Stem Cell New Drugs

GXNPC1

GXNPC1

Syiyou (for chronic stroke)

GXNPC1
Stem Cell-Based Drugs
Autologous Adipose-Derived Stem Cell (ADSC) Brain Transplantation for the Treatment of Chronic Stroke
  • Drug Name

    1. Preclinical

    2. Phase I

    3. Phase II

    4. Phase III

    5. Regulatory Submission

    6. Market Launch

Syiyou (for chronic stroke)

Introduce

Introduce

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.

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
1. Click the [link].

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)

Achievements

Achievements
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

2018 新竹科學園區 創新產品獎

2019 Taipei Biotech Awards

Innovative Special Mention Award

Gwo XiStem Cell Applied Technology Co.,Ltd 

2019 台北生技獎 新創技術獎

2019

International Innovation Summit

 (IIS 2019)

International Innovation Award

2019 國際創新獎

2021年

National Innovation Award

2021 國家新創獎 幹細胞治療慢性腦中風

2022年

National Pharmaceutical Technology Research and Development Award

Bronze Award (Pharmaceutical Category)

2022 國家藥物科技研究發展獎 銅質獎

2022年

National Innovation Award

Innovating and Advancing Award

2022 國家新創精進獎

2023年

National Innovation Award

Innovating and Advancing Award

2023 國家新創精進獎

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