Stem Cell New Drugs

GXNPC1®

GXNPC1®

GXNPC1® (Chronic Stroke)

GXNPC1®
Stem Cell Medicines
A novel autologous adipose-derived stem cell therapy for treating chronic stroke, focusing on angiogenesis, neural differentiation, and motor function improvement.
  • Product

    1. Preclinical

    2. Phase I

    3. Phase II

    4. Phase III

    5. NDA

    6. Marketed

GXNPC1® (Chronic Stroke)

Introduction

Introduction

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.

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 [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)

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

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

National Innovation Award

2021 國家新創獎 幹細胞治療慢性腦中風

2022

National Pharmaceutical Technology

and Research Development Award (NPRDA) - Bronze Award.

2022 國家藥物科技研究發展獎 銅質獎

2022

National Innovation Award

2022 國家新創精進獎

2023

National Innovation Award

2023 國家新創精進獎

Back