ALPHA Study Financial Disclosure
Cedars-Sinai has a financial interest in this study as follows:
- Cedars-Sinai has entered into two licensing agreements with Capricor with respect to intellectual property rights, some of which relate to the drug being tested in this study.
- Cedars-Sinai has received consideration from Capricor pursuant to the two license agreements and may receive additional consideration in the future.
- Cedars-Sinai may be entitled to receive future royalties.
- Cedars-Sinai is a shareholder in Capricor Therapeutics, Inc., the parent company of Capricor.
- Cedars-Sinai receives rent from Capricor in connection with its lease with the sponsor.
Michael Lewis, MD, the principal investigator, is a salaried, faculty employee at Cedars Sinai.
Eduardo Marbán, MD, who is the head of the Cedars Sinai Heart Institute, invented the methods used to grow and expand stem cells from heart biopsies, which are the methods used in the development of the study drug. Cedars-Sinai filed applications for patents regarding those inventions, which have been licensed to Capricor by the sponsor. Eduardo Marbán, MD and his wife, Linda Marbán, PhD, are both founders and shareholders of Capricor. Linda Marbán is the Chief Executive Officer (CEO) of Capricor and also has a part-time position at Cedars-Sinai. Eduardo Marbán, MD, Linda Marbán, PhD, Capricor and the sponsor could benefit financially if the study drug turns out to be commercially viable.
Because of this potential conflict of interest Eduardo Marbán, MD:
- Will disclose financial interest as part of any future publications and/or presentations
- Will not participate in initial recruitment of potential participants
- Will not participate in determinations regarding the severity and relevance of adverse events
- Will not obtain informed consent from potential subjects
- Will not participate in the screening and acceptance of potential research subjects
- Will not perform investigational procedures on enrolled subjects that go beyond clinical assessments completed by a treating physician as part of the ongoing management of a patient
- A non-conflicted investigator will have control over the design and final analysis of the research, and will certify integrity of all aspects of the research, including the eligibility of potential subjects.
- The study will be designed to incorporate measures that minimize potential bias, such as multiple sites, or objective endpoints.
Michael Lewis, MD, Victor Tapson, MD, Antoine Hage, MD, and Timothy Henry, MD, who are the investigators on this study, do not have any financial interest in the study. This means that the investigators will not make or lose money due to the results of the study, whether they are positive or negative.