GWOXI Stem Cell’s GXCPC1® Receives Approval to Initiate Phase III Clinical Trial in Taiwan for Knee Osteoarthritis
GWOXI Stem Cell’s stem cell medicine, named GXCPC1®, receives Phase III clinical trial approval in Taiwan.
Gwo Xi Stem Cell Applied Technology Co., Ltd., (TPEx: 6704) announced yesterday evening that its stem cell medicine “GXCPC1®”, an allogeneic adipose-derived mesenchymal for the treatment of knee osteoarthritis, has received Phase III clinical trial approval from Taiwan Food and Drug Administration (TFDA) to initiate a Phase III clinical trial. This approval represents an important milestone for the advancement of GXCPC1®.
According to Gwo Xi Stem Cell, GXCPC1® is an allogeneic adipose-derived stem cell therapy that works through dual mechanisms of immunomodulation and cartilage repair. Administered via intra-articular (IA) injection, the product can rapidly relieve pain and improve joint function and without the need for hospitalization or surgery, thereby enhancing patient accessibility.
Clinical data from Phase I/II trials demonstrated that patients experienced significant pain relief within one week of treatment. By week 24, patients achieved a 42.29-point improvement in pain score, indicating a significant improvement in quality of life. Notably, no serious adverse events (SAEs) were reported during the trial.
GXCPC1® has received a Phase III clinical trial approval from the TFDA, representing a key milestone toward in advancing GWOXI’s stem cell therapy product pipeline toward commercialization.
Chairman Dr. Ming-Hsi Chuang stated that GXCPC1® addresses the limitations of traditional autologous cell therapies, which are often time-consuming and costly, by offering an off-the-shelf, scalable product with strong commercial potential. Unlike conventional hyaluronic acid injections that primarily offer symptomatic relief, GXCPC1® can promote tissue regeneration and repair injury area, aiming to deliver longer-lasting and disease-modifying benefits for patients suffering osteoarthritis.
Dr. Chuang also highlighted that GWOXI Stem Cell’s facility at the Hsinchu Biomedical Science Park is designed to produce stem cell therapy products in full compliance with PIC/S GMP standards, supporting both in-house manufacturing and CDMO services. Looking ahead, the company plans to advance its clinical trials, strengthen its patent portfolio, and integrate automated large-scale production with strategic global partnerships to accelerate expansion into the global aging-related healthcare market.
According to Taiwan Ministry of Health and Welfare (MOHW) statistics, osteoarthritis accounts more than 4.01 million outpatient and inpatient visits in Taiwan each year, with annual medical expenditures exceeding NT$6.1 billion. Moreover, the prevalence of knee osteoarthritis is also increasing among younger populations due to increased sports participation and improper exercise habits, highlighting a growing unmet medical need.