22 juin 2012 5 22 /06 /juin /2012 12:17
Gintuit cell therapy approval signals shift at US regulator Charles Schmidt Nature Biotechnology 30, 479 (2012) Organogenesis Gintuit will be used in dental care to correct gum pockets. On March 12, the US Food and Drug Administration (FDA) approved a cell-based treatment for gum recession developed by Canton, Massachusetts–based Organogenesis. Dubbed Gintuit, the cell therapy was the FDA's first approval for regenerative medicine in dental care. Importantly, the FDA's Center for Biologics, Evaluation and Research (CBER) evaluation of the neonatal foreskin–derived fibroblast/keratinocyte therapy, delivered in a biodegradable scaffold under a Biologic License Application (BLA), provides important pointers for how the agency plans to evaluate other regenerative therapies and signals a shift from oversight by the Center for Devices and Radiological Health (CDRH). In 1998, a similar cell and scaffold therapy developed by the same company, Apligraft, was evaluated and approved by CDRH under a class III premarketing approval. “This was a practice run for what CBER will ask of other regenerative treatments coming down the line,” says Evan Snyder, chair of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee, which deliberated over Organogenesis' Gintuit application.