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Autologous Bone Marrow For Lower Extremity Ischemia Treating

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ClinicalTrials.gov Identifier: NCT00753025
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : September 16, 2008
Sponsor:
Collaborators:
Samara State Medical University
Regional hospital of Samara
Information provided by:
Clinical Center of Cellular Technologies, Russia

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

Condition or disease Intervention/treatment 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 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: CD133 Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells
arm "CD133" receives injection of isolated CD 133+ cells

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




Primary Outcome Measures :
  1. Increasing of painless walking distance [ Time Frame: Within the first 30 days, 6 months and 12 months after injection ]


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Ages Eligible for Study:   39 Years to 70 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753025


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

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Responsible Party: Andrey Toropovskiy, Clinical Center of Cellular Technologies, Russia
ClinicalTrials.gov Identifier: NCT00753025     History of Changes
Other Study ID Numbers: CCCT001
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: September 16, 2008
Last Verified: September 2008

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

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