Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF Clinical Trial
Official title:
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
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)
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment