STEM CELL THERAPIES:
OPPORTUNITIES FOR ENSURING THE QUALITY AND
SAFETY OF UNREGULATED CLINICAL OFFERINGS
A WORKSHOP
November 18, 2013
National Academy of Sciences Building, Room 125
2101 Constitution Avenue, NW, Washington, DC
Workshop Objectives:
- Discuss the current environment in which patients are receiving unregulated stem cell offerings.
- Examine the stem cell treatments that are being offered.
- Assess the potential benefits and risks to individual health.
- Consider the evidence base needed to substantiate the clinical application of stem cell technologies.
- Evaluate legal hurdles for establishing standards and criteria to govern stem cell trials and treatments.
- Discuss potential solutions for assuring the quality of stem cell offerings.
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8:30 – 8:45 A.M. |
Welcome, Introduction of Moderators, Meeting Goals, and Charge to Participants |
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Alta Charo, Workshop Chair University of Wisconsin–Madison |
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8:45 – 10:20 |
STEM CELL THERAPIES: KNOWNS AND UNKNOWNS |
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Session Moderator: |
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Ralph J. Cicerone National Academy of Sciences |
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8:45 – 9:10 |
Stem Cells as Regulated Therapeutics |
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John Wagner University of Minnesota |
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9:10 – 9:25 |
Clinical Offerings That Use Stem Cells |
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Timothy Caulfield University of Alberta |
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9:25 – 9:40 |
Patients Seeking Unproven or Unregulated Treatments: Why and How |
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Alan Petersen Monash University |
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9:40 – 10:20 |
Moderated Panel Discussion |
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Panelists: John Wagner, Timothy Caulfield, Alan Petersen |
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10:20 – 10:35 |
BREAK |
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10:35 A.M. – 12:30 P.M. |
QUALITY ASSURANCE—PART I |
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Session Moderator |
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Ellen Feigal California Institute for Regenerative Medicine |
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10:35 – 10:50 |
Regulatory and Legal Frameworks for Offering Stem Cell Therapies in the United States |
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Margaret Foster Riley University of Virginia School of Law |
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10:50 – 11:05 |
Regulatory and Legal Frameworks for Offering Stem Cell Therapies in Italy |
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Paolo Bianco Sapienza Universita di Roma |
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11:05 – 11:20 |
Regulatory and Legal Frameworks for Offering Stem Cell Therapies in Japan |
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Toshio Miyata Health and Global Policy Institute |
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11:20 – 11:35 |
Regulatory and Legal Frameworks for Offering Stem Cell Therapies in Mexico |
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María de Jesús Medina Arellano Universidad Autonoma de Nayarit |
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11:35 – 11:50 |
Regulatory and Legal Frameworks for Offering Stem Cell Therapies in China |
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Qi Zhou Institute of Zoology Chinese Academy of Sciences |
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11:50 A.M. – 12:30 P.M. |
Moderated Panel Discussion Panelists: Margaret Foster Riley, Paolo Bianco, Toshio Miyata, María de Jesús Medina Arellano, Qi Zhou |
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12:30 – 2:15 P.M. |
LUNCH SEMINAR |
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12:30 – 12:50 |
BREAK |
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12:50 – 1:00 |
Introductory Comments |
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Irving Weissman Stanford University School of Medicine |
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1:00 – 1:15 |
A Patient’s Story |
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Michael Phelan |
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1:15 – 1:45 |
Medical Tourism: Patients Seeking Stem Cell Treatments I. Glenn Cohen Harvard University Law School |
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1:45 – 2:00 |
Discussion |
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2:00 – 2:15 |
BREAK |
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2:15 – 3:55 |
QUALITY ASSURANCE—PART II |
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Session Moderator |
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Amy Comstock Rick Parkinson’s Action Network |
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2:15 – 2:30 |
Quality of Information: Advertising |
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David Vladeck Georgetown University |
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2:30 – 2:45 |
Quality of Information: ISSCR Statements and Guidelines |
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George Daley Harvard University |
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2:45 – 3:15 |
Quality of Professional Services: Medical and Society-Based Accreditation |
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Professional Society Efforts Calling for Evidence-Based Medicine and Appropriate Independent Oversight |
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Douglas Sipp International Society for Cellular Therapy |
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Professional Society Efforts in Parallel with Government Regulation |
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Glenn L. Schattman Society for Assisted Reproductive Technology |
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3:15 – 3:55 |
Moderated Panel Discussion |
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Panelists: David Vladeck, George Daley, Douglas Sipp, and Glenn L. Schattman |
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3:55 – 4:10 |
BREAK |
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4:10 – 5:10 |
MOVING FORWARD |
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Session Moderator |
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Harvey V. Fineberg Institute of Medicine |
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4:10 – 5:10 |
Moderated Panel Discussion |
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Panelists: Glenn L. Schattman, David Vladeck, María de Jesús Medina Arellano, Timothy Caulfield, Michael Phelan, Gil Van Bokkelen |
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5:10 – 5:25 |
FINAL REMARKS |
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5:10 – 5:25 |
Summary of Salient Points and Final Words |
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Alta Charo University of Wisconsin–Madison Harvey V. Fineberg Institute of Medicine Ralph J. Cicerone National Academy of Sciences |
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5:25 |
ADJOURN |
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