EMA eyes stem cell research breakthrough
pharmafile | May 18, 2010 | News story | Research and Development | EMA, Stem cells, stem cell
European regulators are readying themselves to deal with the region’s first marketing authorisation application for a stem cell product.
The European Medicines Agency hosted its first workshop on stem cell based treatments last week as part of a public consultation on developing dedicated regulatory guidance for stem cell R&D.
Commenting on the progress made, EMA executive director Thomas Lonngren said the discussions at the workshop would “pave the way for the first European marketing authorisation application for a stem cell product”.
The EMA has already been informed by one European manufacturer of its intention to submit the first application for marketing authorisation for a stem cell-based product.
The Agency estimates that some 40 clinical trials within the EU are currently exploring the use of stem cells in regeneration of lost or damaged tissue (heart, skin, bone, spinal cord, liver, pancreas and cornea) and in haematological or solid-organ malignancies.
One trial due to begin soon in the UK is a phase I study of ReNeuron’s stem cell therapy for patients disabled by stroke.
Research into stem cell-based therapies has increased in the past few years with ongoing clinical studies in adult stem cells, exploration of embryonic stem cells and induced pluri-potent stem cells (artificially reprogrammed adult cells) for possible future clinical applications.
The workshop consisted of international experts from academia, regulatory bodies and the pharma industry working together to review both opportunities and difficulties in developing stem cell-based therapies including regulatory challenges.
The resulting draft reflection paper was developed by the Agency’s Committee for Advanced Therapies (CAT), together with the Cell-based Products Working Party and Biologics Working Party.
Christian Schneider, chair of the CAT, said: “Stem cells hold the promise of an unlimited source of cells for therapeutic applications to treat patients who have no or only unsatisfactory treatment options.
“However, these therapies bear certain risks, such as tumourigenicity and immuno-rejection, and hence need to be carefully regulated with the input from multi-disciplinary expertise.”
The Agency’s committees have been advising pharma companies on stem-cell research at different stages of development for several years.
The draft reflection paper on stem cell-based medicinal products was released on 16 March 2010 and is available here.
Further comments can be submitted until 30 June 2010 and a ‘reflection paper’ is then expected to be finalised by the end of 2010 and will be published on the Agency’s website.
Ben Adams
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