Travelling cells - Harmonized European Regulation and the BAMI stem cell trial
Reason for embargo
Under indefinite embargo due to publisher policy. The final published version is available from the publisher via the link in this record.
Harmonized regulation of clinical trials seems necessary in order to speed up approval processes and the time from bench to bedside for novel stem cell treatments. Europe is comprised of countries with diverse regulatory and health care systems and the regulators’ aim to unify practice across them provides an opportunity to study the effects of harmonization through regulation and novel institutions. We report findings from a long-term study alongside the first multinational European stem cell clinical trial that applied the harmonised approval procedures and follows the regulations in stem cell clinical trial practice standards introduced over the past decade. Adapting to this regulatory environment was costly in terms of trial implementation and caused delays in patient recruitment. That the stem cells for autologous use had to be transported all over Europe for processing in licensed centres stands out among the costly complications the teams had to address. We conclude that academic trials with little industry support are currently hampered by harmonised regulation. Such trials depend on complex cross-area expertise for implementation. The academic and public sectors have insufficient access to such information. In order to facilitate all promising routes toward a future stem cell medicine, a central support institution bundling expertise in handling the technicalities of implementing multinational trials in Europe is needed.
This is the author's version of the article. The final published version is available from the publisher via the link in this record.
Published in 'Stem Cells in Clinical Translation: Safety, Ethics and Regulation'. Stem Cells in Clinical Translation Series: Vol. VI. Editors: Pham, Phuc Van, Rosemann, Achim (Eds.)