Status:
COMPLETED
Autologous Bone Marrow For Lower Extremity Ischemia Treating
Lead Sponsor:
Clinical Center of Cellular Technologies, Russia
Collaborating Sponsors:
Samara State Medical University
Regional hospital of Samara
Conditions:
Lower Extremity Ischemia
Eligibility:
MALE
39-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether autologous bone marrow derived cells and isolated CD133+ fraction are effective in the treatment limb ischemia
Detailed Description
The number of patients with low limb obliterating atherosclerosis steadily grows and compounds more than 20-25 % from all kinds of a cardiovascular pathology. At conservation of this tendency to 2020 ...
Eligibility Criteria
Inclusion
- an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification)
- a painless walking distance of 10-50 m
- pulse absence on аа. dorsalis pedis, tibialis posterior, poplitea
- absence of a ischemia in a rest and necrotic changes
- mainly distal form of disease (a lesion of a superficial femoral artery, a popliteal artery, anticnemion arteries) according to an angiography that testifies to impossibility of reconstructive operation performance
- patients after a lumbar sympathectomy and a tibial bone osteoperforations executed previously
- heavy smokers
Exclusion
- insulin depended diabetes
- myocardial infarction or a stroke within last year
- an idiopathic hypertensia III stage
- anaemia and other diseases of blood
- decompensation of the chronic diseases which are contraindications to any surgical operation
- HIV infection
- a virus hepatitis
- oncologic diseases
- chemotherapy in the anamnesis
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00753025
Start Date
October 1 2006
End Date
February 1 2008
Last Update
September 16 2008
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