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ICS-001 + autologous peripheral blood mononuclear cells (PBMNCs) is an investigational cell-based biologic therapy designed for the treatment of chronic limb-threatening ischemia (CLTI). The therapy consists of a biodegradable scaffold, ICS-001—an L-lactic acid/ε-caprolactone copolymer particle whose surface is coated with hydroxyapatite (HAp)—combined with autologous PBMNCs mobilized using G-CSF and Plerixafor. These cells, which include monocytes, lymphocytes, and CD34+ hematopoietic stem cells, are harvested from the patient's own peripheral blood, mixed with the scaffold, and injected into the ischemic treatment site. The scaffold provides a three-dimensional matrix that supports cell adhesion and survival, facilitating the localized and sustained release of pro-angiogenic cytokines and growth factors to promote neovascularization in patients with arteriosclerosis obliterans or Buerger's disease who are not candidates for standard revascularization.
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