Suzhou-based stem cell therapy specialist Regend Therapeutics announced that the US Food and Drug Administration (FDA) has granted its airway basal layer stem cell product, Pulmovinci, Orphan Drug Designation (ODD) for the treatment of idiopathic pulmonary fibrosis (IPF). This designation is a significant milestone in the development of Pulmovinci, highlighting its potential to address a rare and severe lung disease.
Background and Clinical Trials
Pulmovinci is an updated version of REGEND001, which has demonstrated good safety and preliminary efficacy in clinical trials for IPF in China. The product is designed to target the underlying causes of IPF by leveraging the regenerative capabilities of stem cells, aiming to provide a novel therapeutic approach for patients with this debilitating condition.-Fineline Info & Tech
