Abstract
Use of the techniques of molecular and cellular biology to treat diseases has begun. More than 222 clinical trials have been initiated in humans1,2; many of these represent preliminary gene-marking trials and Phase I gene-replacement studies in rare and lethal diseases. The application of new somatic cell therapy and gene therapy products to various diseases, including cardiovascular disease, presents many familiar as well as some unique issues that must be addressed. There have been guidelines such as the 1991 Points to Consider for Human Somatic Cell Therapy and Gene Therapy3 as well as the establishment of statutory authority within the United States.4 However, guidelines for extending clinical trials beyond Phase I have not been developed.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
