Intramuscular or combined intramuscular/intra-arterial administration of bone marrow mononuclear cells in patients with advanced limb ischemia.
Completed
- Conditions
- imb ischemia, stem cells, bone marrow cells, vasculogenesis, arteriogenesis. <br />(NLD: Perifeer vaatlijden, stamcellen, beenmerg, arteriogenese).
- Registration Number
- NL-OMON22349
- Lead Sponsor
- eiden University Medical Center.
- Brief Summary
J Cardiovasc Surg (Torino). 2008 Feb;49(1):51-8.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
1. Disabling claudication (Fontaine’s stages IIb/III or Rutherford’s categories 3/4) or critical limb ischemia (Fontaine’s stages IV or Rutherford’s categories 5/6) despite > 6 months optimal medical therapy;
2. Ineligibility for angioplasty or bypass procedures;
Exclusion Criteria
1. Candidates for angioplasty or bypass procedures;
2. Inability to undergo bone marrow harvesting;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Wound healing / limb salvage (Fontaine 3/4);<br /><br>2. Painfree walking distance (Fontaine 2).
- Secondary Outcome Measures
Name Time Method 1. Ankle/brachial index;<br /><br>2. Brief Pain Inventory.