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Autologous Bone Marrow For Lower Extremity Ischemia Treating
This study has been completed.
First Received: September 9, 2008   Last Updated: September 15, 2008   History of Changes
Sponsors and Collaborators: Clinical Center of Cellular Technologies, Russia
State medical University of Samara
Regional hospital of Samara
Information provided by: Clinical Center of Cellular Technologies, Russia
ClinicalTrials.gov Identifier: NCT00753025
  Purpose

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


Condition Intervention Phase
Lower Extremity Ischemia
Procedure: Bone marrow aspiration, injection of cells
Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells
Procedure: Bone marrow aspiration, injection of saline
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Double Blind Placebo-Controlled Research Of Treatment Efficiency For Patients With Lower Extremity Arteriosclerosis Obliterans By Autologous Transplantation Of Bone Marrow Progenitor Cells

Further study details as provided by Clinical Center of Cellular Technologies, Russia:

Primary Outcome Measures:
  • Increasing of painless walking distance [ Time Frame: Within the first 30 days, 6 months and 12 months after injection ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: October 2006
Study Completion Date: February 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CD133: Experimental Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells
arm "CD133" receives injection of isolated CD 133+ cells
TNC: Experimental 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

Placebo: Placebo Comparator Procedure: Bone marrow aspiration, injection of saline
arm "placebo" receives injection of saline

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 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.

  Eligibility

Ages Eligible for Study:   39 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753025

Sponsors and Collaborators
Clinical Center of Cellular Technologies, Russia
State medical University of Samara
Regional hospital of Samara
Investigators
Study Director: Olga Tyumina, PhD Unaffiliated
  More Information

No publications provided

Responsible Party: Clinical Center of Cellular Technologies, Russia ( Andrey Toropovskiy )
Study ID Numbers: CCCT001
Study First Received: September 9, 2008
Last Updated: September 15, 2008
ClinicalTrials.gov Identifier: NCT00753025     History of Changes
Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Clinical Center of Cellular Technologies, Russia:
lower extremity ischemia
Bone marrow
Progenitor cells
Neoangiogenesis

Study placed in the following topic categories:
Arterial Occlusive Diseases
Arteriosclerosis Obliterans
Vascular Diseases
Neovascularization, Pathologic
Ischemia
Arteriosclerosis

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Pathologic Processes
Arteriosclerosis Obliterans
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Ischemia

ClinicalTrials.gov processed this record on May 07, 2009