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| Name | Class |
|---|---|
| Stempeutics Research Malaysia SDN BHD | UNKNOWN |
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This study is designed to know the safety and efficacy of 2 different doses of mesenchymal stem cells in patients suffering from osteoarthritis of knee joint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ex- vivo cultured adult allogeneic MSCs | Experimental | Single intraarticular dose of allogeneic MSCs |
|
| Plasmalyte-A | Placebo Comparator | Single intraarticular dose of 2ml Plasmalyte |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ex- vivo cultured adult allogeneic MSCs | Biological | Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of patients with adverse events as a measure of safety and tolerability |
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score | 1 Year | |
| Change from baseline in WOMAC OA stiffness index | 1 Year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Muhammad Ali Noor Muhd Abdul Ghani, FRCS | KPJ Ampang Puteri Specialist Hospital | Principal Investigator |
| Dr. Ahmad Hisham Abd. Rashid, MD., MS | Clinical Research Centre Hospital Serdang | Principal Investigator |
| Dr. Suntharalingam Subramaniam, FRCS | Pantai Cheras Medical Centre | Principal Investigator |
| Dato' Dr. Ramli Baba, MS | Selayang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pantai Cheras Medical Centre | Kuala Lumpur | Kuala Lumpur | 56100 | Malaysia | ||
| Serdang Hospital |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
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| Plasmalyte-A | Biological | Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan |
|
| Change from baseline in WOMAC OA composite index |
| 1 Year |
| Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain) | 1 Year |
| Change from baseline in radiographic (X-ray) findings of knee | 1 Year |
| Change from baseline in the WORMS score of knee using MRI | 1 Year |
| Change from baseline in arthritis pain scores on the visual analogue scale | 1 Year |
| Reduction in the intake of analgesic tablets from baseline | 1 Year |
| Kuala Lumpur |
| Selangor |
| 43300 |
| Malaysia |
| KPJ Ampang Puteri Specialist Hospital | Kuala Lumpur | Selangor | 68000 | Malaysia |
| Selayang Hospital | Kuala Lumpur | Selangor | 68100 | Malaysia |