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
BACKGROUND: Diabetes and its sequelae such as diabetic foot ulcer are rising health hazards not only in western countries but all over the world. Effective, yet safe treatments are desperately sought for by physicians, healthcare providers, and of course patients.
METHODS/DESIGN: APOSEC, a novel, innovative drug, is tested in the phase I/II study MARSYAS II, where its efficacy to promote healing of diabetic foot ulcers will be determined. To this end, the cell-free secretome of peripheral blood mononuclear cells (APOSEC) blended with a hydrogel will be applied topically three times weekly for 4 weeks. APOSEC is predominantly effective in hypoxia-induced tissue damages by modulating the immune system and enhancing angiogenesis, whereby its anti-microbial ability and neuro-regenerative capacity will exert further positive effects. In total, 132 patients will be enrolled in the multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-ranging phase I/II study and treated with APOSEC at three dose levels or placebo for 4 weeks, followed by an 8-week follow-up period to evaluate safety and efficacy of the drug. Wound area reduction after 4 weeks of treatment will serve as the primary endpoint.
CONCLUSION: We consider our study protocol to be suitable to test topically administered APOSEC in patients suffering from diabetic foot ulcers in a clinical phase I/II trial.
TRIAL REGISTRATION: EudraCT 2018-001653-27 . Registered on 30 July 2019. ClinicalTrials.gov NCT04277598 . Registered on 20 February 2020.
TITLE: "A randomized, placebo-controlled, double-blind study to evaluate safety and dose-dependent clinical efficacy of APO-2 at three different doses in patients with diabetic foot ulcer (MARSYAS II)".
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
Trials - 22(2021), 1 vom: 06. Jan., Seite 10 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Gugerell, Alfred [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 17.06.2021 Date Revised 17.06.2021 published: Electronic ClinicalTrials.gov: NCT04277598 Citation Status MEDLINE |
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| doi: |
10.1186/s13063-020-04948-1 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM31971554X |
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| 100 | 1 | |a Gugerell, Alfred |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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 |
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| 500 | |a Date Revised 17.06.2021 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04277598 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Diabetes and its sequelae such as diabetic foot ulcer are rising health hazards not only in western countries but all over the world. Effective, yet safe treatments are desperately sought for by physicians, healthcare providers, and of course patients | ||
| 520 | |a METHODS/DESIGN: APOSEC, a novel, innovative drug, is tested in the phase I/II study MARSYAS II, where its efficacy to promote healing of diabetic foot ulcers will be determined. To this end, the cell-free secretome of peripheral blood mononuclear cells (APOSEC) blended with a hydrogel will be applied topically three times weekly for 4 weeks. APOSEC is predominantly effective in hypoxia-induced tissue damages by modulating the immune system and enhancing angiogenesis, whereby its anti-microbial ability and neuro-regenerative capacity will exert further positive effects. In total, 132 patients will be enrolled in the multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-ranging phase I/II study and treated with APOSEC at three dose levels or placebo for 4 weeks, followed by an 8-week follow-up period to evaluate safety and efficacy of the drug. Wound area reduction after 4 weeks of treatment will serve as the primary endpoint | ||
| 520 | |a CONCLUSION: We consider our study protocol to be suitable to test topically administered APOSEC in patients suffering from diabetic foot ulcers in a clinical phase I/II trial | ||
| 520 | |a TRIAL REGISTRATION: EudraCT 2018-001653-27 . Registered on 30 July 2019. ClinicalTrials.gov NCT04277598 . Registered on 20 February 2020 | ||
| 520 | |a TITLE: "A randomized, placebo-controlled, double-blind study to evaluate safety and dose-dependent clinical efficacy of APO-2 at three different doses in patients with diabetic foot ulcer (MARSYAS II)" | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a (Impaired) wound healing | |
| 650 | 4 | |a Biological | |
| 650 | 4 | |a Clinical trial protocol | |
| 650 | 4 | |a Diabetic foot ulcer | |
| 650 | 4 | |a Hydrogel | |
| 650 | 4 | |a Inflammation | |
| 650 | 4 | |a Peripheral blood mononuclear cells | |
| 650 | 4 | |a Randomized controlled trial | |
| 650 | 4 | |a Secretome-based therapy | |
| 650 | 4 | |a Skin | |
| 700 | 1 | |a Gouya-Lechner, Ghazaleh |e verfasserin |4 aut | |
| 700 | 1 | |a Hofbauer, Helmut |e verfasserin |4 aut | |
| 700 | 1 | |a Laggner, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Trautinger, Franz |e verfasserin |4 aut | |
| 700 | 1 | |a Almer, Gabriele |e verfasserin |4 aut | |
| 700 | 1 | |a Peterbauer-Scherb, Anja |e verfasserin |4 aut | |
| 700 | 1 | |a Seibold, Marcus |e verfasserin |4 aut | |
| 700 | 1 | |a Hoetzenecker, Wolfram |e verfasserin |4 aut | |
| 700 | 1 | |a Dreschl, Christiane |e verfasserin |4 aut | |
| 700 | 1 | |a Mildner, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Ankersmit, Hendrik Jan |e verfasserin |4 aut | |
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