THERAPEUTIC INNOVATION IN SPINAL CORD INJURY IN BRAZIL: CLINICAL ADVANCES IN POLYLAMININ AND REGULATORY CHALLENGES
DOI:
https://doi.org/10.63330/aurumpub.034-016Keywords:
Regenerative medicine, Regulatory challenges, Spinal cord injury, Therapeutic innovation, PolylamininAbstract
Spinal cord injury represents a major clinical and social challenge in Brazil, requiring innovative therapeutic strategies capable of promoting neural regeneration and functional recovery. This chapter aims to analyze clinical advances related to the use of polylaminin as a therapeutic biomaterial for spinal cord injury in the Brazilian context, as well as to discuss the main regulatory challenges for its incorporation into the health system. The methodology consisted of a narrative review of national and international scientific literature, in addition to the analysis of regulatory documents concerning clinical research and advanced therapy medicinal products in Brazil. The results indicate that polylaminin shows promising potential in promoting axonal growth, reducing inflammatory response, and improving functional outcomes in experimental models, with prospects for future clinical application. However, regulatory barriers remain, including requirements for safety validation, production standardization, and ethical oversight in clinical trials. It is concluded that although polylaminin represents a significant advance in regenerative medicine, its therapeutic consolidation in Brazil depends on strengthening translational research and regulatory harmonization.
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