This trial is planed to study if allogeneic mesenchymal stem cells would be safe and beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of stem cells will be used in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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
Department of Orthopedics, M. S. Ramaiah Memorial Hospital
Bangalore, Karnataka, India
Department of Orthopedics, Kasturba Medical College
Manipal, Karnataka, India
Seth G. S. Medical College and KEM Hospital
Mumbai, Maharashtra, India
Jehangir Hospital
Pune, Maharashtra, India
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: 2 years
Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score
Time frame: 2 years
Change from baseline in WOMAC OA stiffness index
Time frame: 2 years
Change from baseline in WOMAC OA composite index
Time frame: 2 years
Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)
Time frame: 2 years
Change from baseline in radiographic (X-ray) findings of knee
Time frame: 2 years
Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI
Time frame: 2 years
Change from baseline in arthritis pain scores on the visual analogue scale
Time frame: 2 years
Reduction in the intake of analgesic tablets from baseline
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Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Time frame: 2 years