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Autologous Bone Marrow For Lower Extremity Ischemia Treating

NCT ID: NCT00753025

Last Updated: 2008-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Lower Extremity Ischemia

Keywords

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lower extremity ischemia Bone marrow Progenitor cells Neoangiogenesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CD133

Group Type EXPERIMENTAL

Bone marrow aspiration , injection of isolated CD 133+ cells

Intervention Type PROCEDURE

arm "CD133" receives injection of isolated CD 133+ cells

TNC

Group Type EXPERIMENTAL

Bone marrow aspiration, injection of cells

Intervention Type PROCEDURE

Bone marrow is aspirated at patients in all arms.

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

Placebo

Group Type PLACEBO_COMPARATOR

Bone marrow aspiration, injection of saline

Intervention Type PROCEDURE

arm "placebo" receives injection of saline

Interventions

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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

Intervention Type PROCEDURE

Bone marrow aspiration , injection of isolated CD 133+ cells

arm "CD133" receives injection of isolated CD 133+ cells

Intervention Type PROCEDURE

Bone marrow aspiration, injection of saline

arm "placebo" receives injection of saline

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

39 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Samara State Medical University

OTHER

Sponsor Role collaborator

Regional hospital of Samara

UNKNOWN

Sponsor Role collaborator

Clinical Center of Cellular Technologies, Russia

OTHER_GOV

Sponsor Role lead

Responsible Party

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Clinical Center of Cellular Technologies, Russia

Principal Investigators

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Olga Tyumina, PhD

Role: STUDY_DIRECTOR

Other Identifiers

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CCCT001

Identifier Type: -

Identifier Source: org_study_id