Cell and Vector Production Facility for Gene Therapy and Cell Therapy

2016 ◽  
pp. 171-185
Author(s):  
Junichi Mineno
Keyword(s):  
Gene Therapy ◽  
Cell Therapy ◽  
Production Facility

scholarly journals Equitable Access to Gene Therapy: A Call to Action for the American Society of Gene and Cell Therapy

2018 ◽  
Vol 26 (12) ◽  
pp. 2715-2716 ◽  
Author(s):  
Kenneth Cornetta ◽  
Kirtika Patel ◽  
Christopher Mwaniki Wanjiku ◽  
Naftali Busakhala
Keyword(s):  
Gene Therapy ◽  
Cell Therapy ◽  
Equitable Access ◽  
Call To Action ◽  
American Society ◽  
Gene And Cell Therapy

Gene Therapy and Stem Cell Therapy: Overview

2014 ◽  
pp. 1-8
Author(s):  
Aaron L. Magno ◽  
Samuel McLenachan ◽  
Elizabeth P. Rakoczy
Keyword(s):  
Gene Therapy ◽  
Stem Cell ◽  
Cell Therapy ◽  
Stem Cell Therapy

scholarly journals A few ethical issues in translational research for gene and cell therapy

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Luciana Riva ◽  
Carlo Petrini
Keyword(s):  
Gene Therapy ◽  
Cell Therapy ◽  
Translational Research ◽  
Early Phase ◽  
Ethical Issues ◽  
The United States ◽  
Cell Therapies ◽  
Biomedical Technologies ◽  
Regulatory Approach ◽  
Gene And Cell Therapy

Abstract Background Although translational research for drug development can provide patients with valuable therapeutic resources it is not without risk, especially in the early-phase trials that present the highest degree of uncertainty. With the extraordinary evolution of biomedical technologies, a growing number of innovative products based on human cells and gene therapy are being tested and used as drugs. Their use on humans poses several challenges. Methods In this work, we discuss some ethical issues related to gene and cell therapies translational research. We focus on early-phase studies analysing the regulatory approach of Europe and the United States. We report the current recommendations and guidelines of international scientific societies and European and American regulatory authorities. Results The peculiarity of human cell- or tissue-based products and gene therapy has required the development of specific regulatory tools that must be continually updated in line with the progress of the research. The ethics of translational research for these products also requires further considerations, particularly with respect to the specificity of the associated risk profiles. Conclusions An integrated ethical approach that aims for transparency and regulation of development processes, the support of independent judgment in clinical trials and the elimination of unregulated and uncontrolled grey areas of action are necessary to move gene and cell therapy forward.

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