The European Medicines Agency (EMA) has, for the first time, assembled European and international experts across the pharmaceutical industry to review opportunities for stem cell-based therapies and to discuss regulatory challenges.

The workshop is part of a public consultation process to draft the first dedicated regulatory guidance document on stem-cell research and development.

Committee for Advanced Therapies chair Christian Schneider said that stem cells hold the promise of an unlimited source of cells for therapeutic applications.

“However, these therapies bear certain risks, such as tumourigenicity and immunorejection, and hence need to be carefully regulated with the input from multi-disciplinary expertise”, said Schneider.

Clinical studies in adult stem cells and the exploration of embryonic stem cells and induced pluri-potent stem cells (artificially reprogrammed adult cells) have increased dramatically in the past few years leading to a growing need for regulation.

According to the EMA, within the European Union, some 40 clinical trials are currently exploring the use of stem cells in regeneration of lost or damaged tissue and in haematological or solid-organ malignancies.

The agency has also confirmed that at least one European manufacturer has announced their intent to submit the first application for marketing authorisation for a stem cell-based product.