Ruanshili (for arthritis)
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Drug Name
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Preclinical
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Phase I
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Phase II
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Phase III
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Regulatory Submission
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Launch
Introduce
IntroduceThe primary function of articular cartilage is to reduce friction between bones at the joint surface. Once damaged, articular cartilage is very difficult to repair on its own, which can lead to osteoarthritis (OA). Patients may experience joint pain, tenderness, stiffness, and locking, and even joint effusion.
Pharmacological studies on osteoarthritis by GWOXI's new stem cell drug "GXCPC1 Ruanshili" showed that it can regenerate cartilage tissue. Histological analysis also found newly formed cartilage tissue. In toxicological safety tests, the data showed no tumor formation.
In December 2018, GWOXI and Taipei Veterans General Hospital conducted a Phase I/II human clinical trial. GXCPC1 is expected to become a new stem cell drug for treating arthritis, benefiting more patients suffering from the condition.
| Drug Name | Ruanshili 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. | |
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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 |
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Instructions 2. Go to the [Taiwan Clinical Trials Registry] website. 3. Please enter [GWOXI Stem Cell] in the search field. 4. Then click [Search] to find all of GWOXI's new drug trials.  |
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| 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. | |||
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Awards and Recognition |
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2023 Hsinchu Science Park Innovative Product Award |
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2024 National Pharmaceutical Technology Research and Development Award |
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