Ability to provide written informed consent in accordance with federal, local, and institutional guidelines SAFETY RUN-IN: Signed written informed consent in accordance with regulatory and institutional guidelines RANDOMIZED PHASE II CLINICAL TRIAL: Signed written informed consent in accordance with regulatory and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Informed and must sign and give written informed consent in accordance with institutional and federal guidelines Written informed consent in accordance with federal, local, and institutional guidelines DONOR: Documented informed consent per local, state and federal guidelines Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. However, the Investigator should not repeat procedures that are performed as part of standard of care (SOC), if they are within the screening window and are done prior to signing the informed consent form (ICF) Signed informed consent form in accordance with institutional and federal law policies Written informed consent in accordance with federal, local, and institutional guidelines Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines. Recipient must have signed a voluntary, informed consent in accordance with institutional and federal guidelines Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines Subjects must sign a written informed consent in accordance with institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Signed written informed consent per institutional and federal regulatory requirements Written informed consent in accordance with institutional guidelines. Signed, written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Ability to provide written informed consent in accordance with federal, local, and institutional guidelines Signed informed consent in accordance with federal, local, and institutional guidelines Signed, written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Signed written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines; the patient must provide informed consent prior to the first screening procedure Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with federal, local, and institutional guidelines. Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent following institutional and federal guidelines Written informed consent in accordance with federal, local, and institutional guidelines Written informed consent in accordance with institutional guidelines Ability to provide written informed consent in accordance with federal, local, and institutional guidelines Be capable of signing and providing written consent in accordance with institutional and federal guidelines Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines