The ADIPOA-2 consortium met for a plenary meeting on September 3, 2019, in Dublin.
This was a critical meeting to assess progress, obstacles and achievements in the ADIPOA2 clinical trial. Every partner in the clinical, manufacturing and scientific arenas was represented. Some key points have emerged during this project summit meeting on which all the partners are in strong agreement: there has been a great deal of progress in implementing the clinical trial at orthopaedic hospitals across Europe. For all of these hospitals, this is an innovative and ground-breaking technology and requires a multidisciplinary and coordinated approach, which has been successfully achieved. In addition, a multinational clinical trial such as this requires a comprehensive approach in terms of regulatory affairs in several European countries, as well as the implementation of harmonised protocols. This has all been achieved and a great deal has been learned about regulatory strategies for cellular therapies in Europe. On another level, complex manufacturing protocols have been put in place and validated in GMP facilities in France, Ireland and Germany.
“We have been able to advance the progression of complex cell therapies across Europe and learned valuable lessons about clinical trial implementation, national and harmonised approaches to the regulation of manufacturing and clinical testing. We have a consortium of partners from France, Germany, Italy, Ireland, Netherlands and UK that is strongly aligned and everyone shares the same vision and determination of delivering innovative therapies to patients. We have opened up strong opportunities for commercialisation and we expect to see the fruits of this in the near future. Because of the support projects such as this receive from Horizon programmes, there is every reason to predict that Europe will continue to be a global leader in cell therapy”.