Stempeutics

Knee Osteoarthritis

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

Disease Overview

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 and increasing 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”). 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/maintain cartilage and to stall further disease progression for radiology Grade 2 & Grade 3 Osteoarthritis patients.
knee-pain
OA
Gap in Treatment Options
Current Standard Of Care
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Analgesics
Analgesics are the class of drugs that are used medically by patients to relieve pain without causing a loss of consciousness.
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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.
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Opioid Analgesics
Opioids are substances that act on opioid receptors to produce morphine-like effects.
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Hyaluronan – Intra-Articular HA Therapy
It is thought to replace HA, restore the viscoelastic properties of the synovial fluid, and improve pain and function.
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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
Stempeutics
STEMPEUCEL® OA
Mechanism of Action

Stempeucel® can reduce joint pain via anti-inflammatory effects, and possess chondrogenic differentiation potential In addition, Stempeucel® could provide signal to resident chondro-progenitors of the host to differentiate into chondroblasts and further into chondrocytes, to repair cartilage damage
OA
Manipal Facility
Clinical Trial Design

Randomized, double blind, Phase 3, multi-centric, Placebo controlled study assessing the efficacy & safety of IA administration of stempeucel®
Stempeutics

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

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

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

  • Assessment of biomarkers: CTX – II (urine)
  • Assessment of antibodies: Anti HLA antibody
OUR PROGRESS

Product Development Status

Knee Osteoarthritis
Indication
Basic R&D
Pre-Clinical
Phase 1
Phase 2
Phase 3
Marketing Authorization

Current status of Clinical Trials: All clinical trials are approved by DCGI in India