Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research (2014)

8:30 – 8:45 A.M.

Welcome, Introduction of Moderators, Meeting Goals, and Charge to Participants

Alta Charo, Workshop Chair

University of Wisconsin–Madison

8:45 – 10:20

STEM CELL THERAPIES: KNOWNS AND UNKNOWNS

Session Moderator:

Ralph J. Cicerone

National Academy of Sciences

8:45 – 9:10

Stem Cells as Regulated Therapeutics

John Wagner

University of Minnesota

9:10 – 9:25

Clinical Offerings That Use Stem Cells

Timothy Caulfield

University of Alberta

9:25 – 9:40

Patients Seeking Unproven or Unregulated Treatments: Why and How

Alan Petersen

Monash University

9:40 – 10:20

Moderated Panel Discussion

Panelists: John Wagner, Timothy Caulfield, Alan Petersen

10:20 – 10:35

BREAK

10:35 A.M. – 12:30 P.M.

QUALITY ASSURANCE—PART I

Session Moderator

Ellen Feigal

California Institute for Regenerative Medicine

10:35 – 10:50

Regulatory and Legal Frameworks for Offering Stem Cell Therapies in the United States

Margaret Foster Riley

University of Virginia School of Law

10:50 – 11:05

Regulatory and Legal Frameworks for Offering Stem Cell Therapies in Italy

Paolo Bianco

Sapienza Universita di Roma

11:05 – 11:20

Regulatory and Legal Frameworks for Offering Stem Cell Therapies in Japan

Toshio Miyata

Health and Global Policy Institute

11:20 – 11:35

Regulatory and Legal Frameworks for Offering Stem Cell Therapies in Mexico

María de Jesús Medina Arellano

Universidad Autonoma de Nayarit

11:35 – 11:50

Regulatory and Legal Frameworks for Offering Stem Cell Therapies in China

Qi Zhou

Institute of Zoology

Chinese Academy of Sciences

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

12:30 – 2:15 P.M.

LUNCH SEMINAR

12:30 – 12:50

BREAK

12:50 – 1:00

Introductory Comments

Irving Weissman

Stanford University School of Medicine

1:00 – 1:15

A Patient’s Story

Michael Phelan

1:15 – 1:45

Medical Tourism: Patients Seeking Stem Cell Treatments

I. Glenn Cohen

Harvard University Law School

1:45 – 2:00

Discussion

2:00 – 2:15

BREAK

2:15 – 3:55

QUALITY ASSURANCE—PART II

Session Moderator

Amy Comstock Rick

Parkinson’s Action Network

2:15 – 2:30

Quality of Information: Advertising

David Vladeck

Georgetown University

2:30 – 2:45

Quality of Information: ISSCR Statements and Guidelines

George Daley

Harvard University

2:45 – 3:15

Quality of Professional Services: Medical and Society-Based Accreditation

Professional Society Efforts Calling for Evidence-Based Medicine and Appropriate Independent Oversight

Douglas Sipp

International Society for Cellular Therapy

Professional Society Efforts in Parallel with Government Regulation

Glenn L. Schattman

Society for Assisted Reproductive Technology

3:15 – 3:55

Moderated Panel Discussion

Panelists: David Vladeck, George Daley, Douglas Sipp, and Glenn L. Schattman

3:55 – 4:10

BREAK

4:10 – 5:10

MOVING FORWARD

Session Moderator

Harvey V. Fineberg

Institute of Medicine

4:10 – 5:10

Moderated Panel Discussion

Panelists: Glenn L. Schattman, David Vladeck, María de Jesús Medina Arellano, Timothy Caulfield, Michael Phelan, Gil Van Bokkelen

5:10 – 5:25

FINAL REMARKS

5:10 – 5:25

Summary of Salient Points and Final Words

Alta Charo

University of Wisconsin–Madison

Harvey V. Fineberg

Institute of Medicine

Ralph J. Cicerone

National Academy of Sciences

5:25

ADJOURN