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.
abstract: OBJECTIVE
  Demonstrate the safety and effectiveness of highly purified CD133+ autologous stem cells in critical limb ischemia (CLI).
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Highly purified autologous CD133+ cells can stimulate neo-angiogenesis, as based on clinical and CEUS data.
authors.affiliation: Vascular Surgery Unit, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Piazzale Golgi 19, 27100, Pavia, Italy. vittorio.arici@gmail.com.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Arici
authors.affiliation: Haemotransfusional Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. c.perotti@smatteo.pv.it.
authors.forename: Cesare
authors.initials: C
authors.lastname: Perotti
authors.affiliation: Radiology Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. f.calliada@smatteo.pv.it.
authors.forename: Calliada
authors.initials: C
authors.lastname: Fabrizio
authors.affiliation: Haemotransfusional Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. c.delfante@smatteo.pv.it.
authors.forename: Claudia
authors.initials: C
authors.lastname: Del Fante
authors.affiliation: Vascular Surgery Unit, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Piazzale Golgi 19, 27100, Pavia, Italy. f.ragni@smatteo.pv.it.
authors.forename: Franco
authors.initials: F
authors.lastname: Ragni
authors.affiliation: Radiology Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. pragia@hotmail.com.
authors.forename: Francesco
authors.initials: F
authors.lastname: Alessandrino
authors.affiliation: Haemotransfusional Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. lucaviare@gmail.com.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Viarengo
authors.affiliation: Anesthesiology and Intensive Care Unit 2, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. m.pagani@smatteo.pv.it.
authors.forename: Michele
authors.initials: M
authors.lastname: Pagani
authors.affiliation: Vascular Surgery Unit, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Piazzale Golgi 19, 27100, Pavia, Italy. alessia.moia83@gmail.com.
authors.forename: Alessia
authors.initials: A
authors.lastname: Moia
authors.affiliation: Statistics and Epidemiology Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. c.tinelli@smatteo.pv.it.
authors.forename: Carmine
authors.initials: C
authors.lastname: Tinelli
authors.affiliation: Vascular Surgery Unit, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Piazzale Golgi 19, 27100, Pavia, Italy. a.bozzani@smatteo.pv.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: Bozzani
mesh_terms: D000071916:AC133 Antigen; D000328:Adult; D000671:Amputation, Surgical; D015703:Antigens, CD / Q000378:metabolism*; D001853:Bone Marrow / Q000473:pathology; D005121:Extremities / Q000473:pathology*; D005260:Female; D005434:Flow Cytometry; D006023:Glycoproteins / Q000378:metabolism*; D016179:Granulocyte Colony-Stimulating Factor / Q000378:metabolism; D006801:Humans; D018189:Immunomagnetic Separation; D007511:Ischemia / Q000000981:diagnostic imaging* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009389:Neovascularization, Pathologic; D059408:Pain Management; D010455:Peptides / Q000378:metabolism*; D011446:Prospective Studies; D033581:Stem Cell Transplantation; D013234:Stem Cells / Q000166:cytology*; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014463:Ultrasonography; D014945:Wound Healing
chemical_list: D000071916:AC133 Antigen; D015703:Antigens, CD; D006023:Glycoproteins; C000606023:PROM1 protein, human; D010455:Peptides; D016179:Granulocyte Colony-Stimulating Factor