Critical limb ischemia (CLI) is estimated to develop in 500 - 1000 individuals per million per year and has a major impact on quality of life. Despite recent advances in surgical and radiological vascular procedures, a larger number of patients (~40%) is not eligible for these revascularisation procedures and new strategies for revascularisation need to be explored. Recent evidence indicated that bone marrow derived (BM) mononuclear cells (MNC) are a potential new therapeutic agent, and several clinical studies have already been conducted, all reporting very promising results for progenitor cell-based therapies in CLI patients. However, no definite proof is available, as the clinical studies thus far have been small and lacked double-blind controls.

JUVENTAS is a randomised, double-blind, placebo-controlled trial in 110 - 160 patients with CLI to investigate the clinical effects of repeated intra-arterial infusion of BM-MNC in these patients.