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This investigational cell therapy consists of allogeneic mesenchymal stem cells derived from the Wharton's jelly of the umbilical cord (allo-WJ-MSCs). Developed by the Fundación Oftalmológica de Santander (FOSCAL) in Colombia, it is specifically designed for the treatment of chronic limb-threatening ischemia (CLTI) in diabetic patients. The therapy is administered as a single dose injected into the periadventitial layer of the arterial walls under eco-Doppler guidance. The mechanism of action involves the paracrine secretion of pro-angiogenic and immunomodulatory factors by the stem cells, which promotes neovascularization, reduces inflammation, and facilitates tissue repair in severely ischemic limbs. Clinical pilot data demonstrated significant efficacy in limb salvage compared to placebo in patients with advanced Rutherford classification stages.
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