Stem Cell Therapies: Hype, Hope and Evidence-Based Decisions

Program Overview

Stem cells have captured the imagination of patients, practitioners, scientists, and entrepreneurs worldwide for decades. Widely marketed to the public for their regenerative properties and promise to revolutionize medicine, stem cell therapies often carry claims far exceeding the known benefits. At best, the procedures are largely ineffective; at worst, patients are exposed to severe health complications.

A panel of experts will discuss proven and unproven stem cell interventions and focus on views of the current evidence for clinical use, including what evidence is related to clinical research, how it is obtained, and why it is essential. The panelists include cardiologists, clinical trialists, and members of the FDA to highlight the current clinical and promotional landscape of stem cell-based interventions. The panel will also discuss how the FDA uses and views the evidence in its decision-making and how cell-based interventions are classified to determine whether they require FDA approval.

Joseph G. Rogers, MD (Moderator)
President & Chief Executive Officer
O’Quinn/Willerson Endowed Chair
The Texas Heart Institute ®

Heather Lombardi, PhD
Director, Office of Cellular Therapy and Human Tissues
Office of Therapeutic Products
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

Adrian F. Hernandez, MD, MHS
Duke Health Cardiology Professor
Professor of Medicine
Vice Dean and Executive Director of Duke Clinical Research
Executive Core Faculty Member, Duke-Margolis Center for Health Policy
Member, Duke Clinical Research Institute

Agenda

7:30 am      Reception & Breakfast

8:00 am     Welcome, Kirstin RW Matthews, Ph.D.
Introduction and Moderation: Joseph Rogers, M.D.

8:15             Adrian F. Hernandez, M.D., M.HS., Randomization:  A Gift that Keeps Giving

8:30            Heather Lombardi, PhD, Ethical and Regulatory Challenges Related to Approval of Novel Cell-Based Therapies

8:45            Discussion and Q&A

9:25            Closing Remarks

9:30            Closing

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.

Event Chairs

Keri Sprung
Vice President, Communications & Education
The Texas Heart Institute ®

Kirstin R.W. Matthews, Ph.D.
Fellow in Science and Technology Policy
Lecturer in BioSciences
Center for Health and Biosciences
Rice University’s Baker Institute for Public Policy
Houston, Texas

Emerson C. Perin, M.D., PhD
Medical Director
The Texas Heart Institute ®

REGISTRATION REQUIRED

(Live-streaming available)

OPTIONAL CME (Separate 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 Credits^TM and 1.00 hours of credit.

Registration Link for CME Credits ONLY (Please Register for the Meeting above in addition)

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 Credits^TM. 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.

Registration

Registration fee includes all course materials.

Physicians (MD, DO)                                             $25
Non-Physician*                                                       $25
Fellows/Residents                                                  $25