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Safety and clinical efficacy of the secretome of stressed peripheral blood mononuclear cells in patients with diabetic foot ulcer—study protocol of the randomized, placebo-controlled, double-blind, multicenter, international phase II clinical trial MARSYAS II

Crossref DOI link: https://doi.org/10.1186/s13063-020-04948-1

Published Online: 2021-01-06

Published Print: 2021-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Gugerell, Alfred https://orcid.org/0000-0002-5178-9967
Gouya-Lechner, Ghazaleh

Hofbauer, Helmut

Laggner, Maria

Trautinger, Franz

Almer, Gabriele

Peterbauer-Scherb, Anja

Seibold, Marcus

Hoetzenecker, Wolfram

Dreschl, Christiane

Mildner, Michael

Ankersmit, Hendrik Jan
Funding

Funding for this research was provided by:

Aposcience AG
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Article History

Received: 3 April 2020

Accepted: 7 December 2020

First Online: 6 January 2021

Ethics approval and consent to participate

: The study is approved by the ethics committees of Upper Austria (approval number 1139/2018) and Carinthia (approval number MZ 37/18). Written informed consent will be obtained from all study participants. There are no financial and other competing interests for principal investigators.

: Not applicable.

: HJA and HH are minor shareholders of APOSCIENCE AG which developed and produces the investigated secretome and is the sponsor of this study. All other authors declare no competing interests.

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