Back to resultsTreatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells (DANCELL-CLI)
Primary Purpose
Ischemia
Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Stem cell implantation
Sponsored by
About this trial
This is an interventional treatment trial for Ischemia focused on measuring CLI, PAOD, Severe lower limb ischemia
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
Sites / Locations
- Department of endocrinology M, Odense University HospitalRecruiting
Outcomes
Primary Outcome Measures
Transcutaneous oxygen pressure
1st toe blood pressure (strain gauge)
Ankle blood pressure
Wound healing
Pain
Secondary Outcome Measures
amputation
Infection
Full Information
NCT ID
NCT00442143
First Posted
February 28, 2007
Last Updated
July 22, 2010
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00442143
Brief Title
Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
Acronym
DANCELL-CLI
Official Title
Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
Keywords
CLI, PAOD, Severe lower limb ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Stem cell implantation
Primary Outcome Measure Information:
Title
Transcutaneous oxygen pressure
Title
1st toe blood pressure (strain gauge)
Title
Ankle blood pressure
Title
Wound healing
Title
Pain
Secondary Outcome Measure Information:
Title
amputation
Title
Infection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Malthe AM Kristiansen, MD
Phone
+4565504081
Email
mkristiansen@health.sdu.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustapha Kassem, MD
Organizational Affiliation
Department of endocrinology M, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of endocrinology M, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
We'll reach out to this number within 24 hrs