Prospective Single Centre, Open Label, Single Arm Clinical Study for Autologous Adipose Tissue Derived ADSCSs in Treatment of Patients With Osteoarthritis

Osteoarthritis (OA) is a degenerative disease that affects the articular cartilage over time and is accompanied by alterations to the synovium, subchondral bone, ligaments, and menisci, as well as hypertrophy of the joint capsule.

Therapies are typically palliative and only alleviate pain in a symptomatic way, failing to stop cartilage degeneration and the following breakdown of other joint structures Therefore, it is crucial for researchers to tackle the challenge of creating OA-modifying therapeutics. The potential of adult mesenchymal stem cells (MSCs) and adipose derived stromal cells fraction also known as stromal vascular fraction has recently being evaluated for chondroprotective efficacy in oa knees.

The present study was taken to evaluate Clinical Effectiveness without any doubt after administration of Non enzymatically processed adipose derived stromal cells along with platelet rich plasma in large number (140 patients) having moderate to severe knee (stage 3 and 4) with objective MRI assessment and 2 year follow up.

Methods

The selection criteria included patients 50 years of age or older with symptomatic primary osteoarthritis of the knee that was defined by daily pain for the previous three months, analgesic use at least once per week, less than 30 minutes of morning stiffness, and a WOMAC score of 75 in the target knee. Grades 3 and 4 kellergen Radiographic Grading Scale of Osteoarthritis were part of the radiographic qualifying requirements. The exclusion criteria included individuals with clinically significant systemic diseases and patients with evidence of secondary knee osteoarthritis or severe osteoarthritis (joint space width-JSW 2 mm).