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

• Sponsor: Odense University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00442143
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 0.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ischemia	Procedure: Stem cell implantation	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
• Study Start Date: Jan 1, 2007
• Anticipated Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. Transcutaneous oxygen pressure []

2. 1st toe blood pressure (strain gauge) []

3. Ankle blood pressure []

4. Wound healing []

5. Pain []

Secondary Outcome Measures

1. amputation []

2. Infection []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of endocrinology M, Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• Odense University Hospital

Investigators

• Principal Investigator: Moustapha Kassem, MD, Department of endocrinology M, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00442143
• Other Study ID Numbers: 024
• First Posted: Mar 1, 2007
• Last Update Posted: Jul 23, 2010
• Last Verified: Mar 1, 2007

• Keywords provided by , ,: CLI; PAOD; Severe lower limb ischemia
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Jul 23, 2010