Wissenschaftliche Evidenz — Axomera®

Die Axomera®-Therapie basiert auf bioelektrischer Geweberegeneration — Anwendung präziser Mikrostromfelder zur Aktivierung körpereigener Reparaturmechanismen. Die mechanistische Grundlage und klinische Erprobung sind in der nachfolgenden Literatur dokumentiert.

Kernstudien

  1. Schröder P, Gaul C, Drabik A, Molsberger A.. Pain localization in cluster headache patients: Onset, peak, and radiation. Acta Neurol. Scand.. 2021. DOI
  2. Molsberger A, McCaig CD.. Percutaneous direct current stimulation – a new electroceutical solution for severe neurological pain and soft tissue injuries. Med. Devices (Auckl.). 2018. DOI
  3. Zhao Z, Watt C, Karystinou A, et al.. Directed migration of human bone marrow mesenchymal stem cells in a physiological DC electric field. Eur. Cell Mater.. 2011. DOI
  4. Zhao M, Song B, Pu J, et al.. Electrical signals control wound healing through PI3Kγ and PTEN. Nature. 2006. DOI
  5. McCaig CD, Rajnicek AM, Song B, Zhao M.. Controlling cell behavior electrically: current views and future potential. Physiol. Rev.. 2005. DOI
  6. Shah JP, Phillips TM, Danoff JV, Gerber LH.. An in vivo microanalytical technique for measuring the local biochemical milieu of human skeletal muscle. J. Appl. Physiol.. 2005. DOI
  7. Song B, Zhao M, Forrester JV, McCaig CD.. Electrical cues regulate orientation and frequency of cell division and wound healing in vivo. PNAS. 2002. DOI
  8. Cheng N, Van Hoof H, Bockx E, et al.. The effects of electric currents on ATP generation, protein synthesis, and membrane transport of rat skin. Clin. Orthop. Relat. Res.. 1982. DOI
  9. Borgens RB, Vanable JW, Jaffe LF.. Bioelectricity and regeneration: initiation of frog limb regeneration by minute currents. J. Exp. Zool.. 1977. DOI
  10. Balasubramanian S, Weston DA, Levin M.. Electroceuticals: emerging applications beyond the nervous system and excitable tissues. Trends Pharmacol. Sci.. 2024. DOI
  11. Avendaño-Coy J, López-Muñoz P, Serrano-Muñoz D, et al.. Electrical microcurrent stimulation therapy for wound healing: A meta-analysis of randomized clinical trials. J. Tissue Viability. 2022. DOI
  12. Konstantinou E, Zagoriti Z, Pyriochou A, Poulas K.. Microcurrent Stimulation Triggers MAPK Signaling and TGF-β1 Release in Fibroblast and Osteoblast-Like Cell Lines. Cells. 2020. DOI
  13. García Naranjo J, Barroso Rosa S, Loro Ferrer JF, et al.. A novel approach in the treatment of acute whiplash syndrome: Ultrasound-guided needle percutaneous electrolysis. A randomized controlled trial. Orthop. Traumatol. Surg. Res.. 2017. DOI
  14. Hoare JI, Rajnicek AM, McCaig CD, et al.. Electric fields are novel determinants of human macrophage functions. J. Leukoc. Biol.. 2016. DOI
  15. Baer ML, Colello RJ.. Endogenous bioelectric fields: A putative regulator of wound repair and regeneration in the central nervous system. Neural Regen. Res.. 2016. DOI
  16. Leppik LP, Froemel D, Slavici A, et al.. Effects of electrical stimulation on rat limb regeneration, a new look at an old model. Sci. Rep.. 2015. DOI
  17. Baer ML, Henderson SC, Colello RJ.. Elucidating the Role of Injury-Induced Electric Fields (EFs) in Regulating the Astrocytic Response to Injury in the Mammalian Central Nervous System. PLoS One. 2015. DOI
  18. Rouabhia M, Park H, Meng S, Derbali H, Zhang Z.. Electrical Stimulation Promotes Wound Healing by Enhancing Dermal Fibroblast Activity and Promoting Myofibroblast Transdifferentiation. PLoS One. 2013. DOI
  19. Balint R, Cassidy NJ, Cartmell SH.. Electrical Stimulation: A Novel Tool for Tissue Engineering. Tissue Eng. Part B Rev.. 2013. DOI
  20. Reid B, Graue-Hernandez EO, Mannis MJ, Zhao M.. Modulating endogenous electric currents in human corneal wounds — a novel approach of bioelectric stimulation without electrodes. Cornea. 2011. DOI
  21. McCaig CD, Song B, Rajnicek AM.. Electrical dimensions in cell science. J. Cell Sci.. 2009. DOI
  22. Shah JP, Danoff JV, Desai MJ, et al.. Biochemicals associated with pain and inflammation are elevated in sites near to and remote from active myofascial trigger points. Arch. Phys. Med. Rehabil.. 2008. DOI
  23. Borgens RB, Jaffe LF, Cohen MJ.. Large and persistent electrical currents enter the transected lamprey spinal cord. PNAS. 1980. DOI

Bibliographie

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Pflichtangaben gemäß § 4 HWG

Axomera® — Medizinprodukt der Klasse IIa nach Verordnung (EU) 2017/745 (MDR). CE-Kennzeichnung CE 0123. Hersteller: be-on-market GmbH, Lilienstrasse 33, D-91244 Reichenschwand. Entwickelt von Columbus Health Products GmbH.

Anwendungsgebiete: Bioelektrische Therapie zur Behandlung muskuloskelettaler Beschwerden, neuropathischer Schmerzen sowie zur Unterstützung von Wund- und Geweberegeneration im Rahmen der zugelassenen Indikationen.

Gegenanzeigen: Aktive elektronische Implantate (z. B. Herzschrittmacher, ICD), Schwangerschaft, akute Infektionen im Behandlungsareal, maligne Tumoren im Behandlungsareal.

Nebenwirkungen: In seltenen Fällen leichte Hautreizung im Elektrodenbereich, vorübergehende Sensibilitätsänderungen oder kurzfristige Schmerzverstärkung möglich.

Zu Risiken und Nebenwirkungen lesen Sie die Gebrauchsanweisung und fragen Sie Ihre Ärztin, Ihren Arzt oder Ihre Apothekerin/Ihren Apotheker.