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Autologous Bone Marrow For Lower Extremity Ischemia Treating

This study has been completed.
Sponsor:
Collaborators:
State medical University of Samara
Regional hospital of Samara
Information provided by:
Clinical Center of Cellular Technologies, Russia
ClinicalTrials.gov Identifier:
NCT00753025
First received: September 9, 2008
Last updated: September 15, 2008
Last verified: September 2008
History of Changes

September 9, 2008
September 15, 2008
October 2006
June 2007   (final data collection date for primary outcome measure)
Increasing of painless walking distance [ Time Frame: Within the first 30 days, 6 months and 12 months after injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00753025 on ClinicalTrials.gov Archive Site
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Autologous Bone Marrow For Lower Extremity Ischemia Treating
Randomized Double Blind Placebo-Controlled Research Of Treatment Efficiency For Patients With Lower Extremity Arteriosclerosis Obliterans By Autologous Transplantation Of Bone Marrow Progenitor Cells

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

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 the amputation percentage executed due to vessel diseases, can reach 45 %. Hemodynamics improvement in an extremity by surgery is possible at 40 - 70 % of patients even with the widespread and plural lesion of arteries, but results are not always satisfactory. The most actual is the problem of angiosurgical help to patients with distal forms of arterial occlusions, due to the difficulty or impossibility performing reconstructive interventions. In these cases the operations of an indirect revascularization referred on stimulation of a collateral blood flow are carried out. However, despite the reached successes, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. To date the most perspective methods of neoangiogenesis stimulation are a cellular therapy and gene-engineering technologies. Experimental researches on a model of local limb ischemia showed possibility of use of various cells for neoangiogenesis stimulation. A number of clinical researches at patients with obliterating limb diseases has shown efficacy of cellular therapy even at a critical ischemia. However randomized, the placebo-controlled researches based on principles of evidence based medicine while it is not enough for the convincing conclusions.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lower Extremity Ischemia
  • Procedure: Bone marrow aspiration, injection of cells

    Bone marrow is aspirated at patients in all arms.

    Arm "TNC" receives injection of total nucleated cells into ischemic muscle

  • Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells
    arm "CD133" receives injection of isolated CD 133+ cells
  • Procedure: Bone marrow aspiration, injection of saline
    arm "placebo" receives injection of saline
  • Experimental: CD133
    Intervention: Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells
  • Experimental: TNC
    Intervention: Procedure: Bone marrow aspiration, injection of cells
  • Placebo Comparator: Placebo
    Intervention: Procedure: Bone marrow aspiration, injection of saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2008
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Male
39 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00753025
CCCT001
Yes
Andrey Toropovskiy, Clinical Center of Cellular Technologies, Russia
Clinical Center of Cellular Technologies, Russia
  • State medical University of Samara
  • Regional hospital of Samara
Study Director: Olga Tyumina, PhD
Clinical Center of Cellular Technologies, Russia
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP