A clinical trial to evaluate the effects of stem cells in patients with Osteoarthritis of the Knee joint

INTERVENTION: Intervention1: Stempeucel®: stempeucel®‐ Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells suspended in 1 ml CryoStor CS5® + 1 ml PlasmaLyte A. It is a one time injection at baseline. Control Intervention1: Placebo: 2 ml ( 1 ml Cryostor CS5 +1 ml PlasmaLyte A) single dose intraarticular followed by 2 ml hyaluronan. It is a one time injection at baseline. CONDITION: Osteoarthritis of the Knee joint PRIMARY OUTCOME: To assess the change from baseline to one year in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Osteoarthritis Composite Index score as compared to the placebo arm‐‐‐‐‐‐Timepoint: 1 year SECONDARY OUTCOME: To assess the change from baseline to two year in WOMAC ; To assess the change from baseline to one year and two years follow‐up as compared to the placebo arm in ; 1. WOMAC OA Pain Index ; 2. WOMAC OA Stiffness Index ; 3. WOMAC OA Physical Function Index ; Patients Assessment of Osteoarthritis Pain by VAS ; Assess the quality of articular cartilage by T2 mapping ; Cartilage thickness‐MRI ; Cartilage volume‐MRI ; Reduction in intake of analgesics‐‐‐‐‐‐Timepoint: 2 years INCLUSION CRITERIA: 1. Males or females in the age 40 â?? 65 years (both inclusive) 2. History of primary osteoarthritis of the knee characterized by pain which requires intake of analgesics 3. Self‐reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 meters, getting in and out of a chair, getting up from squatting or cross leg position or going up and down stairs 4. Patient on analgesic medication for OA, for 6 weeks based on Investigatorâ??s feedback. 5. Radiological criteria X‐ray knee joint showing radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic criteria (based on site radiologist report). 6. Willing to refrain from any other stem cell treatment for 2 year during the study. 7. Female patients of childbearing age must be willing to use accepted methods of contraception during the co