Status:
TERMINATED
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
Lead Sponsor:
PETHEMA Foundation
Conditions:
Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 ob...
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 pe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00765050
Start Date
January 1 2009
End Date
October 1 2012
Last Update
April 7 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Virgen de la Arrixaca
Murcia, Spain
2
Clínica Universitaria de Navarra
Pamplona, Spain
3
Hospital Clínico Universitario
Salamanca, Spain
4
Hospital Joan XIII de
Tarragona, Spain