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Knee Osteoarthritis - Medical / Health Care - Clinical Services

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Stempeucel® shown anti-inflammatory, immunomodulatory and chondrogenic properties at key stages of development

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OA is one of the most common debilitating diseases experienced within an ageing population and constitutes an urgent medical need. Also obesity, a major risk factor, is increasing in prevalence, occurrence of osteoarthritis. Approximately 30% of the global population over 60 years suffers from OA. The estimated OA population in India alone is approximately 30 million ("mn"). In the United States, OA prevalence is expected to increase by 66 – 100% by 2020. OA largely affects weight bearing joints such as the knee joint & hip joint amongst others. Presently, treatment options available include NSAIDs, glucosamine & chondroitin sulphate, Diacerin (IL – 1 inhibitor), Hyaluronic Acid injections ("HA"), steroid injections, autologous chondrocyte transplantation and, ultimately, total knee replacement. Existing treatment options focus on providing temporary pain relief and reducing inflammation during the early stages of the disease without affecting the course of the disease. Stempeucel® OA has the potential to provide best-in-class pain reduction, improve quality of life, has the potential to regenerate cartilage (data not available) and to stall further disease progression for radiology Grade 2 & Grade 3 Osteoarthritis patients.

Analgesics
Analgesics are the class of drugs that are used medically by patients to relieve pain without causing a loss of consciousness.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
NSAIDs are the most-frequently used drugs to ease the pain, inflammation & stiffness that come with arthritis, bursitis & tendinitis.

Opioid Analgesics
Opioids are substances that act on opioid receptors to produce morphine-like effects.

Hyaluronan – Intra-Articular HA Therapy
It is thought to replace HA, restore the viscoelastic properties of the synovial fluid, and improve pain and function.

Surgical procedures
Surgical treatments for knee OA include arthroscopy, cartilage repair, osteotomy, and knee arthroplasty.

Only symptomatic treatment exists & main objectives of physicians are to control pain adequately, improve function & reduce disability

Primary Efficacy Endpoints

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

Secondary Efficacy End Points

To assess the change from baseline to one year and two years follow-up as compared to the placebo arm in

  • WOMAC OA Pain Index/ Stiffness Index / Physical function Index
  • Patient`s Assessment of Osteoarthritis Pain by VAS
  • MRI imaging (done at baseline, 6, 12 & 24 months) to evaluate:
  • Assess the cartilage quality by T2 mapping
  • Assess the cartilage morphology
  • Assess the cartilage volume
Safety End Points

Assessment of AE(s) + ECG parameters/vital signs

Exploratory End Points
  • Assessment of biomarkers: CTX – II (urine)
  • Assessment of antibodies: Anti HLA antibody

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