THI International Symposium on Cardiovascular Regenerative Medicine 2018

October 5-6, 2018

Program Overview

Unlike areas with known evidence-based knowledge, the field of clinical regenerative medicine and stem cell therapy is a nascent field in which most of the competence and performance issues are unestablished. In the current landscape, as this field develops, it is important to share new findings, discuss and debate the state of the field in order to direct further development, and build the framework for its clinical implementation. This meeting provides an important forum for these activities.

The primary need for this educational activity is knowledge based – both the need for knowledge and the application of knowledge to establish successful strategies in clinical regenerative medicine.

To achieve these goals, this symposium includes advanced lectures and dynamic case presentations from experts in each field, as well as the opportunity to interact with leaders in an intimate meeting format.

Join Global Leaders in the Field of Clinical Regenerative Medicine & Stem Cell Therapy

Target Audience

Our audience for this continuing medical education activity includes physicians and researchers. Also, fellows, residents, physician assistants, nurses / nurse practitioners and medical students with an interest in cardiovascular regenerative medicine are encouraged to participate.

Faculty

Roberto Bolli, MD
University of Louisville
Louisville, USA

Kenneth Borow, MD
New York, USA

Stefanie Dimmeler, PhD
The University of Frankfurt
Frankfurt, Germany

Eric Duckers, MD
University of Medical Center
Utrecht, The Netherlands

Francisco Fernandez-Aviles, MD
Hospital General Universitario Gregorio Marañon
Madrid, Spain

Linden A. Green, PhD
Indiana University
Indianapolis, USA

Barry Greenberg, MD
University of California
San Diego, USA

Roger Hajjar, MD
The Mount Sinai Hospital
New York, USA

Joshua Hare, MD
University of Miami
Miami, USA

Timothy Henry, MD
Cedar Sinai,
Los Angeles, USA

Stefan Janssens, MD
KU Leuven
Leuven, Belgium

Andraan Kraaijeveld, MD, PhD
University Medical Center Ultrecht
Utrecht, The Netherlands

Mitchell Krucoff, MD
Duke University School of Medicine
Durham, USA

Dena Ladd
Missouri Cures Education Foundation
St. Louis, USA

Abigail Luo
CBER FDA
USA

W. Robb MacLellan, MD
University of Washington
Seattle, USA

Keith L. March, MD, PhD
University of Florida
Gainesville, USA

James F. Martin, MD, PhD
Baylor College of Medicine
Houston, USA

Philippe Menasche, MD
Hospital George Pompidou
Paris, France

Leslie Miller, MD
University of South Florida College of Medicine
Tampa, USA

Lem Moye, MD, PhD
University of Texas Health Science Center Houston School of Public Health
Houston, USA

Amit Patel, MD
University of Miami Hospital
Miami, USA

Marc Penn, MD
Summa Health,
Akron, USA

Carl Pepine, MD
University of Florida Health
Florida, USA

Emerson C. Perin, MD, PhD*
Texas Heart Institute
Houston, USA

Guilio Pompilio, MD, PhD
Centro Cardiologico Monzino
Milan, Italy

Thomas Povsic, MD
Duke University School of Medicine,
Durham, USA

Ricardo Sanz-Ruiz, MD
Hospital General Universitario Gregorio Maranon
Madrid, Spain

Kirk P. Seward, PhD
Mercator MedSystems
California, USA

Robert Simari, MD
University of Kansas School of Medicine
Kansas City, USA

Doris A. Taylor, PhD*
Texas Heart Institute
Houston, USA

Anthony Ting, PhD
Athersys Inc
Cleveland, USA

Jay Traverse, MD
Minneapolis Heart Institute
Minneapolis, USA

Bojan Vrtovec, MD
University of Medical Center
Ljubljana, Slovenia

Roseann White
Duke University School of Medicine
Durham, USA

James T. Willerson, MD
Texas Heart Institute
Houston, USA

Joseph Wu, MD, PhD
Stanford University
Stanford, USA

Phillip Yang, MD
Stanford University
Stanford, USA

Andres Zeiher, MD
Goethe University
Frankfurt, Germany

 

* Program Directors

Agenda

Friday, October 5, 2018

7:00   Registration/ Continental Breakfast / Exhibits

7:55    WELCOME: Emerson Perin & Doris Taylor (Houston, USA)

OPENING SESSIONChair: James T. Willerson (Houston, USA)

8:00   A Perspective on Clinical Regenerative Medicine: State of Philosophy | Stefan Janssens (Leuven, Belgium)

8:30   Basic Science Perspective on the Future of Regenerative Medicine. What’s Real and What’s Not? | Stefanie Dimmeler (Frankfurt, Germany)

SESSION I: Getting Regenerative Medicine to the Next Level | Chair: Mitchell Krucoff (Durham, USA)

9:00   Review of the Last Meeting and Conclusions. Have We Made Progress? What Do We Have to Do? | Mitchell Krucoff (Durham, USA)

