Active Post Marketing Surveillance Study to Evaluate the Safety and Effectiveness of StemOneTM in patients with Osteoarthritis (OA) of Knee.

Osteoarthritis (OA) is a chronic degenerative disorder of multifactorial etiology characterized by the loss of articular cartilage, hypertrophy of bone at the margins, subchondral sclerosis and range of biochemical and morphological alterations of the synovial membrane and joint capsule.

It typically involves an entire joint, with the most affected joints being the hips, knees, hands and spine. Common manifestations of osteoarthritis are stiffness and pain. There are a variety of risk factors for osteoarthritis, including high-impact sports, obesity and bone deformities. The prevalence of osteoarthritis increases with obesity and age.

Knee OA is the most leading cause of disability and pain in the adult and old age population. An estimated 10 to 15% of all adults aged over 60 have some degree of OA, with prevalence higher among women than men. Knee OA impairs the physical functions and worsens the quality of life.

Most cases of OA have no known cause and are referred to as primary OA. Primary osteoarthritis is mostly related to aging. It can present as localized, generalized, or as erosive OA. Secondary osteoarthritis is caused by another disease or condition.

This study will include 200 patients administered with StemOneTM in multiple centres across India. The patients will receive an intra-articular injection of StemOneTM (25 million cells in 1ml of CryoStor® CS5 + 1ml PlasmaLyte-A), followed by 2 ml Hyalgan (Sodium Hyaluronate injection). These patients will be followed up for duration of 36 months from the time of administration of StemOneTM.