Release date: 2014-07-25
The history of stem cell therapy has a long history. It has been more than 100 years since the successful application of blood transfusion to save lives and the application of bone marrow transplantation for the treatment of leukemia and other malignant hematological diseases. These are all areas of cell therapy. Due to the advantages of stem cell therapy, the scientific community and the medical community have paid more and more attention to the application, and have provided new therapies and hopes (individualized therapies) for diseases that traditional treatments consider to be "incurable diseases".
1. Stem cell therapy has broad application prospects in cancer and regenerative medicine
Stem cells are a group of primitive cells with self-renewal, high proliferation and multi-directional differentiation potential. They are divided into the following three categories according to their differentiation ability: pluripotent stem cells (ESC), pluripotent stem cells (EPC, MSC), and pluripotent stem cells. According to the source of cells, it is divided into embryonic stem cells and adult stem cells. Due to its ethical nature, embryonic stem cells are currently controversial about its application. At present, adult stem cells are a research hotspot.
1.1 The global application of stem cells is infinite
According to the stem cell industry report "StemCellResearchMarketto2017-GBIResearch2011", in 2001, the global stem cell application market was 330 million US dollars, and in 2004 it was 1 billion US dollars. In 2007, it was close to 2 billion US dollars, with an average annual growth rate of 34%. According to the 2010 Stem Cell Yearbook, the global market for stem cells is expected to reach $400 billion over the next 20 years.
Stem cell therapy can be applied to diseases such as diabetes, leukemia, stroke, Parkinson's and spinal injuries. So far, eight kinds of stem cell drugs have been approved globally. Perhaps most of the current stem cell treatments are individualized medical treatments, which have not yet been standardized and sales are generally available.
Stem cell treatment of diseases must first solve four problems: (1) the source and number of stem cells; (2) the transformation of stem cells into functional cells required by patients; (3) overcoming immune rejection; (4) inducing stem cell formation with certain anatomical structure Organs. It takes a long time to treat diseases with embryonic stem cells. Recently, many research institutions have successfully expanded various tissue stem cells in vitro.
The results of stem cell research can be summarized as two aspects: one is the successful basic research, the most representative induced pluripotent stem cell technology; the other is the clinical application of tissue-derived mesenchymal stem cells (the umbilical cord extracted mesenchyme) Stem cells can not only be an ideal substitute for bone marrow mesenchymal stem cells, but also have a wider range of uses.
The risks of stem cell therapy are: the genetic stability of stem cells injected into the body; the viability of stem cells in patients; the lack of detection of possible abnormalities in embryonic stem cells; stem cells may contain contamination by viruses, prions or other microorganisms; stem cells may produce Cross-transfer and chromosomal interlacing; continuous use of immunosuppressive agents after injection of stem cells; injected stem cells may migrate ectopically and continue to differentiate; genetic stability of stem cells injected into the body.
1.2 National stem cell policies are inconsistent, and multinational companies are arranging
The global stem cell industry policy is inconsistent. Among them, North America and Europe are more active, followed by Asia and Australia.
US policy orientation: The FDA has established a rapid approval channel for stem cell clinical treatment, encouraging clinicians to quickly occupy the commanding heights of stem cell clinical treatment. Obama left the embryonic stem cell research a month after he stepped on the stage. European policy orientation: Germany, Poland, the Czech Republic, Italy and other countries have stricter regulation of stem cells, and human embryos are not allowed to obtain human embryonic stem cells. Sweden, the United Kingdom, and Portugal are more relaxed. French, Irish, Spanish, Norwegian, Finnish, and Romanian Attitude Centers, special legislation for research and research on human embryos.
Asia-Pacific region: Stem cell research and clinical applications occupy a very important position in the world due to a relatively loose or backward regulatory environment. Mainly due to the availability of human embryos and corresponding animal models in research institutions in the Asia-Pacific region, including Korea, Singapore, Australia and China. Japan also plays an important role in related fields due to its strong academic strength and government support.
Multinational companies have increased their investment and have laid out the stem cell industry chain.
1.3 China's stem cell industry is mature upstream, and the middle and lower reaches are the future industrial development direction.
