Abstract
Cell therapy using mesenchymal stromal cells (MSCs) is a promising new avenue of treatment for critical limb ischemia (CLI). Preclinical studies have suggested that MSCs enhance neovascularization in ischemic limbs. In this commentary, we discuss a recent study by Gupta and colleagues, one of the first human trials using allogeneic MSCs for CLI, in relation to the current state of knowledge regarding cell therapy for CLI.
Highlights
Gupta and colleagues [1] reported the results of a randomized double-blind placebo-controlled phase I/II study on the efficacy and safety of allogeneic mesenchymal stromal cells (MSCs), administered by intramuscular injection in patients with critical limb ischemia (CLI)
The cell therapy product under investigation consisted of autologous bone marrow mononuclear cells (BMCs), which is a heterogeneous mixture of cells obtained by density gradient centrifugation of bone marrow aspirate
Infusion of BMCs has been reported to lead to improvements in ankle-brachial index (ABI) and pain-free walking distance
Summary
Gupta and colleagues [1] reported the results of a randomized double-blind placebo-controlled phase I/II study on the efficacy and safety of allogeneic mesenchymal stromal cells (MSCs), administered by intramuscular injection in patients with critical limb ischemia (CLI). A dozen clinical trials investigating stem or progenitor cell therapy in patients with CLI have been reported, but many were of limited size and not placebocontrolled [2]. The cell therapy product under investigation consisted of autologous bone marrow mononuclear cells (BMCs), which is a heterogeneous mixture of cells obtained by density gradient centrifugation of bone marrow aspirate.
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