ObjectivesDemonstrate the safety and effectiveness of highly purified CD133+ autologous stem cells in critical limb ischemia (CLI).DesignProspective single-center not randomized. Clinicaltrials.gov identifier: NCT01595776MethodsEight patients with a history of stable CLI were enrolled in a period of 2 years. After bone marrow stimulation and single leukapheresis collection, CD133+ immunomagnetic cell selection was performed. CD133+ cells in buffer phosphate suspension was administered intramuscularly. Muscular and arterial contrast enhanced ultra sound (CEUS), lesion evolution and pain management were assessed preoperatively and 3, 6 and 12 months after the implant.ResultsNo patient had early or late complications related to the procedure. Two patients (25 %) didn’t get any relief from the treatment and underwent major amputation. Six patients (75 %) had a complete healing of the wounds, rest pain cessation and walking recovery. An increase in CEUS values was shown in all eight patients at 6 months and in the six clinical healed patients at 12 months and had statistical relevance.ConclusionsHighly purified autologous CD133+ cells can stimulate neo-angiogenesis, as based on clinical and CEUS data.Electronic supplementary materialThe online version of this article (doi:10.1186/s12967-015-0697-4) contains supplementary material, which is available to authorized users.
The presence of aortic abdominal aneurysm is always to be considered in the evaluation of an elderly patient complaining lower back pain or lower limb neuropathy of recent onset, especially in the presence of a degenerative process of the spine.
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