TY - JOUR
T1 - Autologous immuno magnetically selected CD133+ stem cells in the treatment of no-option critical limb ischemia
T2 - Clinical and contrast enhanced ultrasound assessed results in eight patients
AU - Arici, Vittorio
AU - Perotti, Cesare
AU - Fabrizio, Calliada
AU - Fante, Claudia
AU - Ragni, Franco
AU - Alessandrino, Francesco
AU - Viarengo, Gianluca
AU - Pagani, Michele
AU - Moia, Alessia
AU - Tinelli, Carmine
AU - Bozzani, Antonio
PY - 2015/11/3
Y1 - 2015/11/3
N2 - Objectives: Demonstrate the safety and effectiveness of highly purified CD133+ autologous stem cells in critical limb ischemia (CLI). Design: 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.
AB - Objectives: Demonstrate the safety and effectiveness of highly purified CD133+ autologous stem cells in critical limb ischemia (CLI). Design: 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.
KW - Contrast enhanced ultrasound
KW - Critical limb ischemia
KW - Peripheral arterial disease
KW - Stem cell therapy
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U2 - 10.1186/s12967-015-0697-4
DO - 10.1186/s12967-015-0697-4
M3 - Article
AN - SCOPUS:84960411828
JO - Journal of Translational Medicine
JF - Journal of Translational Medicine
SN - 1479-5876
ER -