Stempeutics

Stempeucel® Chronic Low Back Pain

Disease Overview
  • Stempeucel® is a potential candidate for the treatment of chronic low back pain caused by disc degeneration (CLBP). Meant for patients who have exhausted conservative treatment options, may have failed epidural steroid injections and have no further treatment option other than invasive and costly surgical interventions.
  • CLBP is caused by damage to the disc as a result of aging, genetics, and injuries. This compromises the disc’s capacity to act as a fluid-filled cushion between vertebrae and to provide anatomical stability. Damage also causes an inflammatory response with ingrowth of nerves that result in chronic pain. This combination results in CLBP and functional disability.
  • When disc degeneration has progressed to a point that pain and loss of function can no longer be managed by conservative means e.g. medication and physiotherapy, major invasive surgery such as spinal fusion is the only remaining option.
  • Existing therapies treat the symptoms of the disease, but are not disease-modifying and thus do not address the underlying disease cause.
low-back-pain

STEMPEUCEL®

Mechanism of Action of Stempeucel®


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MOA of MSCs in CLBP

  • Anti-inflammatory
  • Anti-apoptotic
  • Anti-pyroptotic
  • Promotion of ECM production
  • Increase in the number of IVD cells (NPC / AFC) due to MSC differentiation
  • Reduced disc tissue degeneration,
  • Recovery of disc height &
  • Decreased pain

Only 27% of patients could return to work after 2 years of fusion surgery




Surgery model: Disc Puncture Model in Sprague Dawley Rat

Major findings:

  • Highest dose tested attenuated the traumatic IVDD-induced allodynia
  • There was marked recovery of gait
  • Recovery in histological features and chrondogenic markers
  • Hence, pre-clinical studies showed evidence of regeneration of the disc after local administration of stempeucel®
  • Plan to go ahead with phase 2 dose finding clinical trial

OUR PROGRESS

Product Development Status

Chronic Low Back Pain
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