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Is expected to 2016 domestic stem cell industry market size will reach one hundred billion yuan

Number of visits: Date:2015-08-26 08:54

Net of medicine of the August 26 news National Health Plan Commission, the State Food and Drug Administration recently jointly issued China's first the stem cells in clinical research management approach ", on stem cells in clinical research institutions qualification and conditions to make the standard, and explicitly prohibits the publication of stem cells in clinical research on advertising, defines a number of measures to protect the subjects of rights and interests. Data show that by 2016, the domestic stem cell industry market size will reach one hundred billion yuan. Insiders believe that, with the management approach, the stem cell industry, especially in the field of treatment will usher in the spring.

Stem cell research is obviously

Stem cell is a kind of multi - potential cell with the ability of self replication, which can be differentiated into many kinds of functional cells under certain conditions. Stem cells as the "seed" cells can be used in cell replacement and tissue regeneration because of the proliferation and differentiation of stem cells. Stem cell research as a key development in the field of Medical Science in recent years, showing a good development prospects, to some difficult diseases of the effective treatment has brought hope, has been widespread concern.

The National Health Planning Commission said that China's "12th Five Year" scientific and technological planning to give a focus on stem cell research, and made gratifying progress. But in the rapid development of stem cell research and transformation, there are also some problems, such as the organization of the high cost of the high cost of stem cells to prepare the standard is not uniform, the quality of the existence of serious problems and other issues, but also because of the lack of effective academic, ethical review and understanding of the situation, so that the interests of subjects can not be guaranteed. Some of the stem cell therapy to evade government regulation, the lack of clinical research data is repeated. To formulate relevant management measures to standardize the clinical research of stem cells, and to protect the rights and interests of the participants.

It is reported that, in addition to the technology has been mature hematopoietic stem cells in the treatment of blood diseases, our country has not approved the use of stem cells to treat other diseases, can only be used for clinical research. Experts have pointed out that China stem cells for clinical treatment of the most significant problems is "immature first hot", were grossly enlarged use.

Hospitals shall not charge fees to patients

The National Health Planning Commission, interpretation of the "management approach", said the "management approach" applies to the stem cell clinical research carried out in the medical institutions, do not apply to the mature technology standards of hematopoietic stem cell transplantation, as well as the clinical trial of stem cells declared.

"Management approach" proposed that medical institutions in accordance with the "management approach" to complete the clinical research of stem cells, not directly into the clinical application; if the application for registration of clinical trials, the clinical research results can be obtained as a technical reporting information submitted and used for drug evaluation. In the course of clinical research, all of the original records of all the records of the stem cell provider and the participants must be accurate, clear and electronic backup, save 30 years after the end of the clinical research. The tracking data of stem cell preparations should be kept for at least 30 years from the date of final disposal.

TypeInfo: Enterprise News

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