Why and how current EU-Regulations don’t match the needs of regenerative medicine

Examining how culture and the structure of society affect a clinical trial testing an autologous stem cell procedure, it became apparent how efforts to standardize regulations across the EU has advantages but also brings new challenges for regenerative medicines. Professor Hauskeller argues that academic research teams need access to a new system of support for solving these inevitable difficulties. The findings also provide reasons for re-considering how clinical trial norms can be adapted to suit the needs of regenerative medicine.

What questions & challenges are raised?

There are many claims that the current clinical trial (CT) process is in need of reform to meet the needs of developing regenerative medicine (RM) treatments. Issues such as scientific rigour, accessibility, public demand, financial incentives and moral implications have all contributed to calls for integrating more societal considerations. The EU has implemented the EU Tissue and Cells Directive and other policies to help standardise CTs, but differences in regional cultures and policies are not fully addressed and complicate CT implementation. Simple things such as language, trial insurance and post-clinical care provision can slow the process and increase the costs of a CT. In her recent publication, Professor Christine Hauskeller from the University of Exeter discusses how European legislation has affected a large multinational EU clinical trial with autologous cells. Professor Hauskeller has been accompanying the CT from its funding application in 2009 to present, and chronicled the many events and issues encountered. Details of this case study exemplify the need to establish centralised resources to support the complex logistics of European multinational trials in publicly funded research. Also, reforming the CT process should create avenues that support academic clinical research, the only actors that might bring autologous cell therapies into the clinic.