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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan
Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan
Pantai Cheras Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Serdang Hospital
Kuala Lumpur, Selangor, Malaysia
KPJ Ampang Puteri Specialist Hospital
Kuala Lumpur, Selangor, Malaysia
Selayang Hospital
Kuala Lumpur, Selangor, Malaysia
Number and percentage of patients with adverse events as a measure of safety and tolerability
* Safety evaluation will include assessment of physical examination, periodic monitoring of vital signs (heart rate, respiratory rate, blood pressure and temperature), clinical laboratory investigations (including haematology, serum chemistry, LFT, urine-analysis) and 12-lead ECG recording. * Tolerability: Adverse events monitored using information volunteered by the patients and as observed by the PI will be summarized descriptively by total number of AE(s) and compared between the study arms.
Time frame: 1 year
Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score
Time frame: 1 Year
Change from baseline in WOMAC OA stiffness index
Time frame: 1 Year
Change from baseline in WOMAC OA composite index
Time frame: 1 Year
Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)
Time frame: 1 Year
Change from baseline in radiographic (X-ray) findings of knee
Time frame: 1 Year
Change from baseline in the WORMS score of knee using MRI
Time frame: 1 Year
Change from baseline in arthritis pain scores on the visual analogue scale
Time frame: 1 Year
Reduction in the intake of analgesic tablets from baseline
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Time frame: 1 Year