth of axons—the long projections of neurons that carry electrical impulses between the brain, spinal cord, and the rest of the body. Sampaio’s team hoped that at the site of an injury, polylaminin could stimulate the growth and reconnection of nerve fibers, potentially restoring some lost functions.

The researchers have published studies showing polylaminin injections improve motor performance in rats during the acute phase of spinal cord injuries, when inflammation and damage are still unfolding, and in dogs with chronic injuries. In 2022 and 2023, the pharmaceutical company Cristália acquired key patents related to polylaminin.

The initial clinical trial enrolled eight patients who had recently sustained spinal cord injuries classified as “complete,” meaning movement and sensation are entirely lost below the level of the injury. All got an injection of placenta-derived polylaminin directly into their spinal cords within hours or days of their accident. Drummond’s recovery was the most dramatic, but six participants were said to regain some degree of voluntary motor control. Three of the eight patients died during the study, reportedly from causes unrelated to the treatment.

Based on those early results, reported in a 2024 preprint, people with spinal cord injuries from across Brazil have sought access to polylaminin under “compassionate use”—a regulatory pathway by which people can receive an unapproved treatment for a serious, debilitating condition with no therapeutic alternative. As of 9 March, 32 people had received injections after Brazil’s regulatory body, the Health Regulatory Agency (Anvisa), authorized their requests.

Unfortunately, the data available so far don’t show the trial participants’ improvements are because of polylaminin, warns Eduardo Alho, a neurosurgeon at the Syrian-Lebanese Hospital in São Paulo. Immediately after an injury, some patients show a transient loss of neurological function, known as spinal shock, but may spontaneously recover some motor and sensory function days or weeks later. That’s “exactly the phase when [Sampaio’s] patients started to improve.” Alho adds that some of the patients’ injuries may not have been as severe as initially reported, because it is challenging to assess spinal cord injuries right after trauma.

Others say the trial’s small size and the lack of a control group receiving standard care such as surgery and rehabilitation also weaken the conclusions. “It’s a very small number of people to claim that their clinical progression is or is not related to polylaminin,” says Alicia Kowaltowski, a biochemist at USP who has been tracking the polylaminin case.

Sampaio agrees that “we cannot claim proof of efficacy within the parameters of science.” But the pilot study produced “results that have never been achieved before,” she says.

She says multiple rigorous exams excluded from the study patients with incomplete injuries and those in spinal shock. She adds that the team initially planned to include a control group. But after Drummond’s improvement, they decided it would be unethical to withhold a promising treatment from other participants, and an independent university committee agreed.

Sampaio also says her team has been trying to publish the results in a peer-reviewed journal. Some reviewers have raised the possibility of spontaneous recoveries and have asked for a clearer explanation of polylaminin’s mechanism of action, she says. Another issue is that the study was registered on an official trial platform only after some participants had already been enrolled, Sampaio acknowledges, and some journals require preregistration. In future submissions, the authors plan to use a revised version of the paper, which corrects certain figures and addresses some of the criticisms.

Anvisa selected polylaminin as one of four priority topics for study and in January authorized Cristália to begin a phase 1 clinical trial to assess safety. The five-person trial, in which all participants will get a polylaminin injection, will be conducted according to Anvisa’s official standards, and is the first step in what is typically a yearslong process to provide the evidence to support an approval decision.

“Hopefully, as studies proceed, the current media attention will subside,” Kowaltowski says, “and well-conducted, controlled studies will show whether the treatment is safe and whether it has real therapeutic potential.”