HOPE-Duchenne (Halt cardiomyOPathy progrEssion in Duchenne)

Exclusion Criteria

• •1. Therapy with intravenous inotropic or vasoactive medications at the time of screening.
• •2. Inability to undergo cardiac catheterization and/or MRI without general anesthesia.
• •3. Immunologic incompatibility with all available Master Cell Banks (MCBs) by single-antigen bead (SAB) serum antibody profiling.
• •4. Planned or likely major surgery in the next 12 months after planned randomization.
• •5. Left Ventricular Assist Devices (LVAD) or those subjects actively in the process of acquiring a LVAD.
• •6. Contraindication to cardiac MRI.
• •7. Known hypersensitivity to contrast agents.
• •8. Estimated glomerular filtration rate (GFR) \<60 mL/min, as calculated by the CKD-EPI cystatin C equation (Inker, Schmid et al. 2012).
• •9. Active infection not responsive to treatment.
• •10. Active systemic allergic reaction(s), connective tissue disease or autoimmune disorder(s).
• •11. History of cardiac tumor or cardiac tumor demonstrated on screening MRI.
• •12. History of previous stem cell therapy.
• •13. History of use of medications listed in Appendix 3 within 3 months prior to signing the Inform Consent Form / Assent through completion of the study infusion.
• •14. Known moderate-to-severe aortic stenosis/insufficiency or severe mitral stenosis/regurgitation.
• •15. Current active alcohol or drug abuse.
• •16. Known history of Human Immunodeficiency Virus (HIV) infection.
• •17. Known history of chronic viral hepatitis.
• •18. Abnormal liver function (alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \>10 times the upper reference range) and/or abnormal hematology (hematocrit \<25%, White Blood Cells \<3000 μl, platelets \<100,000 μl) studies without a reversible, identifiable cause.
• •19. Known hypersensitivity to bovine products.
• •20. Known hypersensitivity to dimethyl sulfoxide (DMSO).
• •21. Uncontrolled diabetes (HbA1c \>9.0).
• •22. Inability to comply with protocol-related procedures, including required study visits.
• •23. Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study.
• •24. Currently receiving investigational treatment on another clinical study or expanded access protocol, including any of the following:
• •* Received investigational intervention within 30 days prior to randomization
• •* Treatment and/or an incomplete follow-up to treatment with any investigational cell based therapy within 6 months prior to randomization
• •* Active participation in other research therapy for cardiovascular repair/regeneration