GXNPC1® (Chronic Stroke)
Product
Preclinical
Phase I
Phase II
Phase III
NDA
Marketed
Stroke is the most common cerebrovascular disease, the leading cause of death in Taiwan, and causes varying degrees of disability. Current treatments are limited to passive rehabilitation and do not provide effective solutions. Severe cases that require long-term care place a huge psychological and financial burden on caregivers and families.
GXNPC1® is a ground breaking autologous adipose stem cell therapy designed to treat chronic stroke. Preclinical studies have shown that GXNPC1® can enhance the expression of homing effect, anti-inflammatory response and angiogenesis. In animal models of ischemic stroke, GXNPC1® showed significant improvements in behavioral tests, including balance beam walking, locomotor activity, and rotation analyses.
In Phase I clinical trials, GXNPC1® was found to be safe, with no adverse events reported. Furthermore, all subjects showed significant improvement six months after transplantation, and the infarction areas in the brains of three treated subjects have shrunk (Tsung-Lang Chiu et al., 2022). GXNPC1® has currently completed phase II clinical trials (NCT04088149). In the clinical trial phase II, the high dose cohort (2 x 10^8 cells) through intracerebral injection showed a dramatic therapeutic response within 3 months after GXNPC1® transplantation, where the NIHSS score improved by an average of 3.0 points in 3 month (8/9 subjects), and continued to improve to 2.7 points until 6 months (5/9 subjects).No serious adverse events (SUSAR) related to GXNPC1® were observed during the phase I and II clinical trials, indicating the safety of GXNPC1® transplantation.
Drug Name | 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 [國璽幹細胞] 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 |
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2019 International Innovation Summit (IIS 2019) International Innovation Award |
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2021 National Innovation Award |
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2022 National Pharmaceutical Technology and Research Development Award (NPRDA) - Bronze Award. |
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2022 National Innovation Award |
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2023 National Innovation Award |
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