A Phase 2 interventional study of Ex- vivo cultured adult allogeneic MSCs and Plasmalyte-A in Osteoarthritis of Knee Joint, sponsored by Stempeutics Research Pvt Ltd. Completed at 4 sites in Malaysia. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by Stempeutics Research Pvt Ltd · Phase 2, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 72 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Stempeutics Research Pvt Ltd is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single intraarticular dose of allogeneic MSCs
Biological: Ex- vivo cultured adult allogeneic MSCs
Single intraarticular dose of 2ml Plasmalyte
Biological: Plasmalyte-A
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
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
Time frame: 1 Year
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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