spinal cord Treatment for spinal injuries that’s been in use at a small-town lab in Brazil has caused a sensation, with people travelling so far as Mexico to enroll in the program, the government rushing to approve it and a scientist becoming a national hero – and it’s not even been proven to be safe yet in a clinical trial.
But the hype surrounding polylaminin, a protein derived from placentas that is designed to stimulate nerve regeneration, has attracted the attention of thousands of prospective patients around the globe, and dozens of patients have sought out a lawyer to obtain access to the drug. Without clinical evidence of safety and efficacy, experts are cautioning while attempting to differentiate between fact and hope.
Since the early 2000s, animal research has indicated that polylaminin can promote the growth of damaged nerve fibers. Public interest in polylaminin surged after a preprint of a study was promoted last year by the Brazilian company Cristalia, which holds the patent. Although Phase 1 clinical trials are ongoing, public interest in polylaminin has exploded since last year, when a preprint of a study was promoted by the Brazilian pharmaceutical company that holds the patent, Cristalia.
The impact in Brazil has been wide-ranging; for example, popular Brazilian singer Joao Gomes shouted at Sampaio at a Carnival parade this year, “You are the biggest celebrity here. Sampaio said the discovery was a landmark in the world for a female scientist, who is Brazilian.
Proven safe and effective, polylaminin would serve as a major success for a Brazilian industry that long has relied on generic drugs and a country that spends only 1.2% of GDP on research and development, according to the World Bank 2023 data.
The government of President Luiz Inacio Lula da Silva, who is running for reelection this year, has seized on the optimism.
Health Minister Alexandre Padilha said that it was a product that was so important to us that it was the first to be analysed by the newly established Innovation Committee at the state health regulator Anvisa. If the clinical study is successful, then it can be provided to the population as soon as possible. Polylaminin is “one of the early tests” for a variety of experimental treatments,” said Marco Baptista, chief science officer at the Christopher & Dana Reeve Foundation, referring to the multiple treatments currently being tested in early stages.
The foundation was established by the “Superman” actor, who was paralyzed in a 1995 riding accident, and has been investigating promising science around the globe, but doesn’t have high expectations of preliminary results.
“It is not the only approach out there, and we need to see if it’s safe and efficacious,” Baptista said.
The research needs to be successful, although it must have certain criteria, said Delson Jose da Silva, president of the Brazilian Academy of Neurology. The first polylaminin study of humans was conducted in eight patients with complete spinal cord injuries, half of whom were paraplegic and half tetraplegic, who were treated within days of the injury. Two died due to their injuries. However, all 6 survivors regained some voluntary motor control and one person who broke his neck in a car accident was completely recovered after 2 years.
The 23-year-old Freitas, who received polylaminin within 24 hours of being hurt, has emerged as a leading figure in support of the treatment. But some experts indicated concern that the hype over the drug’s promise could result in disappointment.
Luiz Fernando Mozer, 38, a auto painter, was treated a few days after being injured in a motocross accident in early December. The only thing he noticed getting better is that he is able to feel his legs again.
He’s frustrated because he hasn’t been able to recover quickly. “Results just don’t come and we’re anxious to get them.” Patients in Brazil are able to access experimental drugs via the legal system. Since the drug was made known to the public, dozens of lawsuits have been filed in order to get access to polylaminin, Anvisa said.
The buzz might result in desperate patients being vulnerable to exploitation. Chronic disease expert Vanessa Patricia explained that she has had situations where lawyers bill a chronic patient for something that they are not entitled to.
Animal studies and preliminary data from human subjects indicate that polylaminin is most effective when administered within 72 hours of injury and up to three months after, Sampaio said. Anvisa takes 45 days to decide on such requests so some patients have resorted to lawyers. Anvisa has initiated the fast-track process for cases in which there was a clear indication for the treatment, which makes legal action less necessary, Patricia said.
Eighty-four patients have been approved for compassionate use of polylaminin so far, according to Anvisa, 44 of whom were by court order. The cost of representation for patients who want to be able to use polylaminin can go from 15,000 to 300,000 reais ($3,000 to $60,000).
Sampaio says she’s no longer able to handle the cases personally, and that some may be accompanied by 24-hour court orders to treat the patient before researchers can complete their evaluation of the case. She insists, however, that she is dedicated to the research and is hoping that trials will show the clinical benefit of the drug.
Rogerio Almeida, vice president of research and innovation at Cristalia, said it is donating the drug to acute patients following Anvisa’s green light. Cristalia, located in the countryside of Sao Paulo state, has been spending more than 110 million reais ($22 million) on the development of polylaminin.
The Phase 1 trial approved by Anvisa will evaluate the safety of polylaminin in five patients between the ages of 18 and 72 with acute complete thoracic spinal cord injuries who have undergone surgical intervention within 72 hours of injury.
A member of the non-profit that advocates science-based public policy, Natalia Pasternak said that public documents fail to explain why Anvisa approved the study. She’s asking for more evidence in court.
A controversial spinal cord treatment being offered in Brazil has attracted widespread attention from patients, families, healthcare professionals, and legal experts. While many individuals living with severe injuries view the experimental spinal cord procedure as a source of hope, concerns remain regarding the lack of conclusive scientific evidence supporting its effectiveness.
The growing popularity of the spinal cord treatment has also led to legal disputes and increased scrutiny from medical authorities who are calling for stronger clinical validation.
Why the Spinal Cord Treatment Is Generating Interest
For people living with paralysis and neurological impairments, advances in spinal cord research offer the possibility of improved mobility and quality of life. The Brazilian treatment has gained attention because it claims to support recovery in patients with serious spinal cord injuries.
Many patients are willing to explore innovative therapies when traditional options provide limited results, contributing to the strong public interest surrounding the spinal cord procedure
The controversy highlights the urgent need for continued investment in spinal cord research and clinical development. Scientists around the world are exploring new approaches to spinal cord regeneration, nerve repair, and rehabilitation technologies.
Future clinical trials may help determine whether the Brazilian spinal cord treatment can become a validated medical option or whether additional modifications and research will be required.
