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| Name | Class |
|---|---|
| Cytopeutics Pte. Ltd. | INDUSTRY |
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Osteoarthritis is a progressively degenerative disease resulting in increasing pain, impairment and ultimately disability. While the available treatments seek to ameliorate pain or improve mobility, these treatments rarely modify the course of the disease, but rather attend to its consequences. For early stage osteoarthritis, treatment is largely limited to addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs). These drugs do not stop the progression of the condition or regenerates damaged cartilage.
This is a randomized and open labelled study aimed to determine the efficacy of intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in patients with mild to moderate osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid | Active Comparator |
| |
| Bone marrow mesenchymal stem cells | Experimental | Autologous bone marrow-derived mesenchymal stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid | Drug | Intra-articular injection; 30mg/2ml; three-weekly injection regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in cartilage thickness at 12 months by MRI | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Score | 1 month, 3 months, 6 months, 9 months, 12 months | |
| IKDC Subjective Knee Evaluation Form (2000) | 1 month, 3 months, 6 months, 9 months, 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ya Mohammad Hassan Shukur, MD | Contact | mhassan@ppukm.ukm.my |
| Name | Affiliation | Role |
|---|---|---|
| Ya Mohammad Hassan Shukur, MD | UKM Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKM Medical Centre | Recruiting | Kuala Lumpur | 56000 | Malaysia |
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| Autologous bone marrow-derived mesenchymal stem cells | Biological | Single intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in hyaluronic acid "Orthovisc" (3rd injection in a three-weekly injection regimen) |
|
| Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray) |
| 12 months |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| C477349 | orthovisc |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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