Europe plans to standardise rules on tissue engineering
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《英国医生杂志》
The European Commission is drafting legislation on tissue engineering to replace the existing patchwork of different national regulations with uniform rules across the European Union.
The initiative is designed to guarantee patient safety and to ensure that tissue engineered products can be marketed without obstacles throughout the European Union to those who need the innovative therapies. It also aims to encourage medical research in an area that can develop new ways of treating diseases by regenerating diseased organs instead of merely repairing them.
Philippe Busquin, the research commissioner, announcing the move, said: "The world of tissue engineering research is rapidly approaching applications that will make a big difference for a broad range of patients. We may be years away from being able to grow replacement organs, but the progress in research has already resulted in the creation of a new commercial biotechnology sector in Europe."
Confirmation of legislation in the pipeline coincides with publication, by the Institute for Prospective Technological Studies at the EU Joint Research Centre in Seville, of the first comprehensive map of the emerging human tissue industry in Europe.
This shows that 113 European companies are active in this field, with 54 involved in in vitro production of tissues. Items developed so far focus on comparatively simple tissues such as skin, cartilage, and bone.
Researchers have not yet developed products with unique lifesaving functions or with clear comparative medical or financial advantages over other forms of treatment. But tissue engineered advances can improve the quality of life through potentially faster and better healing of wounds and less need for repeat surgery.
In the longer term, the industry is confident it can deliver treatment that will improve the speed, extent, and duration of healing compared with existing techniques.
The report confirms that research is currently taking place on products that may provide treatment for cardiovascular diseases (tissue engineered heart valves, vessel grafts, and heart muscle tissue), neurodegenerative diseases, damaged nerve fibres, and spinal cord injury.
In the even more distant future, the industry is looking to construct in vitro human organs to overcome the scarcity of donors for hearts, kidneys, liver, and pancreas.
The EU Joint Research Centre抯 report, Human Tissue-engineered Products: Today抯 Markets and Future Prospects is at www.jrc.es/(Brussels Rory Watson)
The initiative is designed to guarantee patient safety and to ensure that tissue engineered products can be marketed without obstacles throughout the European Union to those who need the innovative therapies. It also aims to encourage medical research in an area that can develop new ways of treating diseases by regenerating diseased organs instead of merely repairing them.
Philippe Busquin, the research commissioner, announcing the move, said: "The world of tissue engineering research is rapidly approaching applications that will make a big difference for a broad range of patients. We may be years away from being able to grow replacement organs, but the progress in research has already resulted in the creation of a new commercial biotechnology sector in Europe."
Confirmation of legislation in the pipeline coincides with publication, by the Institute for Prospective Technological Studies at the EU Joint Research Centre in Seville, of the first comprehensive map of the emerging human tissue industry in Europe.
This shows that 113 European companies are active in this field, with 54 involved in in vitro production of tissues. Items developed so far focus on comparatively simple tissues such as skin, cartilage, and bone.
Researchers have not yet developed products with unique lifesaving functions or with clear comparative medical or financial advantages over other forms of treatment. But tissue engineered advances can improve the quality of life through potentially faster and better healing of wounds and less need for repeat surgery.
In the longer term, the industry is confident it can deliver treatment that will improve the speed, extent, and duration of healing compared with existing techniques.
The report confirms that research is currently taking place on products that may provide treatment for cardiovascular diseases (tissue engineered heart valves, vessel grafts, and heart muscle tissue), neurodegenerative diseases, damaged nerve fibres, and spinal cord injury.
In the even more distant future, the industry is looking to construct in vitro human organs to overcome the scarcity of donors for hearts, kidneys, liver, and pancreas.
The EU Joint Research Centre抯 report, Human Tissue-engineered Products: Today抯 Markets and Future Prospects is at www.jrc.es/(Brussels Rory Watson)