Safety and Efficacy of DT-DEC01 Therapy in Duchenne Muscular Dystrophy Patients: A 12 - Month Follow-Up Study After Systemic Intraosseous Administration.

"Declarations Ethics Approval and Consent to ParticipateThe study was approved by the Bioethics Committee at the Regional Medical Council in Poznan, Poland (approval no. 46/2019). All procedures performed in the study involving human participants were conducted in accordance with the Good Clinical Practice (GCP) guidelines and the ethical standards of 1964 Declaration of Helsinki and its later amendments. Consent to ParticipateFreely-given, informed consent to participate in the study was obtained from all participants (or their parent or legal guardian in the case of children under 16). The tissues were obtained in MedPolonia Hospital (Poznan, Poland). No tissues were obtained from prisoners. Competing InterestsMS is CMO and shareholder of Dystrogen Therapeutics Corp. the company that holds a license for DT-DEC01 therapy. 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). The author declares a potential conflict of interest. KS is CEO and shareholder of Dystrogen Therapeutics Corp. The author declares a potential conflict of interest. GB, AN, JW and JC received fees for work related to this study. AZ, MHS and KB are Dystrogen Therapeutics Corp. employees. Competing Interests MS is CMO and shareholder of Dystrogen Therapeutics Corp. the company that holds a license for DT-DEC01 therapy. 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). The author declares a potential conflict of interest. KS is CEO and shareholder of Dystrogen Therapeutics Corp. The author declares a potential conflict of interest. GB, AN, JW and JC received fees for work related to this study. AZ, MHS and KB are Dystrogen Therapeutics Corp. employees."

"Funding The study was funded by Dystrogen Therapeutics Corp."