Autologous Bone Marrow For Lower Extremity Ischemia Treating
September 15, 2008 updated by: Clinical Center of Cellular Technologies, Russia
Randomized Double Blind Placebo-Controlled Research Of Treatment Efficiency For Patients With Lower Extremity Arteriosclerosis Obliterans By Autologous Transplantation Of Bone Marrow Progenitor Cells
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
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
39 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: Placebo
|
arm "placebo" receives injection of saline
|
|
EXPERIMENTAL: CD133
|
arm "CD133" receives injection of isolated CD 133+ cells
|
|
EXPERIMENTAL: TNC
|
Bone marrow is aspirated at patients in all arms. Arm "TNC" receives injection of total nucleated cells into ischemic muscle |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Increasing of painless walking distance
Time Frame: Within the first 30 days, 6 months and 12 months after injection
|
Within the first 30 days, 6 months and 12 months after injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Olga Tyumina, PhD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (ACTUAL)
June 1, 2007
Study Completion (ACTUAL)
February 1, 2008
Study Registration Dates
First Submitted
September 9, 2008
First Submitted That Met QC Criteria
September 15, 2008
First Posted (ESTIMATE)
September 16, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
September 16, 2008
Last Update Submitted That Met QC Criteria
September 15, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCCT001
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