Arteritis, Peripheral Arterial Disease, Thromboangiitis Obliterans
Conditions
Brief summary
To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral blood mononuclear cells in treatment of critical limb ischemia
Interventions
OTHERautologous purified CD34+ cells
OTHERautologous peripheral blood mononuclear cells
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Rutherford scale of 4-5 * thromboangiitis obliterans, peripheral arterial disease, or arteritis caused by other etiologies, such as collagen diseases * surgical or endovascular procedures are considered unlikely to have successful long-term revascularization, or have failed * more than 4 weeks of critical limb ischemia * if present, a non-healing ulcer after more than 4 weeks of optimal care by a wound care physician and a nurse
Exclusion criteria
* within 3 months of an acute myocardial infarction * any contraindication for the administration of granulocyte colony stimulating factor (G-CSF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major-amputation-free survival rate | at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| improvement on transcutaneous partial oxygen pressure | at 3 months |
Other
| Measure | Time frame |
|---|---|
| improvement on peak pain-free walking time | at 3 months |
Countries
China
Contacts
Primary ContactZhihui Dong, M.D.
Outcome results
None listed