NCT00765050

A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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)

Conditions

• Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF

Interventions

Type	Name	Description
BIOLOGICAL	CD133+ cells transplant	intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-10-02
• Last updated: 2014-04-07

Locations

5 sites across 1 country: Spain