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

Study Overview
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Brief Summary
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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

Detailed Description
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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)

Official Title
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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

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

Intervention / Treatment
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* Biological: CD133+ cells transplant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD133+ cells<br>CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs. | Biological: CD133+ cells transplant<br>* intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood |  | 2 months | 
| To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs |  | 12 months | 
| To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cellular therapy, CD133+