Stempeutics

Diabetic Foot Ulcer


Anti-inflammatory, angiogenic and wound healing properties of MSCs are key to successfully treat patients with DFU

Disease Overview

Diabetes is India's fastest growing disease. About 77 million cases overall, the number is expected to reach 93 million by 2030. Approximately 15% of all Diabetic patients get foot problems - about 15 million. 60% of in-patient admissions in Diabetes are for foot problems and many patients end up with amputation. Only about 24% of wounds heal after 12 weeks of therapy. It has been estimated that every 30 seconds a lower limb is amputated due to the complications of Diabetes.

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Foot
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Manipal Facility
GAP IN TREATMENT OPTIONS
Current Standard Of Care
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Debridement
Debridement should be carried out in all chronic wounds to remove surface debris and necrotic tissues.
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Off-loading
Off-loading of the ulcer area is extremely important for the healing of plantar ulcers.
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Dressings
Ulcers heal more quickly and are often less complicated by infection when in a moist environment.
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Bioengineered Skin Substitutes
Accumulating evidence shows that bioengineered skin substitutes may be a promising therapeutic adjunct therapy to standard wound care.
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MMP Modulators
Matrix metalloproteinases regulate the extracellular matrix components.
The management of DFU remains a major therapeutic challenge which implies an urgent need to review strategies and treatments.
DIABETIC FOOT ULCER

Mechanism of Action

Anti-inflammatory, angiogenic and wound healing properties of MSCs are key to successfully treat patients with DFU

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DFU
Clinical Trial Design

Phase 3 - A Label extension, Randomized, Double Blind, Placebo Controlled, Multicentre, Single Dose, Phase III Study Assessing the Efficacy and Safety of Peri-ulcer Administration of Stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Non-Healing Diabetic Foot Ulcer

  • Proportion of patients with complete healing / closure of the target ulcer at any time during the 12 week treatment period with sustained complete closure for 12 additional weeks of follow-up (Time frame: 12+12= 24 weeks)
  • Rate of reduction in size of the target ulcer

  • Proportion of patients with at least 50% closure of target ulcer during the 24 weeks period
  • Proportion of patients with complete healing / closure of the target ulcer at any time during the 24 week follow up period
OUR PROGRESS

Product Development Status

Diabetic Foot Ulcer
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