Peripheral artery disease/critical limb ischemia
Conditions
Interventions
Group 1:Intramuscular transplantation of purified CD34+ cells
Group 2:Intramuscular transplantation of peripheral blood mononuclear cell
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) male or female aged between 18 and 80 years; 2) diagnosis of limb ischemia due to vascular stenosis or vascular occlusion; 3) rest pain or tissue loss under the superior level of metatarsus (Rutherford class4 or5); 4) being anatomically unsuitable for surgery or an endovascular intervention or showing no improvement for at least 3 months following surgery or an endovascular intervention; 5) if present, unrelieved rest pain or a woundsize that was not reduced after at least 1 month of medical treatment; 6) complete baseline data and known status of survival, amputation, wound healing and rest pain relief at 6 months after transplantation; 7)A consent form been signed.
Exclusion criteria
Exclusion criteria: 1) serious health events <3 months before admission, including but not limited to a myocardial infarction, cerebral apoplexy, a pulmonary embolism, severe hepatic and renal dysfunction; 2) a diagnosis of malignancy at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major amputation;Major amputation-free survival;Complete remission of critical limb ischemia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing;Wong-Baker pain scale;Ankle-brachial index;Transcutaneous oxygen pressure; | — |
Countries
China
Contacts
Public ContactWeiguo Fu
Zhongshan Hospital, Fudan University
Outcome results
None listed