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Autologous expanded mesenchymal stem cells (derived from lipoaspirate) is an investigational cell therapy developed by the Fundación para la Investigación Biomédica del Hospital Universitario La Paz in Spain. The active ingredient consists of the patient's own (autologous) mesenchymal stem cells harvested from adipose tissue obtained via lipoaspiration, which are then expanded ex vivo before administration. The therapy is delivered via intramuscular implantation into the affected limb and is intended to treat non-revascularizable critical limb ischemia (CLI), a severe manifestation of peripheral arterial disease where standard revascularization is not feasible. Its proposed mechanism of action involves the angiogenic, regenerative, and immunomodulatory properties of mesenchymal stem cells, which may promote new blood vessel formation and improve tissue perfusion. The drug was evaluated in a completed Phase IIa clinical trial in Spain assessing feasibility and safety, with follow-up at 6 and 12 months measuring limb salvage, quality of life, vascular imaging, tissue oxygenation (TcPO2), and ankle-brachial index (ABI).
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