Autologous Bone Marrow For Lower Extremity Ischemia Treating
Randomized Double Blind Placebo-Controlled Research Of Treatment Efficiency For Patients With Lower Extremity Arteriosclerosis Obliterans By Autologous Transplantation Of Bone Marrow Progenitor Cells
1 other identifier
interventional
42
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2006
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 9, 2008
CompletedFirst Posted
Study publicly available on registry
September 16, 2008
CompletedSeptember 16, 2008
September 1, 2008
8 months
September 9, 2008
September 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increasing of painless walking distance
Within the first 30 days, 6 months and 12 months after injection
Study Arms (3)
CD133
EXPERIMENTALTNC
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Bone marrow is aspirated at patients in all arms. Arm "TNC" receives injection of total nucleated cells into ischemic muscle
arm "CD133" receives injection of isolated CD 133+ cells
arm "placebo" receives injection of saline
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clinical Center of Cellular Technologies, Russialead
- Samara State Medical Universitycollaborator
- Regional hospital of Samaracollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Olga Tyumina, PhD
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 9, 2008
First Posted
September 16, 2008
Study Start
October 1, 2006
Primary Completion
June 1, 2007
Study Completion
February 1, 2008
Last Updated
September 16, 2008
Record last verified: 2008-09