Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)

Abstract Developing effective therapies against chronic wound healing deficiencies is a global priority. Thus we evaluated the safety of two different doses of topically administered autologous APOSEC, the secretome of apoptotic peripheral blood mononuclear cells (PBMCs), in healthy male volunteers...

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Autores principales:	Elisabeth Simader, Denise Traxler, Mohammad Mahdi Kasiri, Helmut Hofbauer, Michael Wolzt, Christoph Glogner, Angela Storka, Michael Mildner, Ghazaleh Gouya, Alexandra Geusau, Carola Fuchs, Claudia Eder, Alexandra Graf, Michaela Schaden, Bahar Golabi, Marie-Bernadette Aretin, Susanne Suessner, Christian Gabriel, Walter Klepetko, Erwin Tschachler, Hendrik Jan Ankersmit
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2017
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/40f54b19104940fea11ec35f70d7405b
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spelling	oai:doaj.org-article:40f54b19104940fea11ec35f70d7405b2021-12-02T16:07:01ZSafety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)10.1038/s41598-017-06223-x2045-2322https://doaj.org/article/40f54b19104940fea11ec35f70d7405b2017-07-01T00:00:00Zhttps://doi.org/10.1038/s41598-017-06223-xhttps://doaj.org/toc/2045-2322Abstract Developing effective therapies against chronic wound healing deficiencies is a global priority. Thus we evaluated the safety of two different doses of topically administered autologous APOSEC, the secretome of apoptotic peripheral blood mononuclear cells (PBMCs), in healthy male volunteers with artificial dermal wounds. Ten healthy men were enrolled in a single-center, randomized, double-blinded, placebo-controlled phase 1 trial. Two artificial wounds at the upper arm were generated using a 4-mm punch biopsy. Each participant was treated with both topically applied APOSEC and placebo in NuGel for 7 consecutive days. The volunteers were randomized into two groups: a low-dose group (A) receiving the supernatant of 12.5 × 106 PBMCs and a high-dose group (B) receiving an equivalent of 25 × 106 PBMCs resuspended in NuGel Hydrogel. Irradiated medium served as placebo. The primary outcome was the tolerability of the topical application of APOSEC. All adverse events were recorded until 17 days after the biopsy. Local tolerability assessment was measured on a 4-point scale. Secondary outcomes were wound closure and epithelization at day 7. No therapy-related serious adverse events occurred in any of the participants, and both low- and high-dose treatments were well tolerated. Wound closure was not affected by APOSEC therapy.Elisabeth SimaderDenise TraxlerMohammad Mahdi KasiriHelmut HofbauerMichael WolztChristoph GlognerAngela StorkaMichael MildnerGhazaleh GouyaAlexandra GeusauCarola FuchsClaudia EderAlexandra GrafMichaela SchadenBahar GolabiMarie-Bernadette AretinSusanne SuessnerChristian GabrielWalter KlepetkoErwin TschachlerHendrik Jan AnkersmitNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 7, Iss 1, Pp 1-8 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Elisabeth Simader Denise Traxler Mohammad Mahdi Kasiri Helmut Hofbauer Michael Wolzt Christoph Glogner Angela Storka Michael Mildner Ghazaleh Gouya Alexandra Geusau Carola Fuchs Claudia Eder Alexandra Graf Michaela Schaden Bahar Golabi Marie-Bernadette Aretin Susanne Suessner Christian Gabriel Walter Klepetko Erwin Tschachler Hendrik Jan Ankersmit Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)
description	Abstract Developing effective therapies against chronic wound healing deficiencies is a global priority. Thus we evaluated the safety of two different doses of topically administered autologous APOSEC, the secretome of apoptotic peripheral blood mononuclear cells (PBMCs), in healthy male volunteers with artificial dermal wounds. Ten healthy men were enrolled in a single-center, randomized, double-blinded, placebo-controlled phase 1 trial. Two artificial wounds at the upper arm were generated using a 4-mm punch biopsy. Each participant was treated with both topically applied APOSEC and placebo in NuGel for 7 consecutive days. The volunteers were randomized into two groups: a low-dose group (A) receiving the supernatant of 12.5 × 106 PBMCs and a high-dose group (B) receiving an equivalent of 25 × 106 PBMCs resuspended in NuGel Hydrogel. Irradiated medium served as placebo. The primary outcome was the tolerability of the topical application of APOSEC. All adverse events were recorded until 17 days after the biopsy. Local tolerability assessment was measured on a 4-point scale. Secondary outcomes were wound closure and epithelization at day 7. No therapy-related serious adverse events occurred in any of the participants, and both low- and high-dose treatments were well tolerated. Wound closure was not affected by APOSEC therapy.
format	article
author	Elisabeth Simader Denise Traxler Mohammad Mahdi Kasiri Helmut Hofbauer Michael Wolzt Christoph Glogner Angela Storka Michael Mildner Ghazaleh Gouya Alexandra Geusau Carola Fuchs Claudia Eder Alexandra Graf Michaela Schaden Bahar Golabi Marie-Bernadette Aretin Susanne Suessner Christian Gabriel Walter Klepetko Erwin Tschachler Hendrik Jan Ankersmit
author_facet	Elisabeth Simader Denise Traxler Mohammad Mahdi Kasiri Helmut Hofbauer Michael Wolzt Christoph Glogner Angela Storka Michael Mildner Ghazaleh Gouya Alexandra Geusau Carola Fuchs Claudia Eder Alexandra Graf Michaela Schaden Bahar Golabi Marie-Bernadette Aretin Susanne Suessner Christian Gabriel Walter Klepetko Erwin Tschachler Hendrik Jan Ankersmit
author_sort	Elisabeth Simader
title	Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)
title_short	Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)
title_full	Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)
title_fullStr	Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)
title_full_unstemmed	Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)
title_sort	safety and tolerability of topically administered autologous, apoptotic pbmc secretome (aposec) in dermal wounds: a randomized phase 1 trial (marsyas i)
publisher	Nature Portfolio
publishDate	2017
url	https://doaj.org/article/40f54b19104940fea11ec35f70d7405b
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Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I﻿)

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Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I)