First clinical trial for imported stem cell treatment for stroke launched at Tiantan Hospital in Beijing

On July 6, 2020, Jiuzhi Tang Meike and Beijing Tiantan Hospital officially signed a clinical trial cooperation agreement, marking China's first import ofstem cellsnew drug clinical trial is about to start, the indications as "ischemicstroke."the trial was a Phase I/II.a clinical trial for the treatment of ischemic stroke sequelae by ischemic lymicsteman stem cell (it-hMSC), with the main researchers being ProfessorWang, executive vice president of Tiantan Hospital, deputy director of the National Center for Clinical Medical Research on Neurological Diseases, and Director of the National Center for Medical Quality Control of Neurological Diseasestrial, subjects were givensingle injection of it-hMSCto assess the safety and tolerance of it-hMSC to patients with ischemic strokeTheof the subject population were mainly clinical
diagnosedpatients who were ischemic strokes for more than 6 months, who needed assistance from others to walk, or who were unable to complete the activities of ordinary daily life independently1 stem cells bring new hope for stroke treatment
the top 2 global fatality rate of stroke , ischemic stroke, the leading cause of death in China's residents, ischemic stroke has high incidence, high disability rate, high mortality rate and so on According to the latest Global Burden of Disease Study, the country's overall lifetime risk of stroke is 39.9 per cent, the highest in the world, meaning that about 2 out of every five people in Chinese will develop stroke in their lifetime At present, the treatment of stroke mainly concentrated in the acute stage, once more than six months, the recovery effect will be significantly reduced or stopped, to the after-effects period, in addition to physical therapy, almost no drug means can help patients recover, to bring lifelong pain to patients, to the family and society brought a heavy burden as a special treatment for stroke, stem cells show good therapeutic effect Although there are 16 stem cell drugs available worldwide, there are zero stem cell drugs for ischemic stroke This clinical trial of ischemic stroke I/IIa in stem cell treatment is based on the successful completion and good results in the United States, to further explore the therapeutic effect of it-hMSC on ischemic stroke, and to open a new chapter in the treatment of stroke in China, hoping to bring more hope to the vast number of patients suffering from stroke 2
Ischemic-tolerant Human Bone Marrow Interstitial Stem Cells ischemic lysis-resistant human bone marrow interstitial stem cell (it-hMSC) products used in this clinical trial are bone marrow interstitial stem cells produced by Stemedica in the United States, and are the stem cells extracted from the bone marrow of healthy young adult donors are prepared into stem cell drugs after in vitro amplification The whole process in the simulation of the real physiological environment of the human body - low oxygen conditions of culture, cell performance is better than normal oxygen conditions The stem cell product proliferation ability is strong, can reduce the damage to tissue seside, reduce apoptosis and inhibit inflammation, in addition, the cell is resistant to ischemic tissue, can promote ischemic striatum in the neuroprecursor cell differentiation to neurons, sustainable recruitment of proliferative cells and improve neuro
vascular reconstruction, the treatment of ischemic stroke prospects Previously, stem cell products have a very good clinical basis 1) in the U.S 2018, the product completed a phase I/IIa clinical trial in the U.S for the treatment of ischemic stroke using human bone marrow-interstitial stem cells, which showed that it-hMSC treatment was safe, and patients treated with it-hMSC achieved significant improvements in mental states, depression, and self-care ability, and initially demonstrated the effectiveness of stem cell therapy The results were published in September 2019 in Stroke, an international stroke journal 2) in China 2019, Jiuzhi Tang Meike used the product to conduct "preclinical research on human bone marrow-to-body hyperplial stem cell treatment for acute stroke" to obtain major special funding from Beijing Science and Technology On February 19, 2020, Kyuchi-Tang Metco obtained an implied license to apply for a clinical trial (i.e IND) for a new stem cell drug declared by CDE using the product Prior to Meco IND, the first 5 approved IND sepsis were made in China, and the cell sources included umbilical cord, fat, etc., involving indications such as knee osteoarthritis, diabetes foot ulcers, transplant anti-host disease, etc For the first time in China, a clinical trial of stem cell treatment of neuropathy was conducted by means of drug declaration 3 the progress of global clinical trials of stroke in stem cell treatment
as a special treatment for stroke, stem cells show good therapeutic effect, to the cerebrovascular experts opened up a new treatment path As of July 2020, there are 89 clinical research projects for stem cell treatment stroke (including ischemic stroke and hemorrhagic stroke) registered on the clinicaltrialtrials.gov website, of which phase I and PHASE II are mainly clinical phases, with cell types mainly used in neural stem cells, umbilical cord interstile stem cells, bone marrow-to-bone- stem cells, fat stem cells, stem cells, and hematopoietic stem cells in China, researchers mainly use neural stem cells and interstitial stem cells for the clinical treatment of stroke patients, and made some progress in China, Professor Xu Ruxiang, of the Seventh Medical Center of the PLA General Hospital (formerly Army General Hospital), team conducted the "Phase II Clinical Study on the Treatment of Ischemic Stroke Paraplegia in Neural Stem Cell Brain Transplant
, Professor Wang Renzhi , of Beijing Concord Hospital, conducted a clinical study on the 's clinical study on the treatment of stroke in the brain of neural stem cells February 2020, a new stem cell drug in ischemic stroke was granted an implicit license for clinical trials (receiving JXSL1900126), with the drug's name being "Ischemic-tolerant Human Heterogeneous Bone Marrow Filling Stem Cells" need to note that the launch of the domestic stem cell product IND only shows that the FDA allows drug declaration enterprises to recruit clinical volunteers in cooperative hospitals to conduct clinical trials, and can apply to participate in treatment However, as in the stem cell clinical research filing project, no fees are allowed to be charged to the patients participating in the study China's stem cell drugization is going on in the same direction In China, 8 clinical trials of stem cell drugs have been approved since the implementation of stem cell management the New Deal (the "two-track system") Under the guidance of the gradual clarity of policy and the new weather vane of industrial development, the clinical transformation of stem cells in China will surely usher in greater development a clinical trial for stem cell treatment for ischemic stroke, wish you all the best! Source: the of the Drug Review Center of the State Food and Drug Administration, , .