Autologous immuno magnetically selected CD133+ stem cells in the treatment of no-option critical limb ischemia: clinical and contrast enhanced ultrasound assessed results in eight patients

Abstract

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 Circulating Biomarkers Concentration and Endoleak Monitoring After Stentgraft of Abdominal Aorta

“…A meta-analysis showed an accumulated specificity of 98%, respectively a sensitivity of 88 %, for the finding of an endoleak. The accuracy of CEUS in the recognition and classification of endoleaks after EVAR seems to be high, as recently demonstrated prospectively with a sensitivity of 97%, a specificity of 100% and an accuracy of 99% [4][5][6].…”

“…A meta-analysis showed an accumulated specificity of 98%, respectively a sensitivity of 88 %, for the finding of an endoleak. The accuracy of CEUS in the recognition and classification of endoleaks after EVAR seems to be high, as recently demonstrated prospectively with a sensitivity of 97%, a specificity of 100% and an accuracy of 99% [4][5][6].Furthermore, it is postulated that the continued perfusion of the aneurysmal sac in patient with endoleak perpetuates the aortic wall remodelling resulting in circulating biomarkers release. Matrix metalloproteinases (MMPs) play a pivotal role in the integrity and composition of the extracellular matrix, whose major components are collagen and elastin.…”

Recent Advances in Endothelial Progenitor Cells Toward Their Use in Clinical Translation

“…While some of the clinical data from Table 1 was published, several of these papers were not included in this section for overall analysis for the following reasons: one paper did not use the term EPC but instead used the term “angiogenic precursor cells” (19), five papers included cells identified only using a single cell surface marker [e.g., CD133 + (17, 18, 20) or CD34 + (21, 29)], and one did not specifically define the cell type (24). It was concluded that these papers could not be classified according to our search criteria as being interventional EPC studies, and thus excluded.…”

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia ― The SCELTA Trial ―

“…There was a gradual, significant increase in muscle perfusion at both the upper calf and forefoot seen in all follow-up examinations in both groups (Figure 4). Since we believe muscle represents the most direct functional test to define recovery of limb vascularization, 29 we chose this parameter as a primary endpoint in the present study. As expected, there was a significant correlation between muscle perfusion and other vascular parameters, particularly TC PO2 (Figure S2).…”