Ischemia
Conditions
Keywords
CLI, PAOD, Severe lower limb ischemia
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.
Interventions
PROCEDUREStem cell implantation
Sponsors
Odense University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1st toe blood pressure (strain gauge) | — |
| Wound healing | — |
| Pain | — |
| Transcutaneous oxygen pressure | — |
| Ankle blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Infection | — |
| amputation | — |
Countries
Denmark
Contacts
Primary ContactMalthe AM Kristiansen, MD
Outcome results
None listed