The National Health Surveillance Agency (Anvisa) authorized the start of the clinical study to evaluate the safety of using the drug polylaminin in the treatment of acute spinal cord trauma, which is an injury to the spinal cord or spine.
In the announcement made this Monday (5), the Minister of Health, Alexandre Padilha (on the left, in the photo), highlighted that the research will be a important milestone for those who have suffered a spinal cord injury and also for their families.
“Each scientific advance is always a new, renewed hope,” said Padilha.
Research at a public university
The minister considers that the product is a radical innovation and uses 100% national technology. Studies with polylaminin are developed by researchers from the Federal University of Rio de Janeiro (UFRJ)led by professor Tatiana Sampaio, in partnership with the Cristália laboratory.
According to Padilha, the research has already shown promising results in movement recovery. In this first phase, the study of polylaminin will be carried out in five volunteer patients with acute injuries of the thoracic spinal cord between the T2 and T10 vertebrae..
These people included in the study must have surgery indicated less than 72 hours after the injury. The venues will still be defined by the responsible company. Throughout the structuring of the project, the Ministry of Health invested resources for basic research.
Priority
According to Anvisa’s CEO, Leandro Safatle, the approval of the start of the polylaminin clinical study was prioritized by the agency’s innovation committee with the aim of accelerating research and registrations of broad public interest.
“A 100% national research, which strengthens science and health in our country”, stated Leandro Safatle.
Research with the polylaminin protein, present in several animals, including humans, aims to evaluate the safety of applying the medicine and identify possible risks for continued clinical development.
The sponsoring company will be responsible for systematically collecting, monitoring and evaluating all adverse events, including non-serious ones, ensuring the safety of participants.
