Stem Cell New Drugs

GXCPC1®

GXCPC1®

GXCPC1® (Knee Osteoarthritis)

GXCPC1®
Stem Cell Medicines
An allogeneic adipose-derived stem cell therapy for treating osteoarthritis, focusing on pain relief, cartilage regeneration, and knee function improvement.
  • Product

    1. Preclinical

    2. Phase I

    3. Phase II

    4. Phase III

    5. NDA

    6. Marketed

GXCPC1®(Knee Osteoarthritis)

Introduction

Introduction

Articular cartilage plays a crucial role in reducing friction between bones and joint surfaces. Damage to this cartilage leads to osteoarthritis, resulting in joint pain, tenderness, stiffness, locking, and joint effusion. Gwo Xi Stem Cell Company's new drug, "GXCPC1®" has been shown in pharmacological studies to regenerate cartilage tissue.

 

GXCPC1® is an allogeneic adipose-derived stem cell (ADSC) therapy aimed at treating patients with osteoarthritis (OA). Pre-clinical research has demonstrated that GXCPC1® has significant therapeutic potential for regenerating cartilage, where the histological analysis confirmed the presence of newly formed cartilage tissue, and toxicological safety tests indicated no tumor formation. Clinical trials have progressed through phases I/II, and the results have been published.

 

In the clinical trials, GXCPC1® showed improvements in pain reduction, knee function, and overall tolerance after transplantation. Notably, subjects receiving a high dose of GXCPC1® (4 x 10^7 cells) exhibited significantly better outcomes, including WOMAC total scores, pain, stiffness, function subscales, the visual analog scale (VAS) for pain, and the SF-12 quality of life scale, compared with those in the low dose group (6.7 x 10^6 cells) during a 1 year follow-up (NCT03943576). The trials confirmed that intra-articular injection of ADSCs is safe and well-tolerated, offering a promising therapeutic alternative for treating knee OA.

Drug Name GXCPC1®
Drug Trial Safety and tolerability of allogeneic adipose-derived mesenchymal stem cells (ADSCs) for the treatment of subjects with knee osteoarthritis, accompanied by a Phase II, randomized, single-blind, active-controlled, parallel-group trial for efficacy evaluation.
Indication Knee Osteoarthritis
Clinical Progress December 2018 The Ministry of Health and Welfare approved the Phase I/II clinical trial. (NCT03943576)
October 2022 To apply for the closure of the Phase I/II clinical trial.
July 2023 Publication of statistical results from clinical trial data.
Trial Objective Phase I Clinical Trial  To evaluate the tolerability and safety of GXCPC1 in subjects with knee osteoarthritis.
Phase II Clinical Trial To evaluate the safety and efficacy of treating subjects with knee osteoarthritis with GXCPC1, compared to Hylartin Plus Intra-articular Injection.

Clinical Trial

Collaborating Hospital

Phase I/II Clinical Trial Taipei Veterans General Hospital
Public 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.

台灣藥物臨床試驗資訊網搜尋教學
Academic Achievements
SCI Journal Article
The Knee Dec. 2018 The effect of adipose-derived mesenchymal stem cells and chondrocytes with platelet-rich fibrin releasates augmentation by intra-articular injection on acute osteochondral defects in a rabbit model.
Cell Transplantation Dec. 2023 Safety and tolerability of intra-articular injection of adipose-derived mesenchymal stem cells GXCPC1 in 11 Subjects with knee osteoarthritis: A nonrandomized pilot study without a control arm.

Awards and Recognition

2023

Hsinchu Science Park

Innovative Product Award

2023年創新產品獎

2024

National Pharmaceutical

Technology and Research Development Award

2024年國家藥物科技研究發展獎

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