Limb ischemia, stem cells, bone marrow cells, vasculogenesis, arteriogenesis. (NLD: Perifeer vaatlijden, stamcellen, beenmerg, arteriogenese).
Conditions
Interventions
Hospital admittance was planned in a short-stay setting (24-48 hrs). The harvest procedure was performed according to standard protocols for bone marrow donation for allogenic transplantation. 750 mil
Sponsors
Leiden University Medical Center.
Eligibility
Inclusion criteria
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; 3. Male of female, >18 years old; 4. Life expectancy > 1 year; 5. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Candidates for angioplasty or bypass procedures; 2. Inability to undergo bone marrow harvesting; 3. Life threatening co-morbidity; 4. INR >2; 5. History of malignant disease in 5 years prior to treatment; 6. Inability to undergo arterial catheterization; 7. Inability to follow the protocol and to comply with the follow up requirements; 8. Any other conditions that, in the opinion of the investigators, could interfere with the therapy or could pose a significant threat to the subject if the investigational therapy was to be initiated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Wound healing / limb salvage (Fontaine 3/4); 2. Painfree walking distance (Fontaine 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ankle/brachial index; 2. Brief Pain Inventory. | — |
Contacts
Public ContactJan H. Lindeman
Leiden University Medical Center Dpt. of Vascular Surgery. PO-box 9600
Outcome results
None listed