Cell-Easy Manufacturing Process for ATMP Approved for Clinical Trial

Cell-Easy, a French CDMO focused on advanced cell therapies, and the Toulouse University Hospital, obtained IMPD (Investigational Medicinal Product Dossier) approval from the European Medicines Agency for a first-in-human clinical trial. The trial will use an allogeneic treatment developed from an autologous process for patients with ischemic digital ulcers in systemic sclerosis. Cell-Easy developed the manufacturing process from an initially autologous one where the cell donor was the patient himself.

The allogeneic approach uses cells from a single donor to produce therapeutic doses for thousands of patients, making the process cost-efficient and more accessible for patients.

Cell-Easy has designed a process for the large-scale manufacturing of ASCs in compliance with GMP standards required by regulatory agencies. These ASCs will be used in the A-DUSE clinical trial.

“This project represents another remarkable milestone for Cell-Easy, demonstrating our ability to successfully navigate the entire life cycle of advanced therapy medicinal products (ATMP) development,” said Guillaume Costecalde, president at Cell-Easy. “Our collaborative work with physicians, supply chain partners, regulators and policymakers has enabled us to effectively address the intricacies of these therapies and establish rigorous quality standards.”