Stem Cell New Drugs

GXHPC1®

GXHPC1®

GXHPC1® (Liver Cirrhosis)

GXHPC1®
Stem Cell Medicines
A novel autologous adipose-derived stem cell therapy for treating liver cirrhosis, focusing on reducing hepatic inflammation and reversing liver fibrosis.
  • Product

    1. Preclinical

    2. Phase I

    3. Phase II

    4. Phase III

    5. NDA

    6. Marketed

GXHPC1® (Liver Cirrhosis)

Introduction

Introduction

GXHPC1® is a novel, first-in-class autologous adipose-derived stem cell therapy developed for the treatment of liver cirrhosis. Pre-clinical research has demonstrated that GXHPC1® can ameliorate hepatic inflammation and reverse liver fibrosis.

 
In a phase I clinical trial, GXHPC1® through intrahepatic injection (IH) was shown to be safe, with no significant safety issues reported. The results demonstrated that GXHPC1® showed a tendency for improvement of liver function, METAVIR score, Child–Pugh score, MELD score, and quality of life for patients with liver cirrhosis, suggesting its potential as a treatment for liver cirrhosis (Ko-Chang Huang, 2019). Currently, GXHPC1® is undergoing phase II clinical trials (NCT04088058), and the dose is escalated to 200 million cells.

 
Liver cirrhosis has very limited option for treatment at present, with liver transplantation being the only option. However, liver transplantation comes with a low success rate and requires lifelong use of anti-rejection drugs. In contrast, stem cell therapy represents a novel treatment method. GXHPC1® has been confirmed through animal experiments to improve liver fibrosis, promote liver cell regeneration approximately 63%, and enhance liver function indices. These research results have been published in academic journals and have led to the acquisition of invention patents.

Drug Name GXHPC1® 
New Drug Trial Autologous Human Adipose-Derived Stem Cell Transplantation for the Treatment of Cirrhosis
Indication Liver 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.

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 

Instructions
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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.

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

2014

Hsinchu Science Park

 Innovative Product Awards

2014 新竹科學園區創新產品獎

2017

Taipei Biotech Awards

 Innovative Special Mention Award

2017 台北生技獎 優等

2018

15th National Innovation Award

2018 國家新創獎

2019

National Innovation Award

2019 國家新創精進獎

2020

National Innovation Award

2020 國家新創精進獎

2020

National Pharmaceutical Technology

and Research Development Award (NPRDA) - Bronze Award.

2020 藥物科技研究發展獎 銅質獎

2022

National Innovation Award

2022 國家新創精進獎

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