Polilaminin Enters Phase 1 Trial in Brazil as Court-Authorized Case Reports Early Gains

Overview

• Anvisa approved a phase 1 safety trial designed for five patients with complete, acute spinal‑cord injury, with one-time dosing and six months of follow‑up.
• In Maranhão, police officer Romildo Leobino received the compound 28 days after his injury under a court order and has shown improved breathing, muscle strength and trunk control, according to his hospital and family.
• Developer Tatiana Sampaio at UFRJ leads the research with Cristália as the manufacturing partner, and the Health Ministry has backed further testing.
• Uncontrolled early cases include Bruno Drummond, treated within 24 hours in 2018, who later regained substantial function, but efficacy awaits confirmation in later trial phases.
• Sampaio says the international patent was lost over unpaid fees after funding cuts, and Brazil’s patent was only granted in 2025 with limited exclusivity remaining.