Syiyou (for chronic stroke)
Drug Name
Preclinical
Phase I
Phase II
Phase III
Regulatory Submission
Market Launch
Cerebrovascular disease is one of the top ten leading causes of death in Taiwan, with stroke being the most common. Stroke causes varying degrees of disability, and with no other effective treatments available, patients are often limited to passive rehabilitation. For those with severe conditions who require long-term care, the psychological pressure and financial burden on their caregivers and families undoubtedly make a difficult situation even worse.
Research indicates that stem cells are indeed therapeutic for stroke treatment, highlighting the necessity and urgency of stem cell therapy. GWOXI's new stem cell drug, "GXNPC1 Syiyou," can promote cerebrovascular and nerve regeneration. Confirmed by animal studies, the drug's properties—such as promoting angiogenesis, reducing inflammation, and nerve differentiation—can improve stroke-related disability and enhance coordination, balance, and mobility.
In September 2019, GWOXI collaborated with Hualien Tzu Chi Hospital to initiate a Phase II clinical trial. GXNPC1 is expected to become the first stem cell-based product in Taiwan for the treatment of stroke, offering a new therapeutic option for stroke patients.
Drug Name | Syiyou GXNPC1 | |
Clinical Trial | Autologous Adipose-Derived Stem Cell (ADSC) Brain Transplantation for the Treatment of Chronic Stroke | |
Indication | Chronic Stroke | |
Clinical Progress | December 2014 | The Ministry of Health and Welfare approved the Phase I clinical trial. (NCT02813512) |
December 2018 | The Ministry of Health and Welfare approved the completion of the Phase I clinical trial. | |
September 2019 | The Ministry of Health and Welfare approved the Phase II clinical trial. (NCT04088149) | |
August 2023 | The final patient has completed follow-up, followed by data analysis, data publication, and trial closure. | |
Trial Objective(s) | Phase I Clinical Trial |
To evaluate whether the implantation of autologous adipose-derived stem cells (ADSC), isolated, purified, and expanded in culture, into a stroke lesion using brain stereotactic technology is a safe and suitable treatment for patients with chronic stroke. |
Phase II Clinical Trial |
Primary Objective: To explore the efficacy of GXNPC1 in chronic stroke patients following injection. Secondary Objective: To evaluate the efficacy and safety of GXNPC1 in chronic stroke patients following injection. |
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Clinical Trial Collaborating Hospital |
Phase I Clinical Trial |
Buddhist Tzu Chi General Hospital |
Phase II Clinical Trial |
Buddhist Tzu Chi General Hospital | |
Buddhist Tzu Chi General Hospital | ||
Buddhist Tzu Chi General Hospital | ||
Disclosed Information | Center for Drug Evaluation, Taiwan (CDE) | Taiwan Clinical Trials Registry | |
Instructions 2. Go to the [Taiwan Clinical Trials Registry] website. 3. Please enter [GWOXI Stem Cell] in the search field. 4. Then click [Search] to find all of GWOXI's new drug trials. |
Tzu Chi Da Ai Television's documentary "Guardians of Love as Healers: Reborn" (July 22, 2018)
Discovery Channel - "Taiwan's Incredible Showcase: Biomedical Technology" (October 19, 2020)
nstitute for Biotechnology and Medicine Industry (IBMI): A New Stem Cell Drug for Chronic Stroke – Syiyou | GWOXI Stem Cell Applied Technology (June 2, 2022)
Academic Achievements | ||||
SCI Journal | Article | |||
Journal of tissue engineering and regenerative medicine | Jan. 2022 | Intracerebral transplantation of autologous adipose-derived stem cells for chronic ischemic stroke: A phase I study | ||
Cell Transplantation | Jan. 2016 | Therapeutic Effect of Ligustilide-Stimulated Adipose-Derived Stem Cells in a Mouse Thromboembolic Stroke Model. | ||
Cell Transplantation | Apr. 2014 | The use of ADSCs as a treatment for chronic stroke. | ||
Journal of Neuroscience and Neuroengineering | Feb. 2013 | Pre-Clinical Studies and Clinical Application of Adipose-Derived Stem Cells. | ||
Awards and Recognition | ||||
2018 Hsinchu Science Park Innovative Product Awards |
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2019 Taipei Biotech Awards Innovative Special Mention Award Gwo XiStem Cell Applied Technology Co.,Ltd |
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2019 International Innovation Summit (IIS 2019) International Innovation Award |
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2021年 National Innovation Award |
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2022年 National Pharmaceutical Technology Research and Development Award Bronze Award (Pharmaceutical Category) |
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2022年 National Innovation Award Innovating and Advancing Award |
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2023年 National Innovation Award Innovating and Advancing Award |
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