Laterre, Pierre-François http://orcid.org/0000-0001-5712-7449
Sánchez-García, Miguel
van der Poll, Tom http://orcid.org/0000-0002-9199-5079
de la Rosa, Olga
Cadogan, Kathy-Ann
Lombardo, Eleuterio
François, Bruno http://orcid.org/0000-0002-2531-1652
Funding for this research was provided by:
Horizon 2020 (681031)
Article History
Received: 6 October 2020
Accepted: 22 October 2020
First Online: 25 November 2020
Ethics approval and consent to participate
: The study will be conducted in compliance with the protocol; regulatory requirements; good clinical practice (GCP); consolidated guidelines Committee for Proprietary Medicinal Products (CPMP)/ICH/135/95 (July 1996), adopted in the EU by CPMP EU Commission Directive 2005/28/EC (GCP, April 2005); and the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association. As SEPCELL will be performed across several European countries ethics approval was obtained from ethics review committees at the participating institution in each country. In France, the Comité de Protection des Personnes (CPPSOOM4), at Cabanis Haut, Centre Hospitalier Esquirol. In Spain, The Independent Ethics Committee for Research Involving Medicinal Products (47/864244.9/15) on behalf of The Secretary of the Regional IECm of the Community of Madrid. In Belgium, The Medical Ethics Committee (015/35) for The Vrije Universiteit Brussel. In Italy, Sapienza University Ethics Committee (39 SA_2018) for Sapienza University. In Norway, the Regional Committee for Medical Health Research Ethics (2017/1768/REK midt) at St. Olavs Hospital, Trondheim. In Lithuania, the Lithuanian Bioethics Committee (P-17-50) for the State Budget Institution with Klaipeda Republican Hospital as the designated study site. Consent to participate in SEPCELL was confirmed by subjects (or relatives or legal representative) through a signed informed consent form. The informed consent form includes information that data will be recorded, collected, processed and may be transferred to European Economic Area (EEA) or non-EEA countries in accordance with the European Union Data Protection Regulation (2016/679).
: Not applicable.
: TvdP, PFL, MS and BF are members of the SEPCELL Consortium. OdlR, K-AC and EL are employees of Takeda. The institutions of PFL, MS and BF are study sites. In addition to funding from the European Union, Takeda Pharmaceuticals provided additional funding for the SEPCELL study.