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China's first clinical trial using imported stem cells to treat ischemic stroke has officially launched.
2021-01-13
On January 12, 2021, the launch meeting of China's first Phase I/IIa clinical trial (ASSIST) using imported stem cells to treat ischemic stroke, initiated by Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereinafter referred to as "Jiuzhitang Maker"), was successfully held online at the lead unit, Beijing Tiantan Hospital affiliated to Capital Medical University, marking the official start of the clinical trial.
The principal investigator of this clinical trial is Professor Wang Yongjun, president of Beijing Tiantan Hospital affiliated to Capital Medical University. In his speech, President Wang said: "This is the first clinical trial of stem cell treatment for cerebrovascular diseases conducted according to the new version of the Good Clinical Practice (GCP) since the state began regulating stem cells as drugs. This trial is very important for the clinical application of stem cells in cerebrovascular diseases and for changes in the entire management system of stem cell applications."
Project Introduction
This is a multicenter, blinded, randomized, placebo-controlled Phase I/IIa study (ASSIST) evaluating the safety, tolerability, and preliminary efficacy of a single injection of ischemia-tolerant allogeneic human bone marrow mesenchymal stem cells (it-hMSC) in patients with ischemic stroke. The trial will be conducted in two stages. The first stage is an open-label dose-escalation study, and the second stage is a double-blind controlled study. Approximately 60 patients with ischemic stroke will be recruited according to the plan.
Clinical Trial Drug
The it-hMSC product used in this clinical trial is produced by Stemedica Cell Technologies, Inc. (hereinafter referred to as "Stemedica"), which is invested in by the Yonghe Qihang Fund under Jiuzhitang. Stemedica was established in 2005 and obtained a manufacturing license from the California state government in 2010. It has been operating under GMP conditions for more than 10 years and is one of the few companies worldwide capable of producing bone marrow mesenchymal stem cell and neural stem cell products under cGMP conditions. The it-hMSC product produced by Stemedica is cultured entirely under low oxygen conditions simulating the human physiological environment, with performance superior to stem cells cultured under normoxic conditions. Its production process and quality system comply with US FDA and cGMP requirements. This product has obtained 8 IND approvals in the US and was rated as the "best in class" product by Life Technologies (now acquired by Thermo Fisher Scientific).
In 2019, Stemedica completed a Phase I/IIa clinical trial in the US using the same product to treat ischemic stroke. The results showed that it-hMSC treatment was safe, and patients treated with it-hMSC showed significant improvements in mental status, depression levels, and activities of daily living, preliminarily proving the efficacy of stem cell therapy. The trial results were published in September 2019 in the international stroke specialty journal "Stroke."
According to data from the clinicaltrials website, as of January 8, 2021, a total of 75 Phase I, II, and III clinical trials of stem cell therapy for stroke have been conducted worldwide, including 25 in the US, 18 in China (7 in Taiwan), 11 in Europe, 3 in South Korea, 1 in Japan, and 17 in other countries. The clinical trials of Stemedica, invested in by the Yonghe Qihang Fund under Jiuzhitang, are included among them.
In the future, Jiuzhitang Maker will work together with Stemedica to jointly develop stem cell drugs for the treatment of stroke, bringing hope to the many patients suffering from the sequelae of stroke.
Patient Recruitment
Since the disclosure of this clinical trial information, many patients and their families have inquired about detailed information and patient inclusion and exclusion criteria through various means. The following is now announced:
Basic Inclusion Criteria
Male and female aged 18 years or older;
Medical history shows that the most recent clinical diagnosis of ischemic stroke was more than 6 months ago;
MRI results at initial diagnosis and at enrollment indicate ischemic stroke with functional impairment;
No substantial improvement in neurological function or functional deficits in the 2 months prior to enrollment;
Presence of severe neurological impairment related to the diagnosis in item 2, requiring assistance from others to walk or inability to independently perform general daily living activities;
NIHSS score between 6 and 20 at enrollment;
Expected survival greater than 12 months;
Prior to treatment, patients have received standard secondary prevention medical care for ischemic stroke, including but not limited to appropriate blood pressure and cholesterol control measures, and use of antiplatelet or anticoagulant drugs (except where contraindicated);
Able to understand and provide signed informed consent, or have a designated legal guardian or spouse voluntarily make the above decision on behalf of the subject;
Reasonably expect the patient to receive standard secondary prevention medical care for ischemic stroke and participate in all planned safety follow-ups.
No severe organ dysfunction.
Note: Eligibility requires meeting all criteria and approval by the study physician. The final interpretation right belongs to the research department.
Who is not suitable to participate in this study
1. History of epilepsy, tumors, brain tumors, or brain trauma;
2. Positive for any of the five hepatitis B surface antigens, e antigen, e antibody, or core antibody; positive for hepatitis C virus antibody; positive for syphilis serological antibody; or positive for HIV antibody;
3. Myocardial infarction within 6 months prior to participation in the trial;
4. Presence of any other clinically significant medical disease, or abnormal mental or laboratory results, judged by the investigator or sponsor to pose safety risks to the subject if participating in the trial;
5. Imaging shows subarachnoid hemorrhage or intracerebral hemorrhage within the past 12 months;
6. Participation in another study using investigational drugs or devices within 3 months prior to treatment;
7. Previous participation in other stem cell therapy-related studies;
8. History of drug abuse or alcoholism within the past year;
9. Known pregnancy, breastfeeding, positive pregnancy test (to be tested during screening), or planning to become pregnant during the trial;
10. Allergy to beef or pork products.
Planned Recruitment Number
Approximately 60
Note: After screening, if you meet the criteria and are eligible to participate in this study, you will receive the study treatment medication and undergo the necessary related examinations provided by the sponsor.
How to Register
How to register: Teacher Sun, 13691253809
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