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Clinical Trials/NCT00442143
NCT00442143
Unknown
Phase 1

Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells

Odense University Hospital1 site in 1 country10 target enrollmentJanuary 2007
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ConditionsIschemia

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Ischemia
Sponsor
Odense University Hospital
Enrollment
10
Locations
1
Primary Endpoint
Transcutaneous oxygen pressure
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization

Detailed Description

10 patients with severe lower limb ischemia will be included in this pilote trial. Bonemarrow aspiration will be performed and and the monocuclear cells isolated an injected into the gastrocnemius. The patiens are followed for 4 months. Were trancutaneous oxygenpressure, ankel and toe blood pressure is measured.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
December 2007
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Ankle blood pressure \< 70 mmgHG
  • •Either pain at rest and/or ischemic wound
  • •No possible surgical treatment

Exclusion Criteria

  • •Infection
  • •Malignant disease

Outcomes

Primary Outcomes

Transcutaneous oxygen pressure

1st toe blood pressure (strain gauge)

Ankle blood pressure

Wound healing

Pain

Secondary Outcomes

  • amputation
  • Infection

Study Sites (1)

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