Autologous Bone Marrow For Lower Extremity Ischemia Treating

NCT00753025 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2008-09-16

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00753025 on ClinicalTrials.gov