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Table of Contents
Vol. 110, No. 2, 2008
Issue release date: April 2008
Section title: Review
Cardiology 2008;110:73–80
(DOI:10.1159/000110483)

Similarities and Differences in Design Considerations for Cell Therapy and Pharmacologic Cardiovascular Clinical Trials

Lewis R.M.a · Gordon D.J.b · Poole-Wilson P.A.d · Borer J.S.c · Zannad F.e
aAccess BIO, Boyce, Va., bNational Heart, Lung, and Blood Institute, Washington, D.C., cWeill Medical College of Cornell University, New York, N.Y., USA; dImperial College London, London, UK; eHypertension and Preventive Cardiology Division, Department of Cardiovascular Disease, Centre d’Investigations Cliniques INSERM-CHU, Nancy, France

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Article / Publication Details

First-Page Preview
Abstract of Review

Received: 3/8/2007
Accepted: 3/10/2007
Published online: 10/31/2007
Issue release date: April 2008

Number of Print Pages: 8
Number of Figures: 0
Number of Tables: 2

ISSN: 0008-6312 (Print)
eISSN: 1421-9751 (Online)

For additional information: http://www.karger.com/CRD

Abstract

Cell therapies hold the potential for suppression, modification, or cure of disease. Several unique challenges have been recognized as this field has developed. Many of these involve considerations of trial design. This paper summarizes the discussion and suggestions constructed during the 8th Cardiovascular Clinical Trialists Workshop, a meeting involving cardiovascular clinical trialists, biostatisticians, National Institutes of Health scientists, European and United States regulators, and pharmaceutical industry scientists. Investigators must adapt research methods to accommodate the scientific advances associated with cell therapy. Safety and efficacy of cell therapy for cardiovascular indications should be evaluated with the same degree of scientific rigor required of pharmacologic agents, and the same fundamental regulatory requirements and scientific processes apply to both. Clinical trials for these indications should also meet standards similar to those set for drug therapies. Safety should be determined throughout development, dose responsiveness should be established and, while surrogate endpoints are important development tools, the ultimate demonstration of efficacy must rely on clinical benefit. The establishment of a global safety database for cell therapy would significantly advance the field. Efforts to discover innovative therapies must be balanced by a commitment to comprehensively evaluate the safety and efficacy of the new treatments.

© 2007 S. Karger AG, Basel


  

Author Contacts

Faiez Zannad, MD, PhD, FESC
CIC INSERM CHU
Hôpital Jeanne d’Arc
FR–54200 Toul (France)
Tel. +33 383 65 66 25, Fax +33 383 65 66 19, E-Mail f.zannad@chu-nancy.fr

  

Article Information

The 8th Cardiovascular Clinical Trialists Workshop was supported by an unrestricted educational grant from Pfizer, Inc., New York, N.Y.

Received: March 8, 2007
Accepted: March 10, 2007
Published online: October 31, 2007
Number of Print Pages : 8
Number of Figures : 0, Number of Tables : 2, Number of References : 41

  

Publication Details

Cardiology (International Journal of Cardiovascular Medicine, Surgery, Pathology and Pharmacology)

Vol. 110, No. 2, Year 2008 (Cover Date: April 2008)

Journal Editor: Borer, J.S. (New York, N.Y.)
ISSN: 0008–6312 (Print), eISSN: 1421–9751 (Online)

For additional information: http://www.karger.com/CRD


Article / Publication Details

First-Page Preview
Abstract of Review

Received: 3/8/2007
Accepted: 3/10/2007
Published online: 10/31/2007
Issue release date: April 2008

Number of Print Pages: 8
Number of Figures: 0
Number of Tables: 2

ISSN: 0008-6312 (Print)
eISSN: 1421-9751 (Online)

For additional information: http://www.karger.com/CRD


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