The news of Wenhui. com once said, "Macular degeneration, diabetes, Parkinson's disease, spinal cord injury and other diseases are not only difficult problems that plague the medical community, but also bring great pain to patients. Non-stem cell therapy can bring breakthrough treatment progress. "
At present, clinical trials of new stem cell drugs for treating diabetic foot and osteoarthritis in China have been approved, and applications for registration of new stem cell drugs for treating periodontitis such as bone defect caused by chronic periodontitis, graft-versus-host disease and ulcerative colitis have also been accepted by regulatory authorities. At the same time, clinical research on stem cells for treating acute myocardial infarction, cerebral palsy in children, Parkinson's disease, decompensated hepatitis B cirrhosis, macular degeneration, premature ovarian failure and other diseases is also under way.
Compared with previous years, domestic stem cell therapy is developing in a more standardized direction, and it is also moving closer to benefiting mankind.
Research and Development Status of Stem Cell Drugs in China
Since the first international stem cell drug was approved to be listed in 2009, more than ten stem cell drugs have been listed in the world, including acute myocardial infarction, degenerative arthritis, graft-versus-host disease, Crohn's disease, Heller's syndrome and thromboangiitis obliterans. Stem cell drugs have been listed in Europe, the United States, Canada, South Korea and Japan. Cell sources include autologous mesenchymal stem cells and hematopoietic stem cells from different tissues, and there are few allogeneic cells. However, the gap in this field in China still needs to be filled.
List of global stem cell listed products
However, the development of stem cell drugs in China has entered a new stage. China's regulatory framework is gradually improving. The promulgation of "Technical Guiding Principles for the Research and Evaluation of Cell Therapy Products (Trial)" clarified that stem cell therapy is the standard for drug declaration, and at the same time, the new drug approval system of "60-day implied license for clinical trials" provided new development opportunities for the research and development and declaration of new stem cell drugs in China.
According to official website information of Drug Evaluation Center (CDE) of the State Administration of Pharmaceutical Products, since June 20 18, CDE in China has accepted a total of 10 applications for new stem cell drugs, among which four new stem cell drugs, placenta, umbilical cord and allogeneic/autologous adipose-derived mesenchymal stem cells, have obtained clinical tacit approval, and their indications are diabetic foot ulcer, knee osteoarthritis and knee osteoarthritis respectively.
At the same time, the national key project "stem cell and transformation research" is also promoting the research and development of stem cell therapy drugs. For example, one of the assessment objectives pointed out in the Guide to Key Special Applications is to develop cell therapy drugs for a major or rare disease, apply for registration of new stem cell drugs and apply for clinical approval of stem cells. In the new era of policy support and rapid industry development, the gap of stem cell drugs in China is expected to be filled.
At the 47th Understanding the Future Science Lecture, experts from Chinese Academy of Sciences predicted that in the next five to 10 years, there will be official products of stem cell drugs approved by the state on the market.
Mesenchymal stem cell drugs will become a trend.
Mesenchymal stem cells (MSCs) are the most popular in the research and development of stem cell drugs, accounting for a large proportion of all new stem cell drugs. At present, more than half of the more than ten approved stem cell drugs in the world are mesenchymal stem cell therapy products. Four kinds of stem cell drugs that have been clinically approved in China also belong to mesenchymal stem cell therapy products. At present, many stem cell therapies in the clinical research stage in the world also belong to mesenchymal stem cell products, and the number is increasing year by year.
According to the latest research report released by PolarisMarketResearch, the global mesenchymal stem cell market has bright prospects, and the whole market will keep growing under the influence of various comprehensive factors. 20 18-2026, the global mesenchymal stem cell market is expected to grow at a compound annual rate of 7.3%.
Similarly, the report released by ARC shows that the global mesenchymal stem cell market is developing rapidly, with an average growth rate of 6.2%. In 20 18 years, the global market value of mesenchymal stem cells was10.70 billion US dollars, and it is expected to reach 220 million US dollars by the end of 2024. The report points out that the Asia-Pacific region will occupy more market share in the next few years, especially China.
The main factors that promote the growth of mesenchymal stem cells market include the increasing demand for such stem cells in clinic, such as the increasing demand for mesenchymal stem cells as an effective alternative treatment for knee replacement. In addition, the increase in the global elderly population and the rising prevalence of various chronic diseases such as cancer will also promote the market development of mesenchymal stem cells.
Perinatal tissues such as placenta and umbilical cord are rich in mesenchymal stem cells, which are increasingly favored by scientists.
Studies have shown that the proliferation ability of mesenchymal stem cells will decrease with age, and compared with mesenchymal stem cells from bone marrow, fat and other sources, mesenchymal stem cells from perinatal tissues have stronger differentiation potential and immunomodulatory ability, and their immunogenicity is lower.
At present, mesenchymal stem cells derived from perinatal tissues have been used in the treatment and research of many diseases, such as premature aging, systemic lupus erythematosus, Sjogren's syndrome and so on. Up to 20 19, 1 1, more than half of the 62 stem cell clinical research projects in China used mesenchymal stem cells from perinatal tissues. At the same time, two new drugs of peripartum mesenchymal stem cells have obtained clinical approval in China.
prospect
The research and development of stem cells will be a subversive change for human health and life. Stem cells have been widely used to treat degenerative diseases, such as Parkinson's disease, Alzheimer's disease, muscle atrophy caused by aging, cardiovascular diseases, infertility and accidental injuries. With the development of stem cell drugs, the development of human medicine will also enter a new stage-some diseases that have nothing to do in the past are expected to end the clinical dilemma of "no medicine to cure".
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