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Cristália and UFRJ begin Phase 1 trials for polylaminin
Cristália and the Federal University of Rio de Janeiro (UFRJ) are launching Phase 1 clinical trials for polylaminin, an experimental substance designed to treat spinal cord injuries. The trials are scheduled to begin on September 24 in Brazil.
The study aims to evaluate the safety of the substance in humans rather than its efficacy, which will be tested in later phases. The trial will recruit five volunteer patients, aged 18 to 72, who have sustained a complete spinal cord injury between the T2 and T10 vertebrae. To qualify, the injury must have occurred within 72 hours of the procedure, and the patient must require spinal decompression surgery.
Participants will receive a single application of polylaminin directly into the injured area during surgery. Procedures will take place at Hospital das Clínicas and Santa Casa de Misericórdia de São Paulo. Following the surgery, patients will undergo rehabilitation at AACD and will be monitored by the research team for six months. Polylaminin was developed based on research by UFRJ professor Tatiana Sampaio, who has studied the protein's potential for over 20 years.
Entities
Anvisa · Cristália · Federal University of Rio de Janeiro · Hospital das Clínicas · Hospital das Clínicas · Santa Casa de Misericórdia de São Paulo · Tatiana Sampaio · UFRJ · Universidade Federal do Rio de Janeiro
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 7 SOURCES] Patients must require surgery within 72 hours of the trauma. noticiacapital.com.br · ohoje.com · ejornais.com.br · dev.tnonline.com.br · jornaldafronteira.com.br · +1 more
- [● 8 SOURCES] The primary objective of this phase is to verify the safety of the substance in humans. itapevinoticias.com.br · noticiacapital.com.br · ohoje.com · ejornais.com.br · dev.tnonline.com.br · +2 more
- [● 2 SOURCES] Clinical procedures will take place at Hospital das Clínicas and Santa Casa de Misericórdia in São Paulo. noticiacapital.com.br · ohoje.com
- [● 8 SOURCES] The initial phase will involve five volunteer patients aged between 18 and 72. itapevinoticias.com.br · noticiacapital.com.br · ohoje.com · ejornais.com.br · dev.tnonline.com.br · +2 more
- [● 17 SOURCES] The study was authorized by the Brazilian National Health Surveillance Agency (Anvisa). noticiacapital.com.br · ohoje.com · ejornais.com.br · dev.tnonline.com.br · jornaldafronteira.com.br · +11 more
- [● 17 SOURCES] Cristália and UFRJ researchers are partnering to conduct clinical trials for polylaminin. itapevinoticias.com.br · noticiacapital.com.br · ejornais.com.br · dev.tnonline.com.br · jornaldafronteira.com.br · +11 more
- [● 17 SOURCES] Eligible patients must have a complete spinal cord injury between vertebrae T2 and T10. noticiacapital.com.br · ejornais.com.br · dev.tnonline.com.br · jornaldafronteira.com.br · rpnews.com.br · +11 more
- [● 17 SOURCES] Phase 1 clinical trials for polylaminin are scheduled to begin on September 24. itapevinoticias.com.br · noticiacapital.com.br · ohoje.com · ejornais.com.br · dev.tnonline.com.br · +11 more
- [● 3 SOURCES] Polylaminin was discovered by UFRJ researcher Tatiana Sampaio. www.acessa.com · jornalenoticias.com.br · tribunadaserra.com.br
- [● 3 SOURCES] Phase 1 clinical trials for polylaminin are scheduled to begin on the 24th of this month. www.acessa.com · jornalenoticias.com.br · tribunadaserra.com.br
- [● 16 SOURCES] The trial will recruit five volunteer patients aged 18 to 72. www.acessa.com · jornalenoticias.com.br · tribunadaserra.com.br · ejornais.com.br · portalg37.com.br · +10 more
- [● 16 SOURCES] Eligible patients must have sustained their injury less than 72 hours prior to the procedure. www.acessa.com · jornalenoticias.com.br · tribunadaserra.com.br · ejornais.com.br · portalg37.com.br · +10 more