Recently, the phase I/IIa clinical trial of ischemic stroke treatment (ASSIST), jointly sponsored by Jiuzitang Meike and Beijing Tiantan Hospital, has started to recruit patients.
The drug used in this clinical trial is ischemia-tolerant human allogeneic bone marrow mesenchymal stem cells (it-hMSC), which is registered as an imported drug and classified as a therapeutic biological product.
In 2019, Stemedica has completed a phase I/IIa clinical trial in the U.S. using the same stem cell product for the treatment of ischemic stroke, and the results show that it-hMSC treatment has a good safety profile, and patients treated with it-hMSC Patients treated with it-hMSC showed significant improvements in mental status, depression, and self-care ability, which initially proved the effectiveness of stem cell therapy. The results of the trial were published in September 2019 in Stroke, an international journal specializing in the field of stroke.
On June 28, 2019, Dr. Alex Kharazi, Chief Technical Officer of Stemedica and international stem cell pharmaceutical expert, shared part of the study and results at the “5th Annual Conference of the Chinese Stroke Association and Tiantan International Cerebrovascular Disease Conference”.
On August 24, 2019, Dr. Michael Levy, Professor of Medicine at the University of California, San Diego, and Chief of Pediatric Neurosurgery at Rady Children’s Hospital in San Diego, the principal investigator of a clinical trial of it-hMSC for ischemic stroke in the United States, gave a presentation on “The Role of Stroke in China” at the “3rd China Stroke Basic and Translational Research Summit” hosted by the Chinese Stroke Association. The Role of Mesenchymal Stem Cells in the Treatment of Stroke”. The presentation reviewed the biological characteristics of MSCs and further introduced the biological characteristics of ischemia-tolerant MSCs cultured in hypoxic environment and the resulting advantages for stroke treatment. In addition, these cells are tolerant to ischemic tissues, promote neural precursor cells in ischemic striatum to differentiate into neurons, continuously recruit proliferating cells and improve neurovascular remodeling, which is promising for the treatment of ischemic stroke.
We look forward to the early completion of this clinical trial, which will open up a new avenue for stem cell therapy for cerebrovascular disease.
This clinical trial is now recruiting ischemic stroke patients, please forward to those who need it!
Basic requirements for enrollment.
- male and female ≥ 18 years old.
- a medical history showing that the most recent clinical diagnosis of ischemic stroke was made more than 6 months ago
- MRI findings at first diagnosis and at enrollment suggesting ischemic stroke with functional impairment.
- no substantial improvement in neurological function or functional deficits in the 2 months prior to enrollment in the study
- the presence of severe neurological deficits associated with the diagnoses in 2, such that the subject requires assistance to walk or is unable to perform general activities of daily living independently
- a NIHSS score of 6-20 at the Time of enrollment.
- Life expectancy greater than 12 months.
- the patient has received standard medical care for secondary prevention of ischemic stroke prior to treatment, including but not limited to appropriate blood pressure and cholesterol control measures, use of antiplatelet agents or anticoagulants (except in cases of contraindication)
- be able to understand and provide signed informed consent, or have a designated legal guardian or spouse voluntarily make such decisions on behalf of the subject.
- have a reasonable expectation that the patient will receive standard medical care for secondary prevention of ischemic stroke and attend all planned safety follow-up appointments
- no serious organ dysfunction.
Note: Eligibility for enrollment will be granted only after meeting all requirements and being reviewed by the physicians of this study program. The final right of interpretation rests with the study department.
Who is not suitable to participate in this study?
- history of epilepsy, tumor, brain tumor, traumatic brain injury.
- positive for any of the five hepatitis B surface antigen, e antigen, e antibody and core antibody, positive for hepatitis C virus antibody, positive for syphilis serum antibody or positive for HIV antibody
- a myocardial infarction within 6 months prior to test participation
- have any other clinically significant medical condition or abnormal psychiatric or test results that, in the judgment of the investigator or sponsor, would pose a safety risk to the subject by participating in the trial
- imaging studies suggestive of subarachnoid hemorrhage or intracerebral hemorrhage within the past 12 months
- participation in another study using the trial drug or device within 3 months prior to treatment
- participation in another stem cell therapy-related study.
- history of drug or alcohol abuse in the past year.
- women who are known to be pregnant, breastfeeding or have tested positive for pregnancy (which will be tested during the screening process) or who plan to become pregnant during the trial
- allergy to bovine and pork products.
Planned enrollment: approximately 60
After being screened and eligible and entering the study, you will be provided with study treatment medication and related tests by the sponsor.
Registration: Ms. Sun 13691253809 (Due to the high number of inquiries, you can also add staff WeChat “JZTM-AKER” to submit your registration information online)