Funding for this research was provided by:
Austrian Science Fund (P27729)
Innovacell Biotechnologie AG
Received: 14 April 2020
Revised: 15 May 2020
Accepted: 28 May 2020
First Online: 12 June 2020
Ethics approval and consent to participate
: Muscle samples of human origin were taken as a part of clinical trials (EudraCT numbers: 2010-021463-32 and 2010-021871-10). Residual material of patients agreeing to further usage of their cells was used for research purposes following undersigned informed consent. The national authorities in Austria (BASG), Germany (PEI), Czech Republic (SUKL), the UK (MHRA), and Bulgaria (Bulgarian Drug Agency) (for 2010-021463-32 and 2010-021871-10) as well as Sweden (MPA), Switzerland (Swiss Medic), and Slovenia (JAZMP) (for 2010-021463-32) and Italy (Italian Medicines Agency) (for 2010-021871-10) authorized the clinical trials. In each country, at least one (central) ethics commission was addressed and gave a positive opinion on the trial protocols and informed consents. For clinical trial 2010-021463-32, the following ethics commissions expressed their positive opinion: The “Ethikkomission der Medizinischen Universität Graz (23-099 ex 10/11)” in Austria, the “Medizinische Ethik-Komission II der Medizinischen Fakultät Mannheim” in Germany, the “Regional Ethics Committee Stockholm” in Sweden, the “Central Ethics Committee of the Ministry of Health of the Czech Republic” in the Czech Republic, the “National Research Ethics Service NRES Committee London – Chelsea” in GB, the “Republic of Slovenia National Medical Ethics Committee (NMEC)” in Slovenia, the “Комисията по етика за многоцентрови изпитвания” in Bulgaria, the “Comité de Protection des Personnes – CPP Sud Méditerranée IV” in France, and the “Kantonale Ethikkomission Zürich” in Switzerland. For clinical trial 2010-021871-10, the following ethics commissions expressed their positive opinion: the “Ethik-Kommission der Medizinischen Universität Wien” in Austria; the “Medizinische Ethik der Universität Duisburg – Essen” in Germany; the “Ethics commission of Hradec Kralove” in the Czech Republic; the “Комисията по етика за многоцентрови изпитвания” in Bulgaria; the “NHS, Health Research Authority NRES Committee Yorkshire & The Humber – Leeds” in GB; and the “Comitato Etico Azienda Ospedaliero Universitaria Ospedali Riuniti” in Italy.Animal experiments within this study were designed and conducted according to the Austrian National Law TVG/2012 (“Tierversuchsgesetz”) and the European Directive 2010/63/EU. Animal experiment proposals were granted by the Government of Salzburg, Austria (project number: 20901-TVG/96/7-2014), and the Federal Ministry of Science Research and Economy (project number: BMWFW-66.019/0039-WF/V/3b/2016). The animal ethics commission of the Paracelsus Medical University, Salzburg, approved the projects.
: No individual person’s data presented within the study.
: Innovacell Biotechnologie AG, a clinical-stage biotech company, developing cell-based therapies for commercialization, funded this research within this study. Innovacell Biotechnologie AG employed Marco Thurner, Martin Deutsch, Katrin Janke, Martin Deutsch, and Rainer Marksteiner and provided support in the form of salaries for these authors. The specific roles of authors employed by Innovacell Biotechnologie AG are articulated in the “Authors’ contributions” section.