GXCPC1® (Knee Osteoarthritis)
Product
Preclinical
Phase I
Phase II
Phase III
NDA
Marketed
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 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. ![]() |
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 |
![]() |
||||
2024 National Pharmaceutical Technology and Research Development Award |
![]() |