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- Title
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.
- Authors
Arici, Vittorio; Perotti, Cesare; Fabrizio, Calliada; Del Fante, Claudia; Ragni, Franco; Alessandrino, Francesco; Viarengo, Gianluca; Pagani, Michele; Moia, Alessia; Tinelli, Carmine; Bozzani, Antonio
- Abstract
<bold>Objectives: </bold>Demonstrate the safety and effectiveness of highly purified CD133+ autologous stem cells in critical limb ischemia (CLI).<bold>Design: </bold>Prospective single-center not randomized. Clinicaltrials.gov identifier: NCT01595776 METHODS: Eight 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.<bold>Results: </bold>No 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.<bold>Conclusions: </bold>Highly purified autologous CD133+ cells can stimulate neo-angiogenesis, as based on clinical and CEUS data.
- Subjects
ISCHEMIA treatment; PAIN management; STEM cell transplantation; AMPUTATION; ANTIGENS; AUTOGRAFTS; BONE marrow; CELL separation; CLINICAL trials; COMPARATIVE studies; EXTREMITIES (Anatomy); GRANULOCYTE-colony stimulating factor; FLOW cytometry; GLYCOPROTEINS; ISCHEMIA; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; PEPTIDES; RESEARCH; STEM cells; WOUND healing; EVALUATION research; TREATMENT effectiveness; PATHOLOGIC neovascularization
- Publication
Journal of Translational Medicine, 2015, Vol 13, p1
- ISSN
1479-5876
- Publication type
journal article
- DOI
10.1186/s12967-015-0697-4