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

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)

Inclusion Criteria:

• According to the investigator opinion, patient is able to carry out with all the clinical trial requirements
• Patient must volunteer sign the inform consent before any study specific test, that is not part of the common patient attention, is performed. Patient must know that he/she can abandon the study at any time with no damage to his/her posterior attention
• Age 18 to 75
• A diagnosis of chronic critic ischemia of the lower limbs
• Diabetes Mellitus active
• III or IV stages (Fontaine classification): resting pain, ulcer or minor gangrene with no major amputation
• General contraindication or local inoperability or refractory/progression after previous surgical treatment, according to the investigator criteria
• If female reproductive potential, negative pregnancy test

Exclusion Criteria:

• Pregnant or currently breast feeding women
• Acute myocardial infarction within the last 3 years
• Non re-vascular unstable angina pectoris
• History of ischemia stroke within the last 3 years
• Neoplasia at the time of inclusion or Chemotherapy or Radiotherapy treatment in the last 5 years
• Chronic renal insufficiency
• G-CSF contraindication
• A non well controlled serious concomitant disease
• History of serious thrombotic episodes within the past 3 years
• Patients who have received other investigational therapy within 30 days previous to the study inclusion
• Patients currently in other clinical trial or receiving any other investigational agent