According to the stem cell industry chain, the stem cell sector has formed three major market segments: cord blood bank, new drug screening and cell therapy. Cord blood preservation in the upper reaches of stem cells is currently the most mature and important industrialization project. At present, Zhongyuan Concord and Jinwei Medical have subsidiaries engaged in cord blood stem cell storage business. The former has a umbilical cord blood hematopoietic stem cell bank in Tianjin, and the latter has two cord blood storage business licenses in Beijing and Guangzhou. Umbilical cord blood has become a source of stem cells with a high degree of attention. The Ministry of Health approved the establishment of seven cord blood banks in 2001, and three more in 2002. At present, cord blood storage is only the primary stage of the stem cell industry. Future industrial development projects mainly include genetic diagnostic reagents, gene drugs, stem cell products, and stem cell transplantation.
At present, there is no domestic market for stem cell treatment products in the form of drugs. At present, major cell therapy companies in China are mainly doing cord blood stem cells and mesenchymal stem cells. However, this type of stem cell therapy has not been approved for clinical use in China, and it is not allowed to charge. It is a kind of illegal medical behavior.
As early as the 1960s, China began bone marrow transplantation research; from the late 1970s to the early 1980s, clinical bone marrow transplantation for the treatment of blood diseases continued; since the 1990s, in addition to bone marrow transplantation, peripheral blood and cord blood stem cell transplantation are also common. Used in the treatment of blood diseases and tumors;
Since the 1990s, domestic policies have strongly supported the research and application of stem cells, and it is estimated that there are at least 300 stem cell clinical projects in China. As of July 2012, there are only 7 clinical trials of drug-approved stem cells approved by the CFDA. Others are clinical trials approved by the Food and Drug Administration with Class III medical technology or clinical trials conducted by many domestic medical institutions. .
Since the release of the "Management Methods for Clinical Application of Medical Technology" in March 2009, the Ministry of Health has not approved or approved any stem cell projects related to it for more than three years.
2. China stem cell clinical treatment related companies
2.1 Zhongyuan Concord
Introduction: Holding Tianjin Xiehe Stem Cell Genetic Engineering Co., Ltd., which has the largest cord blood hematopoietic stem cell bank in Asia and a leading domestic stem cell company.
The company's short-term business is based on stem cell storage business and medical testing reagent business.
Stem cell storage business: In 2013, the company's stem cell storage has reached more than 300,000 copies, and nearly 30,000 new storages are added each year. In 2013, the cell test box storage revenue was 280 million yuan, a year-on-year increase of 6%. The stem cell bank has a public library license in Tianjin and Zhejiang, and the self-owned library is built through the form of subsidiaries (the self-organized library is relatively loosely regulated). In the past few years, the company is in the layout stage. The 28 subsidiaries are located in 21 provinces and cities, covering two-thirds of China's territory and three-quarters of the population. It is the most extensive stem cell operation network in China.
Medical testing reagent business: At present, the company uses the existing channels to detect and analyze the genetic information of neonatal stem cells, further increasing the value of stem cell storage and enhancing the potential of clinical application of stem cells. The gene sequence study affecting 37 kinds of tumors and 150 kinds of non-tumor common diseases was carried out. The development of custom microarray for adult tumor risk assessment gene detection and adult common disease risk prediction was also carried out. At the same time, the whole genome analysis technology of oral mucosa was also carried out. Project and sampling technology preparations were completed for people whose genetic business expanded beyond the newborn. Acquisition of Zhicheng Biology, to achieve interoperability between the North and South markets, the future direction of genetic testing will continue to expand, do prenatal testing, Down's screening, etc., to achieve dual-core drive stem cell + gene detection.
Mid-term development of cosmetics beauty care products business and cell preparation business
Beauty and health products business: The company actively invests in the development of beauty and skin care products. Four categories, including Ruier series, mask series, Diana series and Europa legend series, have been researched and put into production, and the products are put into sales channels. The Ruier series also upgrades products according to market feedback. The stage has come to an end, the upgraded product will be put into production soon; the hand cream foot cream series and herbal care series have been completed and will be put into production; maternal series, hand mask film series, moisturizing and nursing products, etc. The series has entered the middle and late stage of research and development; the men's series and the film series (the maintenance of various parts of the body) have completed research and development projects. In combination with its own technological advantages, the company actively prepares human cytokines as a raw material for cosmetic applications.
Cell preparation business: The stem cell drugs developed by the company's subsidiary Tianjin Heze Stem Cell Technology Co., Ltd. have made significant progress. On July 27, 2012, the umbilical cord mesenchymal stem cell anti-liver fibrosis injection developed by Heze Biotech Co., Ltd. was accepted by Tianjin Food and Drug Administration for drug registration (acceptance number: CXSL1200056 Jin). Application for registration of recombinant neomycin (yeast) drug for injection of anti-thrombotic new drugs jointly developed by Beijing Sanyiheze Biotechnology Co., Ltd. and the Institute of Radiation Medicine and Radiation Medicine of the Chinese People's Liberation Army Academy of Military Medical Sciences was obtained in August 2013. The Food and Drug Administration has accepted (acceptance number: CXSL1300060 Army) and passed the on-site inspection in September 2013.
2.2 Jinwei Medical
Jinwei Medical: Currently, under the brand of Daopei Hospital, it manages two of China's largest blood specialist hospitals, as well as the well-known Shanghai Oriental International Hospital, which serves foreign high-end people. In 2013, the newly completed Beijing Qinghe Hospital was put into trial operation, focusing not only on the hematology department, but also on several important departments.
Jinwei Medical is the shareholder of CCBC of China Cord Blood Center. The CCBC business scope and strategic layout of China Cord Blood Center have covered four economically developed eastern coastal provinces of Beijing, Shandong, Zhejiang and Guangdong, and the Chinese cord blood bank is developed. Focused on the mid-to-high-end customer base, the cumulative number of customers was more than 370,000. In 2013, cord blood business income was 720 million Hong Kong dollars, an increase of 11%. At present, Guangdong and Zhejiang Xinku are under construction and are expected to be gradually put into use in the first half of 2015. The market size of Guangdong and Zhejiang is 5-10 times larger than that of the Beijing market, and the market potential is huge.
The company's subsidiary, Cordlife, is the largest stem cell bank operator in Southeast Asia, operating stem cell banks mainly in Hong Kong, Malaysia and Indonesia. The company's 70%-owned Pei Dao Hospital is a private non-established non-hematopoietic stem cell transplant expert Lu Daopei. For-profit hospitals.
2.3 North Branch Bio
Founded in July 2005 and headquartered in Shenzhen, Shenzhen Beike Biotechnology Co., Ltd. is a bio-tech enterprise specializing in basic research of stem cells, clinical application research and stem cell technology services. It has initially established stem cell technology covering the whole country and radiating the whole world. And the service system of related products has formed an integrated stem cell industrialization chain integrating stem cell storage, stem cell detection and identification, stem cell clinical application research, stem cell technology and stem cell product development, stem cell drug screening, stem cell technology communication and talent training.
The total design library of the North Branch Stem Cell Bank has a capacity of nearly 10 million; it stores stem cells from a variety of sources including umbilical cord, fat, bone marrow, placenta, and amnion; the North Branch Stem Cell Bank is the first and only ISO9001 quality control system certification in China. CNAS recognizes the Stem Cell Bank of Qualifications and International Cell Therapy Association (ISCT) membership and has initiated AABB certification to become an AABB member. Beike has established a nationwide clinical application research network and more than 70 cooperative hospitals. Jiangsu, Shenzhen, Anhui and India Cuku have been in operation, and Henan, Liaoning, Heilongjiang and Guizhou libraries have started construction.
Beike has “BEIKECELL stem cell therapy technology†and can target more than 20 indications. Beike Bio has more than 70 stem cell treatment centers in 21 provinces and Southeast Asia. These centers work with local hospitals to provide stem cell clinical treatment to patients. In the past 7 years, the company has accumulated more than 10,000 cases at home and abroad, applied for 14 patents, and has the world's largest mesenchymal stem cell bank, the world's largest channel network for stem cell clinical research and application promotion.
In 2013, the company's stem cell storage has reached more than 300,000 copies, and nearly 30,000 new storages are added each year. In 2013, the cell test box storage revenue was 280 million yuan, a year-on-year increase of 6%. The stem cell bank has a public library license in Tianjin and Zhejiang, and the self-owned library is built through the form of subsidiaries (the self-organized library is relatively loosely regulated). In the past few years, the company is in the layout stage. The 28 subsidiaries are located in 21 provinces and cities, covering two-thirds of China's territory and three-quarters of the population. It is the most extensive stem cell operation network in China.
The three major management systems for cells are expected to be introduced within the year. In March 2013, the “Methods for the Management of Stem Cell Clinical Trials (Trial)â€, “Management Methods for Stem Cell Clinical Trial Research Base (Trial)†and “Guidelines for Quality Control and Preclinical Research of Stem Cell Preparations (Trial)†were issued. ", is expected to release official documents in the second half of the year, which will benefit the industry leader.
Source: Health Care Investors
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