LiverClean (Cirrhosis)
Drug Name: LiverClean (Cirrhosis)
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Preclinical
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Phase I Clinical Trials
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Phase II Clinical Trials
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Phase III Clinical Trials
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New Drug Application (NDA) / Regulatory Submission
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Market Launch
Introduce
IntroduceLiver disease includes "hepatitis," "liver fibrosis," "cirrhosis," and "liver cancer." Currently, there is no drug to treat "cirrhosis," and patients can only wait for a liver transplant. Not only does liver transplant surgery have a low success rate, but patients must also take anti-rejection medication long-term after the operation.
In contrast, "stem cell therapy" is a novel treatment approach. The new stem cell drug "GXHPC1清肝淨" has been proven in animal experiments to improve "liver fibrosis," promote liver cell regeneration, and enhance liver function indices. These research results have also been published in academic journals and granted an invention patent.
| Drug Name | GXHPC1 LiverClean | |
| New Drug Trial | Autologous Human Adipose-Derived Stem Cell Transplantation for the Treatment of Cirrhosis | |
| Indication | Chronic Liver Disease and Cirrhosis | |
| Clinical Progress | September 2014 | The Ministry of Health and Welfare approved the Phase I clinical trial. (NCT02297867) |
| January 2018 | The Ministry of Health and Welfare approved the completion of the Phase I clinical trial. | |
| July 2019 | The Ministry of Health and Welfare approved the Phase II clinical trial. (NCT04088058) | |
| 2024 | Expected completion of final patient enrollment | |
| Trial Objective | Phase I Clinical Trial |
To evaluate the safety and suitability of GXHPC1 treatment in patients with cirrhosis. |
| Phase II Clinical Trial |
To evaluate the safety and efficacy of GXHPC1 for treating patients with cirrhosis. | |
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Clinical Trial Collaborating Hospital |
Phase I Clinical Trial |
China Medical University Beigang Hospital |
| Phase II Clinical Trial |
Buddhist Tzu Chi General Hospital | |
| National Taiwan University Hospital (NTUH) | ||
| Taipei City Hospital, Wanfang Branch (Managed by Taipei Medical University) | ||
| Disclosed Information | Center for Drug Evaluation, Taiwan (CDE) | Taiwan Clinical Trials Registry | |
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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.
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Achievements
Achievements| Academic Achievements | ||||
| SCI Journal | Article | |||
| Cell Transplantation | Dec. 2019 | Transplantation with GXHPC1 for Liver Cirrhosis: Phase 1 Trial. | ||
| Cell Transplantation | May. 2017 | Commercial Production of Autologous Stem Cells and Their Therapeutic Potential for Liver Cirrhosis. | ||
| Cell Transplantation | Feb. 2015 | A Proposed Novel Stem Cell Therapy Protocol for Liver Cirrhosis. | ||
| Cell Transplantation | Feb. 2015 | The Antisenescence Effect of Trans-Cinnamaldehyde on Adipose-Derived Stem Cells. | ||
| Journal of Neuroscience and Neuroengineering | Feb. 2013 | Pre-Clinical Studies and Clinical Application of Adipose-Derived Stem Cells. | ||
| Cell Transplantation | Jul. 2012 | Adipose-Derived Stem Cells Can Abrogate Chemical-Induced Liver Fibrosis and Facilitate Recovery of Liver Function. | ||
| Cell Transplantation | Jun. 2010 | Transplantation of Human Wharton’s Jelly-Derived Stem Cells Alleviates Chemically Induced Liver Fibrosis in Rats. | ||
| Life Sciences | Sep. 2009 | Mesenchymal stem cells facilitate recovery from chemically induced liver damage and decrease liver fibrosis. | ||
| Awards and Recognition | ||||
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2014 Hsinchu Science Park Innovative Product Awards |
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2017 Taipei Biotech Awards Innovative Special Mention Award Gwo Xi Stem Cell Applied Technology Co.,Ltd |
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2018年 National Innovation Award |
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2019年 National Innovation Award Innovating and Advancing Award |
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2020年 National Innovation Award Innovating and Advancing Award |
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2020年 Pharmaceutical Technology Research and Development Award - Bronze Award |
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2022年 National Innovation Award Innovating and Advancing Award |
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