DNA engineering has advanced very much in recent years. The hybrid of human and animal genes is becoming possible. While the benefit is obvious in pharmaceutical and other area, the ethic issue can not be ignored.
An article "Ethical Implications of Human Genetic Engineering" by Renuka Sivapatham touched all of these ethic issues.
A youtube video titled "Hman Genetic Engineering Legal??? Hybrid World: DNA Modification, Trans-humanism, Transgenic..." talked about this fascinating, but scary topic.
On FDA's side, there are a set of in 'Cellular & Gene Therapy' and in 'Xenotransplantation', for example:
- Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products 2014
Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans 4/3/2003 PHS Guideline on Infectious Disease Issues in Xenotransplantation 1/19/2001 Guidance For Industry: Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans 4/6/1999
FDA also has a Cellular, Tissue, and Gene Therapies Advisory Committee that reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or replacement of tissues for various conditions.
FDA defines the xenotransplantation as "any procedure that involves the transplantation, implantation or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs. The development of xenotransplantation is, in part, driven by the fact that the demand for human organs for clinical transplantation far exceeds the supply."
In EU, EMA this year issued its guideline "Guideline on the quality, non-clinical and clinical aspects5 of gene therapy medicinal products".
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