Autologous Endothelial Progenitor Cells (EPCs) From Peripheral Blood in the Treatment of Critical Limb Ischemia
Aim: to value the safety and efficacy of local intramuscular administration of immunoselected autologous endothelial progenitor cells in the treatment of critical limb ischemia in patients without revascularization options.
Primary goal: to value the feasibility of mobilization, harvesting, immunoselection and auto transplantation of endothelial progenitor cells.
Secondary goal: to value the efficacy of local administration of autologous endothelial progenitor cells in the treatment of critical limb ischemia
|Critical Limb Ischemia||Other: Endothelial progenitor cells intramuscular implant||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Autologous Immunomagnetic Selected cd133+ Cells in the Treatment of No-option Critical Limb Ischemia: Clinical and Ceus Assessed Results.|
- Contrast enhanced ultrasound (CEUS) [ Time Frame: 3-6-12 months ]Muscular and arterial ultrasound before and after endovenous injection of contrast medium (SonoVue BR1; Bracco, Milan, Italy)
- Pain relief [ Time Frame: 3-6-12 months ]Monitoring the use of pain killing drugs
- ulcer healing [ Time Frame: 3-6-12 months ]monitoring the healing of trophic lesions
|Study Start Date:||January 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: single arm: autologous EPCs||
Other: Endothelial progenitor cells intramuscular implant
After marrow stimulation the CD133+ cell count was monitored daily. Each leukapheresis collection was diluted with 10% acide citrate dextrose (ACD-A)CD133 immunomagnetic cell selections were performed . After loco-regional anesthesia and below the knee cutaneous disinfection, 45-48 ml of autologous CD133+ saline solution suspension is administered intramuscularly with 1 ml deep injection through 18G needle. The injections were so allocated: 10 ml in the anterior compartment of leg, 10 ml in the superficial posterior compartment, 10 ml in the deep posterior compartment, 10 ml in the lateral compartment and the remaining part in the foot.
Other Name: Cell therapy in critical limb ischemia.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01595776
|Fondazione IRCCS Policlinico San Matteo|
|Pavia, Italy, 27100|
|Study Director:||Attilio Odero, Professor||Department of Vascular Surgery - Fondazione IRCCS Policlinico S. Matteo, Pavia - Italy|