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We present first-in-human study assessing safety and efficacy of novel Dystrophin Expressing Chimeric (DEC) cell therapy created by fusion of patient myoblasts with myoblasts of normal donor origin. We report here on safety and functional outcomes of the first 3\u00a0DMD patients<jats:bold>.<\/jats:bold> No study related adverse events (AE) and no serious adverse events (SAE) were observed up to 14\u00a0months after systemic-intraosseous administration of DEC01. Ambulatory patients showed improvements in functional tests (6-Minute Walk Test (6MWT), North Star Ambulatory Assessment (NSAA)) and both, ambulatory and non-ambulatory in PUL, strength and fatigue resistance which correlated with improvement of Electromyography (EMG) parameters. DEC01 therapy does not require immunosuppression, involves no risks of off target mutations, is not dependent upon the causative mutation and is therefore a universal therapy that does not use viral vectors and therefore can be readministered, if needed. This study was approved by the Bioethics Committee (approval\u00a0No. 46\/2019).<\/jats:p>\n                <jats:p><jats:bold>Graphical Abstract<\/jats:bold><\/jats:p>\n                <jats:p>Mechanism of action of the Dystrophin Expressing Chimeric Cell (DEC) cells created via ex vivo fusion of human myoblast from normal and DMD-affected donors. Following systemic-intraosseous administration, DEC engraft and fuse with the myoblasts of DMD patients, deliver dystrophin and improve muscle strength and function. 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The author declares a potential conflict of interest. MS is the inventor on the patent application filed by University of Illinois at Chicago related to chimeric cell therapy for Duchenne muscular dystrophy (WO\/2016\/201182). KS is CEO and shareholder of Dystrogen Therapeutics Corp. AH is the adviser to Dystrogen Therapeutics Corp. The authors declare a\u00a0potential conflict of interest. GB, JW, JC and AN received fees for work related to this study. AZ, MHS and KB are Dystrogen Therapeutics Corp. employees. SGT declares no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"All procedures performed in the study involving human participants were in accordance with the ethical standards of the 1964 Helsinki Declaration and its later amendments and the Good Clinical Practice (GCP) guidelines. The study was approved by the Bioethics Committee at the Regional Medical Council in Poznan, Poland (approval\u00a0No. 46\/2019).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Freely-given, informed consent to participate in the study was obtained from all participants (or\u00a0their parent or legal guardian in the case of children under 16). The tissues were obtained in\u00a0MedPolonia Hospital (Poznan, Poland). No tissues were obtained from prisoners.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Freely-given, informed consent to publish their data in journal article was obtained from all participants (or their parent or legal guardian in the case of children under 16).","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}