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临床试验/NCT00753025
NCT00753025已完成2 期

Randomized Double Blind Placebo-Controlled Research Of Treatment Efficiency For Patients With Lower Extremity Arteriosclerosis Obliterans By Autologous Transplantation Of Bone Marrow Progenitor Cells

Clinical Center of Cellular Technologies, Russia0 个研究点目标入组 42 人开始时间: 2006年10月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
42
主要终点
Increasing of painless walking distance

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
39 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Increasing of painless walking distance

时间窗: Within the first 30 days, 6 months and 12 months after injection

次要结局

未报告次要终点

研究者

发起方
Clinical Center of Cellular Technologies, Russia
申办方类型
Other Gov

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