Brazil Moves to Bolster IP After Polylaminin Patent Lapse as First Safety Trial Nears

Overview

• Anvisa has cleared a phase 1 study without a placebo for five adults with complete thoracic spinal cord injuries within 72 hours of trauma.
• Lead researcher Tatiana Sampaio said a further ethics step was approved this week and dosing is slated to begin in early March.
• Cristália argues later stages could use real‑world comparators, while Anvisa says control‑group design will be decided after phase 1 results.
• A small human pilot posted as a preprint reported one full recovery and several partial motor gains in eight patients, which experts caution remains preliminary and unreviewed.
• Judicialized compassionate use has produced 56 court requests and 33 applications outside trials, complicating standardized data collection and trial recruitment.