Polilaminina Enters Regulated Testing as Lead Researcher Moves to Correct Preprint

Overview

• Tatiana Sampaio acknowledged presentation errors in the 2024 human preprint and said a corrected version will clarify data without changing the study’s conclusions.
• Anvisa authorized a phase 1 safety trial on January 5 for five adults with complete thoracic injuries between T2 and T10 treated within 72 hours, with a single intramedullary application.
• Hospital Mater Dei Salvador reported treating patient Paulo Araújo under the authorized research protocol, with neuro- and spine surgeons applying the compound directly at the lesion site.
• HC‑USP’s ethics committee denied compassionate use for a sergeant with a T12 injury, citing insufficient human evidence, procedural risks, and mismatch with trial eligibility.
• Cristália is scaling material supply using screened placentas donated at Itapira’s municipal hospital, which has collected about 140 units since April 2025 for production of the laminin-derived input.