Stem cell research breaks the ice, hundreds of billions of gold mines beckon!


Release time:

2015-10-27


Recently, the 7th China Medical Biotechnology Forum was held in Hefei. Our reporter learned at the meeting that with the introduction of the ''Management Measures for Stem Cell Clinical Research (Trial) '', related research has gradually lifted the ice, and many projects have reappeared. The industrialization of stem cell research may soon see the dawn before dawn.
The next hundred billion gold mine
"Globally, gene therapy is making important breakthroughs, and many gene therapy studies, including stem cells and tissue engineering, are making a comeback." Wei Yuquan, academician of the Chinese Academy of Sciences and vice president of Sichuan University, pointed out.
Experts at the meeting said that the introduction of the ''Administrative Measures for Stem Cell Clinical Research (Trial) ''and the ''Guiding Principles for Quality Control of Stem Cell Preparations and Preclinical Research (Trial)'' filled the regulatory gap and opened the channel for sequential liberalization. It is possible to transform to application.
The reporter noticed that in late October, the Ministry of Science and Technology announced the results of a major national scientific research plan on stem cell transplantation. The team of Professor Yin Zhengqin from Southwest Hospital of the Third Military Medical University and the team of researcher Zhou Qi from the Institute of Zoology, Chinese Academy of Sciences, innovatively used human embryonic stem cell-derived retinal pigment epithelial cells for transplantation treatment for wet age-related macular degeneration. Various examinations in the ophthalmology of patients after surgery showed that the transplanted cells survived well. "with substantial breakthroughs in the clinical application of stem cells, the stem cell industry will become the next 100 billion gold mine." Attendees prompt.
Homogeneous reality to be solved
At present, China has enterprises in all aspects of the whole industry chain of stem cell collection and storage business, stem cell technology research and development, stem cell transplantation and treatment, but it lags behind the international leading level in the key technologies of stem cell preparation, transformation and application of scientific research achievements. Some enterprises that entered the field in the early years have piled up a large number of stem cell family storage services from umbilical cord blood, umbilical cord, placental peripheral blood and other sources, with uneven technology and serious market homogenization. Excessive non-standard commercial speculation and the business model of "edge ball" have seriously interfered with the normal order of the market.
In recent years, the Ministry of Science and Technology has actively supported stem cell research and incorporated it into the "Twelfth Five-Year" National Strategic Emerging Industry Development Plan and the "Twelfth Five-Year" Development Plan for the Pharmaceutical Industry, 973 plan, 863 plan, and major new drug creation National projects such as the National Natural Science Foundation of China and the Pilot Program of the Chinese Academy of Sciences have all set up the direction of stem cell and regenerative medicine, and industrial funds are also intensively injected.
"The number of stem cell papers published in China ranks second in the world, and a number of research institutions have entered the forefront of international counterparts, but there has been no product market." Wu Zuze, an academician of the Chinese Academy of Sciences and an experimental hematologist, pointed out that the declared research projects carried out in the early years are basically at a standstill, and some projects have been withdrawn.
So far, in addition to hematopoietic stem cells, no other types of stem cell therapy technology or products have been officially approved for clinical application in China.
According to experts at the meeting, there are many reasons for the above situation, including the absence of relevant policies and regulations, the lack of objective and fair evaluation of efficacy, doubts about safety and ethics, the recognition of cell technology needs to be improved, and the high cost of cell therapy.
"The formulation of my country's stem cell medical policy should be based on national conditions, and great efforts should be made to strengthen guidance and supervision to promote the application of stem cell transformation." Wu Zuze suggested that the first is to follow the scientific laws of medical management and put ethical requirements, especially safety, in the first place; the second is to strengthen the guidance and supervision of medical administrative institutions on medical institutions and production enterprises. At the same time, it should be conducive to improving the level of medical technology and promoting the development of science and technology industry.
The core of industrialization is security
"Although many clinical observations are encouraging and new therapeutic areas continue to expand, there are still many safety risks in the clinic of stem cell products due to the lack of sufficient preclinical and clinical data." A meeting of the national drug safety evaluation experts said.
For example, pluripotent stem cells can differentiate and develop into hundreds of different cells and various types of body tissues, which is their medical potential. However, due to the difficulty in determining the precise complexity of stem cell development regulation in the whole process of cell change, it is difficult to accurately predict the effects and adverse reactions of stem cell therapy. In previous animal experiments, undifferentiated embryonic stem cells are prone to teratoma after transplantation; induced pluripotent stem cell progeny have tumors, and the safety of viral vectors used in the induction process also needs to be verified.
"The core issue is safety and effectiveness, and the most basic issue that needs to be resolved is targeting." Wei Yuquan pointed out that these problems are expected to be gradually resolved with the deepening of research.
On the basis of comparing the requirements for applying for new drug clinical trials and applying for clinical research, Wu Zuze said that the requirements for preclinical research data of the two pathways are basically the same. The focus of preclinical research should be on the effectiveness and safety research on the basis of controllable quality; clinical research must have a rigorous design, and multi-center, randomized controlled programs can be used; the evaluation criteria are safe, effective, and superior to existing treatments.
"Major scientific issues and key core technologies such as stem cell regulation and core mechanisms of stem cell therapy still need to be broken through, and a standardized application system of stem cells needs to be established." Experts at the meeting pointed out that more than ten stem cell products have been approved for marketing worldwide, distributed in South Korea, the United States, Canada, Europe, Australia and other countries and regions. It is expected that China can make breakthroughs in research and transformation.
It is also reported that the Industry Development and Policy Research Branch of the China Pharmaceutical Biotechnology Association announced its establishment during the meeting, with a view to promoting industry development, researching policy changes, establishing a bridge between the industry and the government, and promoting the industrialization of scientific research results.