October 23, 2025
Headline Patrol: Brazilians Break On Through
Sam Maddox
Here's a recent spinal cord injury headline that is a bemusing Brazilian clickbrick: Brazilian Breakthrough Drug Shows Promise in Reversing Spinal Cord Injuries
Real headline, although it’s not like it ran in the New York Times or anything. This one is from Heart & Soul, “a reliable source for content, both print and digital, focused in the areas of women’s health, wellness and fitness:”
“A new breakthrough drug from Brazil called polylaminin is currently creating a tangible buzz in the medical community.”
OK, real buzzy for sure, but this barely rises to the threshold of U2FP tangibility. It relates to a study of acute SCI, which matters but not on a must-know basis for people already living with SCI. Also, the buzz is heavily press released and upon closer inspection, not backed by published preclinical or clinical data, or third party validation.
The reporting covers a small clinical trial in Brazil, led by Tatiana Coelho de Sampaio, a scientist at the Federal University of Rio de Janeiro (UFRJ). She produced a single dose injectable drug called polylaminin, made from laminin derived from placental tissue. Laminin is a common protein in the body and has been studied in great detail over the years for its role in nerve regeneration.
Coelho de Sampaio has partnered with Brazil biotech Cristália. They claim that polylaminin helps damaged nerves grow again by assembling as a sort of bio-scaffold to direct and augment nerve plasticity.
From a Cristália press release in September (translated from Portuguese):
The project began in 2007 with Dr. Tatiana's team and was incorporated by Cristália in 2018. In 2021, the partnership with UFRJ was formalized. To date, about R$ 28 million [$5.1 million dollars] has been invested in research and infrastructure at Cristália's Biotechnology facility in Itapira, where the product is manufactured.
Polylaminine is produced naturally by the body in the development of the nervous system and, as discovered by the UFRJ team, can be obtained from the human placenta. “It’s a more affordable and safe alternative than stem cells. Our studies are at a more advanced stage, because the stem cells have unpredictability after application," explains Dr. Tatiana.
Scientific Validation?
There’s not much beyond a 2010 paper authored by Coelho de Sampaio, “Polylaminin, a polymeric form of laminin, promotes regeneration after spinal cord injury.” From the paper:
Here we investigated whether a biomimetic polymer of laminin assembled on pH acidification, henceforth called polylaminin, could be used to treat SCI in rats. Acute local injection of polylaminin, but not of nonpolymerized laminin, improved motor function after thoracic compression, partial or complete transection. In the latter case, the BBB score [a finely graded, 21-point measure of motor function] for open field locomotion 8 wk after lesion increased from 4.2 ± 0.48 to 8.8 ± 1.14 in animals treated with polylaminin of human origin. Accordingly, neurons retrogradely labeled from the sublesion stump were detected in the spinal cord and brain stem, indicating regrowth of short and long fibers across a complete transection. Polylaminin also played an unsuspected anti-inflammatory role, which underlies the early onset of its positive effects on locomotion from the first week after treatment.
Coelho de Sampaio did not publish again about preclinical polylaminin until 2024: Return of Voluntary Motor Contraction After Complete Spinal Cord Injury: a Pilot Human Study on Polylaminin.
The paper describes the clinical trial from the headline. It also details more animal work to justify the human use (“. . . rats treated with polylaminin after mild SCI show better motor performance than rats not receiving any treatment”).
The paper is a preprint; that means it comes with a clear caution that it has not been peer reviewed or certified.
Preprints are preliminary reports of work that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
“Should not be reported in news media.”
Why would a paper linger for a year and a half without peer review? Because it cannot pass peer review?
Oh well, let’s look anyway. Here’s what the paper reports. Ten AIS A (motor complete) patients with day-old spinal cord injuries were recruited. Eight were enrolled. Polylaminin was injected into the spinal cord in preserved tissue above and below the lesion epicentre. Three regained motor control (converted to AIS C or D, at the 1-month. Three others converted to grade C after 3 months.
How does it work? From the preprint: nerve growth, regeneration, and pattern generation:
Our finding that a single-dose therapy was effective in promoting functional recovery after SCI indicates that a short-term contact with polylaminin is sufficient to impel the damaged tissue into a pro-regenerative mode. In this regard it has been previously shown that a single encounter with laminin dramatically accelerates axonal growth of sensory neurons in vitro.
An alternative explanation is that the injected protein, particularly in the polymerized form, remains active in the spinal cord for sufficient time to support elongation of the fibres sprouting after lesion. Another intriguing point is that the functional recovery observed in the present study occurred without parallel signs of robust tissue regeneration that could be detected by image analyses. This does not rule out motor and sensory recovery due to axonal regeneration, as it is possible that few regenerating axons could be enough to input pattern rhythm over intrinsic medullary pattern generator centers.
This polylaminin story needs a big asterisk, or black box, for what is not mentioned in the headlines. Three of the eight trial participants died, two early on, one due to pneumonia, one to pericardial effusion (fluid in the sac around the heart). Another died after a month, due to sepsis.
Fair question to ask: are these deaths related to the treatment? Here’s Coelho de Sampaio, in the paper:
. . . pneumonia and sepsis . . . could in principle be related to an eventual sustained anti-inflammatory state provoked by the treatment, as polylaminin has been shown to display anti-inflammatory properties. At this point, we cannot completely rule out this possibility.
Tatiana Coelho de Sampaio (Photo: FAPERJ)
To be continued, probably, if they can work out the safety questions. Further clinical trials have not yet been cleared by Anvisa, Brazil’s regulatory agency for drug development.
Coelho de Sampaio, at a press conference in September announcing the trial results:
“I am very conservative about the idea of saying ‘we have here a new drug that serves this purpose.’ It is difficult, it is a very big responsibility.”
The data compels her to come forward, she says. "I no longer have the right to be conservative. So at this moment, I have to take the risk."
As usual, we'll keep an eye on what, if anything, happens next.
Stay curious.
