How far is the stem cell drug from us?

Text . . . The outbreak of coVID-19 pneumonia is a serious threat to human health and life safety.
, although China's current new crown epidemic has been effectively controlled, but the international community, especially in the United States, Brazil, India and parts of Africa is raging, showing an explosive growth trend.
the string for epidemic prevention and control is still tight.
to deal with the new crown, the best control strategy is of course "prevention", so vaccine research and development has become the first choice to prevent and control the new crown outbreak.
at present, the global competition for the development of new crown vaccine incentives, China, the United States, the United Kingdom in the first echelon.
recently, the team of academicians of the Academy of Military Medical Sciences Huang Wei recently published the results of the clinical Phase I trial in The Lancet, showing that all 108 volunteers had significant cellular immune response, and the use of safe and well-tolerated, so on April 12, the successful entry into clinical phase II, marking a major step forward in the successful development of the vaccine.
as early as the wuhan epidemic, the Ministry of Science and Technology launched a new coronary pneumonia patients drug treatment research of major scientific and technological projects.
preliminary clinical treatment practices and related clinical studies, interstitial stem cells (MSCs) from neonatal perinatal tissue (umbilical cord, placenta, and amniotic membrane) in particular umbilical cord prosthesis stem cells (UCMSC) show encouraging magical efficacy and safety.
the results of stem cell clinical treatment of more than 200 patients with new crown scored in Wuhan: 1, after the injection of stem cells into the body, the lung lesions show edimen improved and respiratory function improved (see figure 1 below);
can be seen from Figure 1, after THE MSC transplant, chest CT imaging showed that the glass-like turbidity and pneumonia immersion greatly reduced, over-activated immune cells and inflammatory cytokines disappeared.
the above clinical treatment effects and related clinical studies have greatly increased the expectation of accelerating and generally entering clinical use of stem cell products.
However, the most fundamental way to make stem cell products widely and safely used is to turn them into drugs, and to go through the two back-to-back and closely related drug registration approval phases of clinical trial application (IND) and drug marketing license application (NDA).
the United States is the world's most advanced, most concentrated and widely applied country for new drug registration research and development.
in the research and development drugs for the prevention and treatment of new crown pneumonia, the FDA clinically approved six stem cell varieties are under going on to conduct 7 clinical trials, is now basically in The second phase and above and active.
more than half (4) of which were carried out by two pharmaceutical companies, and three were implemented by three well-known medical research institutions, involving a total of five reporting units.
it is worth mentioning that clinical trials in two varieties are progressing rapidly and have reached Phase III (see table 1 below).
generally speaking, if the clinical trial for drug registration approval is going well, Phase I will take about 1 year, Phase II will take about 1 to 2 years, phase III will take about 2 to 3 years, the total will take about 4 to 6 years, with an average of about 5 years, while the NDA phase will generally take about 1 year.
estimates from IND to NDA take about 5 to 7 years, with an average of about 6 years.
is now a special time for the world's new crown epidemic prevention, and the pace of approval is likely to accelerate, given this factor, the stem cell drugs used to prevent new crown pneumonia or ARDS could be available in the United States as soon as next year, later in the year.
, in china, so far no indication of the new crown pneumonia or ARDS stem cell varieties have been registered with the National Drug Trial Center (CDE) registration acceptance, so no relevant clinical trial projects have been approved.
as for stem cell clinical research projects, in accordance with the National Health and Care Commission and the State Drug Administration for the filing of clinical research (referred to as "two committees for the filing"), the current China Clinical Trial Registration Center (ChiCTR) website registered a total of 15 domestic stem cell clinical research projects, the vast majority is still in the exploratory research or pre-trial stage, only 2 studies extended to phase II, of which 1 (ChiCTR200030138) has not been approved by the Committee on Ethics, and 1.
has 13 research units, almost all of which are all of the same, and only one is a research and development enterprise (see table 2).
Although based on the former National Health and Care Commission and the former State Administration of Food and Drug Administration jointly issued on March 20, 2015 ,cell clinical research management measures (trial) (National Health Science and Education (2015) No. 48), "after the development of stem cell clinical research, such as application for drug registration clinical trials, the results of the clinical research obtained as technical declaration information submitted as technical declaration information and used for drug evaluation", but in the current situation, compared with the United States, China to promote stem cell products to the new crown of s
.