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Completed

NCT Number: NCT00753025

Autologous Bone Marrow For Lower Extremity Ischemia Treating

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

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Key information

Age range

39 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone marrow aspiration, injection of cells

Procedure

Bone marrow is aspirated at patients in all arms.

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

Bone marrow aspiration , injection of isolated CD 133+ cells

Procedure

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

Bone marrow aspiration, injection of saline

Procedure

arm "placebo" receives injection of saline

Primary outcomes

  1. Increasing of painless walking distance

    Time frame: Within the first 30 days, 6 months and 12 months after injection

Sponsors and collaborators

Lead sponsor

Clinical Center of Cellular Technologies, Russia

Other Gov

Collaborators

  • Regional hospital of Samara
  • Samara State Medical University

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Sep 16, 2008
Registry last updated
Sep 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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