9:10    Collaborating with EMA on Regulatory approvalGiulio Pompilio (Milan, Italy)

9:25    Innovation and CMS, The Other Regulatory Authority  | Roseanne White, DCRI (Durham, USA)

9:40    Collaboration with the FDA on Innovative Data Collection Analysis Methods  | Abigail Luo, CBER (FDA, USA)

9:55     Flexible Trial DesignKen Borow (New York City, USA)

10:10   One States’ Experience with Regenerative Medicine | Dena Ladd (Missouri, USA) 

10:25   Focused Discussion

What is Required to Support a Regulatory Submission in CV Regenerative Medicine 

Moderator: Jonathan Seltzer (Philadelphia, USA)
Timothy Henry (Los Angeles, USA), Thomas Povsic (Durham, USA), Francisco Fernandez- Aviles (Madrid, Spain), Carl Pepine (Gainesville, USA), Roberto Bolli (Louisville, USA), Marc Penn (Akron, USA)


SESSION II:  Addressing 3 Unique Disease States with Cell Therapy | Chair: Thomas Posvic (Durham, USA)

11:00   Refractory Angina: Where Are We Now?Thomas Posvic (Durham, USA)

11:15    Acute MI Revived – Lessons Learned and Ideal Approach Today Giulio Pompilio (Milan, Italy)

11:30   NICMBojan Vrtovec (Ljubljana, Slovenia)

11:45  Speakers and Thomas Posvic, Keith March, Carl Pepine, Jay Traverse, Adriaan Kraaijeveld


12:00pm  Lunch / Exhibits


SESSION III: Heart Failure: Primetime for Cell Therapy | Chair: Ricardo Sanz-Ruiz (Madrid, Spain)

The Big Picture

1:00   Does Heart Failure Need Cell Therapy? Cell Therapy from a HF specialist Point of View  | Barry Greenberg (San Diego, USA)

What is Preventing a Move to a Phase III Trial? Lessons Learned

1:20    IxymyocelAmit Patel (Miami, USA)

1:30    Allstar- What Went Wrong? |  Timothy Henry (Los Angeles, USA)

1:40   SDF-1 A New Chapter | Marc Penn (Akron, USA)

New Studies. New Hope.

1:50    CardiAMP a New ApproachCarl Pepine (Gainesville, USA)

2:00   Using Biospecimens to Drive Personalized Medicine | Doris Taylor (Houston, USA)

2:10   HF: Systemic Therapy to Address the Real Problem – InflammationKeith March (Gainsville, USA)

2:20   ROUNDTABLE: Heart Failure Debrief

“Lessons Learned from Current Development and the Future of Clinical Trials in Cell Therapy”

Moderator: Tim Henry (Los Angeles, USA)
Speakers & Andres Zeiher (Frankfurt, Germany)/ Thomas Povsic (Durham, USA)/ Leslie Miller (Tampa, USA)/ Lem Moye (Houston, USA)/ Bojan Vrtovec (Ljubljana, Slovenia), Roberto Bolli ) Louisville, USA)


2:30   BREAK


SESSION IV:  Unresolved Questions about Delivery | Chair: Giulio Pompilio (Milan, Italy) and Doris Taylor (Houston, USA)

2:45   Targeting of Cell TherapyEmerson Perin (Houston, USA)

2:55   IV Delivery and Spleen Scans | Anthony Ting, PhD (Cleveland, USA) 

3:05    Effective dosage for local delivery – partnering device and therapy | Eric Duckers (San Carlos, USA)

3:15    Real-time MRI Guidance of Intramyocardial Delivery | Adriaan Kraaijeveld (Leuven, Belgium)

3:25  Adventitial Delivery | Kirk Seward (California, USA)

3:35    Repeat Dosing is the Future | Roberto Bolli (Louisville, USA) 

3:45    Critical Analysis of a Repeat Dosing Trial | Bojan Vtrovec (Lubjiana, Slovenia)

3:55    Panel Discussion
Speakers & Timothy Henry, Carl Pepine, Phillip Yang


SESSION V:   Genes and Perspectives | Chair: Doris Taylor (Houston, USA)

4:15  The Future of Regenerative Medicine is through Gene Therapy.  How Do You Keep Going When Everyone Says It Doesn’t Work? | Roger Hajjar (New York, USA) 

4:30   Cardiogenesis through the HIPPO Pathway | James Martin (Houston, USA)


SPECIAL LECTURES I:  Chair: Joshua Hare (Miami, USA)

4:45   If I Had to Do It All Over Again, Perspective form a Pioneer in the Field | Andres Zeiher (Goethe, Germany)

5:00  Progress Towards a Total Biological Heart OR  | Doris Taylor (Houston, USA)

5:15   Adjourn

 

 

Saturday, October 6, 2018

7:30   Registration/ Continental Breakfast / Exhibits

7:55    WELCOME: Emerson Perin & Doris Taylor (Houston, USA)


