Osteoarthritis (OA) is one of the most common debilitating diseases experienced within an ageing
population and constitutes an urgent medical need. Obesity, a major risk factor, is further
increasing prevalence and occurrence of OA. Approximately 30% of the global population over 60 years
of age, suffers from OA and have no disease modifying treatment options. OA largely affects weight
bearing joints such as the knee joint & hip joint amongst others. Existing treatment options
available include NSAIDs, glucosamine & chondroitin sulphate, Hyaluronic Acid injections (HA),
Diacerin (IL-1 inhibitor), or steroid injections. All of these treatments focus on providing
temporary pain relief and reducing inflammation during early stages of disease without affecting the
course of the disease. All patients ultimately, if able to undergo surgery, will require total knee
replacement.
Our in-licensing partner has developed and obtained marketing authorization
Stem-One
Cell Drug Product for treatment of Grade 2&3 Knee OA patients in India. Results from randomized,
blinded, placebo-controlled trials with single injection of Stempeucel-OA [CTRI/2018/09/015785
(National Institutes of Health and Clinical Trials Registry-India)] demonstrated
statistically
significant
reduction in pain, and improvement in function; (Ref: Am J Sports Med. 2023
Jul;51(9):2254-2266);
with robust quality & thickness of cartilage tissue demonstrating halt in further disease
progression, even at 2 years post-treatment.
Our lead indication is Osteoarthritis of the
knee. We
intend to develop additional products using the pooling technology and enhancements to it for
several additional indications including for example Chronic Limb Ischemia, Diabetic Foot Ulcers,
and Degenerative Disc Disease.
American College of Rheumatology/Arthritis Foundation Guideline - 2019
Stempeucel® is approved by CDSCO (Indian FDA equivalent) for treatment of (1) Grade 2 & 3 Osteoarthritis of the knee in non-obese patients with BMI 30Kg m² (2) No-option CLI due to Bruegers Disease & Artherosclerotic Peripheral Arterial Disease