Document is current
Any future updates will be listed below
-
Authors
Raczynska, Dorota
Ernest, Jan
Baumane, Kristine
Sagong, Min
Akiyama, Kunihiko
Rauschning, Winrich https://orcid.org/0009-0007-8567-0482
Vajas, Attila
Nowosielska, Agnieszka
Dusova, Jaroslava
Majtánová, Nora
Oleksy, Piotr
Kuneva, Irina
Resch, Miklos
Lange, Natalia
Briede, Eliza
Bajdik, Beáta
Jeong, Areum
Kozub, Barbara
Papp, Andras
-
Clinical Trials BETA
Clinical trials referenced in this document:
2021-004530-11 at EU Clinical Trials RegisterDocuments that mention this clinical trial
- License Information
-
More Information
Article History
Received: 1 November 2025
Accepted: 14 January 2026
First Online: 31 January 2026
Declarations
:
: Dorota Raczynska, Jan Ernest, Kristine Baumane, Min Sagong, Kunihiko Akiyama, Attila Vajas, Agnieszka Nowosielska, Jaroslava Dusova, Nora Majtnov, Piotr Oleksy, Irina Kuneva, Miklos Resch, Natalia Lange, Eliza Briede, Beta Bajdik, Areum Jeong, Barbara Kozub, and Andras Papp received research grants/investigator fees from Alteogen Biologics Inc. for conducting this study. Winrich Rauschning received consulting fees from Alteogen Biologics Inc. No other conflicts of interest exist.
: This study was conducted in accordance with the Declaration of Helsinki of 1964 and its later amendments. All participants provided written informed consent before participation. The study protocol and subsequent amendments were approved by the institutional review boards/ethics committees at each participating site. Participants did not receive a stipend; however, their travel expenses were reimbursed. Additional consent was obtained for the pharmacokinetics substudy.A complete list of ethics committees and approval reference numbers is provided in Table .
