China's first clinical trial of a new ischemic stroke stem cell imported drug is about to start.
2020-07-15
Cell therapy is a good thing for the benefit of mankind, and it should be encouraged to accelerate development. Whether it is stem cell therapy or somatic cell therapy, we must put the interests of patients first.
On July 6, 2020, Jiuzhitang Metco and Beijing Tiantan Hospital formally signed a clinical trial cooperation agreement, marking that China's first imported stem cell new drug clinical trial is about to start, and the indication is "ischemic stroke". This trial is a phase Ⅰ/Ⅱa clinical trial to evaluate ischemic tolerance human bone marrow mesenchymal stem cells (it-hMSC) in the treatment of sequelae of ischemic stroke. The main investigators are the executive dean of Tiantan Hospital and the National Nervous System Diseases Professor Wang Yongjun, deputy director of the Clinical Medical Research Center and director of the National Center for Neurological Diseases Medical Quality Control. In the trial, subjects will receive a single injection of it-hMSC to evaluate the safety and tolerability of it-hMSC in patients with ischemic stroke. The test population was mainly patients who were clinically diagnosed with ischemic stroke for more than 6 months, needed assistance from others to walk, or were unable to complete ordinary daily activities independently.
1 Stem cells bring new hope to the treatment of stroke
The global mortality rate of stroke is ranked in the top two, and it is the main cause of death of Chinese residents. Ischemic stroke has the characteristics of high morbidity, high morbidity and high mortality. The latest Global Burden of Disease Study (GBD) shows that the overall lifetime risk of stroke in my country is 39.9%, ranking first in the world, which means that about 2 out of every 5 people in Chinese will suffer a stroke.
At present, the treatment of stroke is mainly concentrated in the acute phase. Once more than six months, the rehabilitation effect will obviously decline or stop. In the sequelae period, except for physical therapy, there is almost no medical means to help the patient recover and bring lifelong pain to the patient , Bringing a heavy burden on families and society.
As a special treatment for stroke, stem cells have shown good therapeutic effects. Although there are 16 stem cell drugs on the market worldwide, there are still zero stem cell drugs for the treatment of ischemic stroke. This phase I/IIa clinical trial of stem cell treatment for ischemic stroke is based on the successful completion of the United States and good results, and further in-depth exploration of the therapeutic effect of it-hMSC on ischemic stroke, while unveiling the Chinese stem cell treatment The new chapter of stroke is expected to bring more hope to the majority of patients suffering from stroke.
2Ischemia-tolerant human bone marrow mesenchymal stem cells
The ischemic-tolerant human bone marrow mesenchymal stem cells (it-hMSC) product used in this clinical trial is bone marrow mesenchymal stem cells produced by Stemedica of the United States, which are stem cells extracted from the bone marrow of healthy young adult donors after in vitro expansion Prepared into stem cell medicine. The whole process is cultured under hypoxic conditions, which simulates the real physiological environment of the human body, and the cell performance is better than normal oxygen conditions. The stem cell product has strong proliferative ability, can reduce the damage of hypoxia to tissues, reduce cell apoptosis and inhibit inflammation. In addition, such cells have strong tolerance to ischemic tissues, which can promote the nerve front in ischemic striatum Somatic cells differentiate into neurons, can continuously recruit proliferating cells and improve neurovascular remodeling, and have broad prospects for treating ischemic stroke.
Previously, stem cell products had a very good clinical foundation.
A) In the US
In 2018, the product completed a phase I/IIa clinical trial of human bone marrow mesenchymal stem cells in the treatment of ischemic stroke. The results showed that it-hMSC treatment is safe and patients treated with it-hMSC are in a mental state , Depression, life self-care ability, etc. have achieved significant improvements, and initially proved the effectiveness of stem cell therapy. The results of the trial were published in the international stroke journal Stroke in September 2019.
B) In China
In 2019, Jiuzhitang Metco used this product to carry out the "Preclinical Research on the Treatment of Acute Stroke with Human Bone Marrow Mesenchymal Stem Cells", which received major scientific and technological funding from Beijing.
On February 19, 2020, Jiuzhitang Metco used the product to apply for the stem cell new drug clinical trial application (ie IND) declared by CDE to obtain an implied permission. Prior to Metco IND, the first five approved IND stem cells were all domestically produced. The cell sources included umbilical cord, fat, etc. The indications involved included knee osteoarthritis, diabetic foot ulcers, and graft-versus-host disease. It is the first time in China that a clinical trial of stem cells for the treatment of large indications of the nervous system has been carried out in the form of drug declaration.
3 Progress of clinical trials of stem cells in the treatment of stroke
As a special treatment method for stroke, the good therapeutic effect shown by stem cells has opened up a new treatment approach for cerebrovascular experts.
As of July 2020, there are 89 clinical research projects on stem cells registered on clinicaltrials.gov website for the treatment of stroke (including ischemic stroke and hemorrhagic stroke), including clinical phase Ⅰ and phase Ⅱ. The cell types used are mainly neural stem cells, umbilical cord mesenchymal stem cells, bone marrow mesenchymal stem cells, adipose stem cells, hematopoietic stem cells, etc.
In China, researchers mainly use neural stem cells and mesenchymal stem cells to conduct clinical treatment research on stroke patients, and have made some progress.
In China, the Seventh Medical Center of the General Hospital of the People's Liberation Army launched the "Phase II Clinical Study of Intra-brain Neural Stem Cell Transplantation for the Treatment of Ischemic Stroke and Paralysis."
Peking Union Medical College Hospital carried out "Clinical Research on Neural Stem Cells Intracranial Precision Transplantation for the Treatment of Stroke".
In February 2020, a new stem cell drug for ischemic stroke applied for an implicit permission for clinical trials (acceptance number JXSL1900126). The drug name is "Ischemic Tolerant Human Allogeneic Bone Marrow Mesenchymal Stem Cells."
It should be noted that the launch of the domestic stem cell product IND only indicates that the Food and Drug Administration allows drug applicants to recruit clinical volunteers to conduct clinical trials in cooperative hospitals, and can apply to participate in treatment. However, as with the stem cell clinical research filing project, none of the patients involved should be charged. China's stem cell pharmacy is advancing stumbled. In my country, after the implementation of the new policy on stem cell management (class "dual track system"), 8 clinical trials of stem cell drugs have been approved. Under the guidance of the gradually clear policy and the new vane of industrial development, my country's stem cell clinical transformation will also usher in greater development. Stem cell treatment for ischemic stroke clinical trials, I wish you all the best!
