The tremendous potential of stem cells to treat a wide range of diseases has captured the imaginations of patients, practitioners, scientists and entrepreneurs worldwide for decades. However, despite being widely marketed to the public for their regenerative properties and their promise to revolutionize medicine, stem cell therapies often carry claims that far exceed the known benefits. At best, the procedures are largely ineffective, and at worst, patients are exposed to severe health complications.
At this event, expert panelists discussed proven and unproven stem cell interventions with a focus on the current evidence for clinical use, including what evidence is related to clinical research, how it is obtained and why it is essential. Panelists also highlighted the current clinical and promotional landscape of stem cell-based interventions and how the FDA uses and views the evidence in its decision-making. Lastly, they discussed how stem cell-based interventions are classified to determine whether they require FDA approval.
This event is part of an annual policy lecture series co-sponsored by the Baker Institute Center for Health and Biosciences and the Texas Heart Institute. Support for the program has been provided by a grant from the George and Mary Josephine Hamman Foundation.
Agenda
7:30 am — Breakfast
8:00 am — Presentation
Registration
Registration has closed.
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Participants
Welcome
Kirstin R.W. Matthews, Ph.D.
Fellow in Science and Technology Policy, Baker Institute
Featured Speakers
Adrian F. Hernandez, M.D., M.HS.
Executive Director, Duke Clinical Research Institute; Vice Dean, Duke University School of Medicine
Heather Lombardi, Ph.D.
Director, Office of Cellular Therapy and Human Tissues, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
Moderator
Joseph G. Rogers, M.D.
President and Chief Executive Officer, Texas Heart Institute
CME (Pre-registration Required)
Pre-register in The Texas Heart Institute My CME Portal to receive the follow-up survey to earn 1.50 AMA PRA Category 1 CreditsTM and 1.00 hour of credit. Registration Link.
Accreditation: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The Texas Heart Institute and Rice University’s Baker Institute. The Texas Heart Institute is accredited by the ACCME to provide continuing medical education for physicians.
Credit Designation: Texas Heart Institute designates this live activity for a maximum of 1.50 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Ethics: This activity has been designated by The Texas Heart Institute for 1.00 hours of education in medical ethics and/or professional responsibility.
CME Registration: CME Registration fee includes all course materials.
Physicians (MD, DO) — $25
Non-Physician* — $25
Fellows/Residents — $25
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