Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells - Full Text View

Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells (DANCELL-CLI)

This study is currently recruiting participants.

Verified by Odense University Hospital, March 2007

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00442143

Purpose

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

Condition	Intervention	Phase
Ischemia	Procedure: Stem cell implantation	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

Transcutaneous oxygen pressure
1st toe blood pressure (strain gauge)
Ankle blood pressure
Wound healing
Pain

Secondary Outcome Measures:

amputation
Infection

Estimated Enrollment:	10
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2007

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.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442143

Contacts

Contact: Malthe AM Kristiansen, MD

+4565504081

mkristiansen@health.sdu.dk

Locations

Denmark
Department of endocrinology M, Odense University Hospital	Recruiting
Odense, Denmark, 5000

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator:

Moustapha Kassem, MD

Department of endocrinology M, Odense University Hospital

More Information

Study ID Numbers:	024
Study First Received:	February 28, 2007
Last Updated:	March 21, 2007
ClinicalTrials.gov Identifier:	NCT00442143
Health Authority:	Denmark: National Board of Health

Keywords provided by Odense University Hospital:

CLI
PAOD
Severe lower limb ischemia

Study placed in the following topic categories:

Ischemia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009