Autologous Bone Marrow For Lower Extremity Ischemia Treating
NCT00753025 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2008-09-16
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
Conditions
- Lower Extremity Ischemia
Interventions
- PROCEDURE
-
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
- PROCEDURE
-
Bone marrow aspiration , injection of isolated CD 133+ cells
arm "CD133" receives injection of isolated CD 133+ cells
- PROCEDURE
-
Bone marrow aspiration, injection of saline
arm "placebo" receives injection of saline
Sponsors & Collaborators
-
Samara State Medical University
collaborator OTHER -
Regional hospital of Samara
collaborator UNKNOWN -
Clinical Center of Cellular Technologies, Russia
lead OTHER_GOV
Principal Investigators
-
Olga Tyumina, PhD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 39 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-10-31
- Primary Completion
- 2007-06-30
- Completion
- 2008-02-29
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