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The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs. The secondary objectives are: * To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood. * To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs. * To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients
A total of up to 20 diabetic patients with critic ischemia of lower limbs will be included in the study. Patients will be administered with CD133+ cells, that previously have been obtained of their peripheral blood after mobilization with G-CSF The study is divided in three phases: Pre-treatment (previous 4 weeks of CD133+ cells mobilization). Treatment (cells mobilization, CD133+ transplant, 24 hours after infusion visit, 4, 12 and 24 weeks after transplant visits) Follow-up (9 and 12 months after transplant visits)
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Hospital Virgen de la Arrixaca
Murcia, Spain
Clínica Universitaria de Navarra
Pamplona, Spain
Hospital Clínico Universitario
Salamanca, Spain
Hospital Joan XIII de
Tarragona, Spain
Hospital Clínico Universitario
Valladolid, Spain
Start Date
January 1, 2009
Primary Completion Date
October 1, 2012
Completion Date
October 1, 2012
Last Updated
April 7, 2014
13
ACTUAL participants
CD133+ cells transplant
BIOLOGICAL
Lead Sponsor
PETHEMA Foundation
Data Source & Attribution
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