Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells

NCT ID: NCT00442143

Last Updated: 2010-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Ischemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Stem cell implantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Infection
* Malignant disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Moustapha Kassem, MD

Role: PRINCIPAL_INVESTIGATOR

Department of endocrinology M, Odense University Hospital

Locations

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Department of endocrinology M, Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Malthe AM Kristiansen, MD

Role: CONTACT

+4565504081

Other Identifiers

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024

Identifier Type: -

Identifier Source: org_study_id

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