SESSION VI: Progress of Cell Therapy | Chair: Stefan Janssens (Leuven, Belgium)

8:00   The Future of CCTRN | Robert Simari (Kansas City, USA)  

8:15   Academia vs. Industry. The Role of Venture Capital in the Future of Regenerative Medicine | Marc Penn (Akron, USA)

8:30 The TACTICS effort | Fernando-Francisco Aviles (Madrid, Spain)

8:45   Panel Discussion
Panelist: Speakers & Carl Pepine (Gainesville, USA), Roberto Bolli (Louisville, USA), Phillipe Menasche (Paris, France), Andres Zieher (Frankfurt, Germany), Timothy Henry (Los Angeles, USA)


Special Lectures II

9:00    How Close Are We to Clinical Therapy with iPSC?Joseph Wu (Stanford, USA)

9:20    How Close Are We to Clinical Embryonic Cell Therapy? W. Robb MacLellan, MD (Washington, USA)

9:40    Panel Discussion
Speakers & Doris Taylor (Houston, USA), Leslie Miller (Tampa, USA), Robert Simari (Kansas City, USA), Joshua Hare (Miami, USA), Thomas Povsic (Durham, USA), Roberto Bolli (Louisville, USA)


10:00  Break / Exhibits


SESSION VII:  Adjunctive or Primary Therapy? | Chair: Leslie Milller (Florida, USA)

10:15    Embryonic Derived SC Cell-free Products Phillipe Menasche  (Paris, France)

10:35   Cellular heterogeneity and cardiac repairStefanie Dimmeler (Frankfurt, Germany)

10:55   Beyond iPSC-derived Exosomes: Role of Small moleculse and Cellular Organelles | Phillip Yang (Palo Alto, USA)

11:15    Panel Discussion 
Panelist: Speakers & Carl Pepine (Gainesville, USA)/ Leslie Miller (Tampa, USA)/ Timothy Henry (Los Angeles, USA)/ Jozef Bartunek (Leuven, Belgium)/ Keith March (Indianapolis, USA), Phillip Yang


SESSION VIIINew Applications: PAD and Beyond | Chair: Jay Traverse (Minneapolis, USA)

11:30    AAA Linden Green (Indianapolis, USA)

11:40    PACE 2Emerson Perin (Houston, USA)

11:50    Ex Vivo Cell-based Amelioration of Organ and Tissue Ischemia-reperfusion | Keith March (Indianapolis, USA)

12:00   Panel Discussion: The Future of Cell Therapy
Moderator: Doris Taylor (Houston, USA)
Panelist: Speakers & Roger Hajjar (New York, USA) / Phillipe Menasche (Paris, France)/ Phillip Yang (Stanford, USA)/ Stefan Janssens (Leuven, Belgium), Les Miller (Florida, USA)


12:15     CLOSING REMARKS  | Emerson Perin (Houston, USA) / Doris Taylor (Houston, USA)

12:30    Adjourn

CME Learning Objectives & Credit Designtation

Educational Objectives

  • Summarize the latest developments in clinical cell therapy
  • Evaluate the active participation in the regulatory approval process
  • Determine successful strategies for using the field of regenerative medicine found through new research

Accreditation

Texas Heart Institute is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation

Texas Heart Institute designates this live activity for a maximum of 12.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Travel and Lodging

Meeting Location

The symposium is held in the Texas Heart Institute – The Denton A. Cooley Building located within the Texas Medical Center at 6770 Bertner Avenue, Houston, Texas 77030.

Entrance to the Denton A. Cooley Building is only through the Baylor St. Luke’s Medical Center Bates Street lobby (6720 Bertner Ave.).

The meetings will be held in The Denton A. Cooley auditorium located on the lower level of the Cooley Building which is accessible by the Green Elevators.

Lodging

There are several hotels in the Texas Medical Center within walking distance or short taxi.

Marriott Medical Center  (Group Rate)
6580 Fannin Street
Houston, TX 77030
Phone: 713-796-0080

Hilton Houston Plaza
6633 Travis Street
Houston, TX 77030
Phone: 713-313-4000

Wyndham Hotel & Suites
Houston Medical Center
6800 S. Main Street
Houston TX 77030
Phone: 713-528-7744

Hotel ZAZA
5701 Main Street
Houston, TX 77005
Phone: 713-526-1991

Ground Transportation 

Taxi service to the Texas Medical Center (TMC) hotels from Hobby Airport averages $35 one way. Taxi service from Bush Intercontinental Airport averages $50 one way. Uber & Lyft provide service in Houston. The drive to the TMC is approximately 30 minutes from Hobby Airport and approximately 45 minutes from Bush Intercontinental Airport. Rental car services are also available at both airports.

Parking

Parking for the event is available in Garage 2 located off Holcombe and Bertner for a fee of $13. You may also valet for $14 at the front of Baylor St. Luke’s Medical Center located at 6720 Bertner Avenue.

More information on parking and directions for the Texas Medical Center is available online at www.tmc.edu.