Pre-Clinical Safety of Stempeucel® – Safety & Efficiency Proven
Stempeucel® Features
- Multipotent (multilineage differentiation – adipogenesis, osteogenesis, chondrogenesis)
- Immunosuppressive (inhibition of lymphocyte proliferation, no short-term or long-term effects on lymphocyte profile)
- Effective engraftment to the defect site without localizing to other organs
Pre-Clinical Safety
- No side effect observed.
- Non-toxic, non-teratogenic and non-tumorigenic for single and multiple administration of Stempeucel® at various doses through intravenous or intramuscular routes.
- No prenatal toxicity observed in pregnant model.
- No tumour formation observed in severe combined immunodeficient model.
- A death occurs one day after high dose intravenous administration of Stempeucel®. However, no treatment-related gross pathological and histopathological changes were observed. This proves that the death is unrelated to the product.
Overview of Safety in Non-Atherosclerotic Critical Limb Ischemia
- Single and multiple administration of Stempeucel® is safe.
- Stempeucel® does not elicit systemic or localized toxic effect.
- It is non-tumorigenic and non-teratogenic in nature.