São Paulo Council Honors Polylaminin Scientist as Anvisa Approves Compassionate Use for 33 Patients

Overview

• - The São Paulo City Council voted unanimously to award Tatiana Sampaio the Anchieta Medal, the City’s Certificate of Gratitude, and the title of Paulistana Citizen, with a ceremony date still to be set.
• - Anvisa confirmed authorizations for 33 patients to receive polylaminin under compassionate use following court decisions, with requests submitted by study sponsor Cristália and subject to agency monitoring.
• - The compassionate-use pathway operates outside clinical trials and does not establish efficacy, and Anvisa separately cleared a phase 1 safety study in January.
• - Sampaio has acknowledged errors in a 2024 preprint, is preparing a revised manuscript after rejections by Nature Communications and the Journal of Neurosurgery, and says she will only release it after peer-reviewed acceptance.
• - The preprint summarized two decades of work, including eight human cases, but external researchers cited data inconsistencies—such as improvements logged for a patient who died soon after the procedure—as Cristália’s reported R$100 million investment underscores the stakes.