Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells

Ischemia Clinical Trial

— DANCELL-CLI  

Official title:

Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00442143
• Other study ID #: 024
• Status: Recruiting
• Phase: Phase 1
• First received: February 28, 2007
• Last updated: July 22, 2010
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2007
• Source: Odense University Hospital
• Contact: Malthe AM Kristiansen, MD
• Phone: +4565504081
• Email: mkristiansen[@]health.sdu.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Ankle blood pressure < 70 mmgHG

• Either pain at rest and/or ischemic wound

• No possible surgical treatment

Exclusion Criteria:

• Infection

• Malignant disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia

Intervention

Procedure:
• Stem cell implantation

Locations

Country	Name	City	State
Denmark	Department of endocrinology M, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcutaneous oxygen pressure
Primary	1st toe blood pressure (strain gauge)
Primary	Ankle blood pressure
Primary	Wound healing
Primary	Pain
Secondary	amputation
Secondary	Infection