Researcher Tatiana Sampaio informed that the study on polylaminin will undergo peer review in a scientific journal. The statement was made this Wednesday. Ela leads work on Universidade Federal of Rio of Janeiro on the placenta-derived protein. The experimental treatment seeks to regenerate nerves in spinal cord injuries.
The scientist did not provide details about which publication accepted the text or the expected date for release. The announcement comes after previous rejections in two magazines. Especialistas calls for more evidence of safety and efficacy before large-scale applications.
Versão’s previous study faced rejections
The preliminary research manuscript had already been submitted to journals such as Nature Communications and Journal of Neurosurgery. Ambas declined to publish. The editors pointed out divergences in the patient recovery rate and the lack of prior registration of the clinical trial in an international bank.
Tatiana Sampaio admitted mistakes in a previous chart. A patient who died a few days after the procedure appeared with improvement data recorded 400 days later. The researcher attributed the problem to a typing error in the participant’s data.
Outros points questioned involved the presentation of electromyography exams and explanations about the state of spinal cord shock in the cases evaluated. The new version corrects these aspects, according to the scientist.
Polilaminina is still in the initial testing phase
Placenta-derived protein stimulates nerve regeneration in animal models. Preliminary Resultados in humans emerged from a study of eight patients. Cristália, which holds the patent, invested more than R$110 million in development.
Até At the moment, there is no final scientific publication on the topic. What is circulating is a pre-print version, subject to corrections.
- Ensaios phase 1 clinical trials evaluate safety in small group of patients
- Fase 2 and 3 test efficacy, doses and adverse effects in larger populations
- Registro sanitary in Anvisa occurs only after success in previous steps
The regulatory agency authorized the start of phase 1 for five patients with complete acute injuries. The study is still awaiting final approval from the ethics committee.
Compassionate Uso already serves dozens of patients
Anvisa released experimental treatment on a compassionate basis in severe cases without alternatives. Cristália reported that 84 patients received authorization. Desse total, 44 came by court decision and 40 by administrative means.
Esses uses are not part of the official research protocol. Patients do not receive systematic follow-up from the Tatiana Sampaio team.
Especialistas heard in previous reports reinforces the need for caution. Academia Brasileira of Neurologia and international researchers argue that promising early-phase results do not replace robust evidence from controlled trials.
Próximos steps depend on scientific validation
Phase 1 should begin soon at USP’s Hospital of Clínicas. The institution’s ethics committee is still analyzing the protocol. The initial expectation was for a faster start, but there were administrative delays.
Pesquisadores follows the case with interest. Polylaminin represents an innovative but still experimental approach. Definitive Resultados will only come after completion of the complete clinical phases.
Public interest grew after reports of patients regaining movement. The scientific community calls for a balance between hope and methodological rigor.