Ethical Issues in Molecular Medicine and Gene Therapy

2003 ◽  
pp. 319-346
Author(s):  
Leonard M. Fleck
Keyword(s):  
Gene Therapy ◽  
Ethical Issues ◽  
Molecular Medicine

Ethics of First-in-Human Transplantation Trials of Bioartificial Organs

2021 ◽  
Vol 66 (Special Issue) ◽  
pp. 62-63
Author(s):  
Dide de Jongh ◽  
◽  
Eline Bunnik ◽  
Emma Massey ◽  
◽  
...  
Keyword(s):  
Gene Therapy ◽  
Clinical Trials ◽  
Regenerative Medicine ◽  
Ethical Issues ◽  
Artificial Organs ◽  
Diabetic Patients ◽  
Bioartificial Organs ◽  
Deceased Donors ◽  
Cell And Gene Therapy

"The most effective treatment for type 1 diabetes is transplantation of either a whole pancreas from a deceased donor or islet cells derived from multiple deceased donors. However, transplantation has several limitations, including shortage of post-mortem donors and the need for post-transplant patients to use life-long immunosuppressive medication. In the last decade, the field of regenerative medicine has combined engineering and biological technologies in the attempt to regenerate organs. The European VANGUARD project aims to develop immune-protected bioartificial pancreases for transplantation into non-immunosuppressed type 1 diabetic patients. This project is creating a ‘combination product’ using cells and tissue from a variety of sources, including placentas and deceased donors. The clinical development of this complex product raises ethical questions for first-in-human (FIH) clinical trials. Under what conditions can bio-artificial organs safely are transplanted in humans for the first time? How can patients be selected, recruited and informed responsibly? In this presentation, we investigate the ethical conditions for clinical trials of bio-engineered organs, focusing inter alia on study design, subject selection, risk-benefit assessment, and informed consent. We present the results of a review of the literature on the ethics of clinical trials in regenerative medicine, cell and gene therapy and transplantation, and specify existing ethical guidance in the context of FIH transplantation trials of bioartificial organs. We conclude that this new and innovative area at the intersection of regenerative medicine, cell and gene therapy and transplantation requires adequate consideration of the ethical issues in order to guide responsible research and clinical implementation. "

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.

Scientific, Logistical, and Ethical Issues Related to Creation of a Stem Cell Repository for Use in Experimental Trials of Gene Therapy for AIDS

1997 ◽  
Vol 13 (11) ◽  
pp. 905-907
Author(s):  
JOHN K. FRASER ◽  
JEREMY SUGARMAN ◽  
PAUL R. McCURDY ◽  
NATASHA L. MARTIN ◽  
ARTHUR J. AMMANN
Keyword(s):  
Gene Therapy ◽  
Stem Cell ◽  
Ethical Issues ◽  
Experimental Trials

Molecular medicine. One less hoop for gene therapy

Science ◽  
1994 ◽  
Vol 265 (5172) ◽  
pp. 599-599 ◽  
Author(s):  
E Marshall
Keyword(s):  
Gene Therapy ◽  
Molecular Medicine

Gene Therapy: Socioeconomic and Ethical Issues A Roundtable Discussion

1996 ◽  
Vol 7 (9) ◽  
pp. 1139-1144 ◽  
Author(s):  
Alan L. Hillman ◽  
Malcolm K. Brenner ◽  
Arthur L. Caplan ◽  
John Carey ◽  
Yves Champey ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Ethical Issues ◽  
Roundtable Discussion
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