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

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Abstract

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.

Original languageEnglish
JournalJournal of Translational Medicine
DOIs
Publication statusAccepted/In press - Nov 3 2015

Keywords

  • Contrast enhanced ultrasound
  • Critical limb ischemia
  • Peripheral arterial disease
  • Stem cell therapy

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

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