Chronic critical limb ischemia (peripheral arterial disease, Buerger disease)
Conditions
Interventions
Intervention type:DEVICE,PROCEDURE
Name of intervention:Intramuscular transplantation of CD34+ cells
Dose form / Japanese Medical Device Nomenclature:OTHER
Route of administration / Site of applicatio
Sponsors
Atsuhiko Kawamoto
Takayuki Asahara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with infra-inguinal atherosclerosis with a stenosis (>70%), or occlusion (100%) of a major vessel in the affected limb(s) (demonstrated by diagnostic angiography) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries. 2) At least 6 months since the onset of CLI (Chronic PAD) 3) Patients whose Rutherford's category is 4 or 5. 4) Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/ restenosis following the traditional revascularization. 5) Age is between 20 and 80. 6) Patients who can give informed consent themselves in writing.
Exclusion criteria
Exclusion criteria: 1) Patients whose Rutherford's category is 6. 2) Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 months preceding screening. 3) Patients whose left ventricular ejection fraction by echocardiography < 25% 4) Patients with a history of severe allergic reactions or side effects to G-CSF preparations, apheresis or Isolex-relating reagents. 5) Patients with a history of allergic reactions or side effects to mouse, rat or bovine-derived proteins. 6) Patients with malignant tumor or a history of malignant tumor within 5 years. 7) Patients with diabetic proliferating retinopathy (new Fukuda classification BII to BV). 8) Less than 3 months since last episode of unstable angina or myocardial/cerebral infarction. 9) Patients with end stage renal disease on maintenance hemodialysis. 10) Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes). 11) Patients with autoimmune disease. 12) Patients who cannot discontinue Warfarin. 13) Patients with cirrhosis of the liver. 14) Patients currently suffering from or having a history of interstitial pneumonitis. 15) Patients with cerebral aneurysm indicative for surgical/ endovascular treatment by neurosurgeon. 16) Leukocytes less than 4,000/mcL or exceeding 15,000/mcL. 17) Platelets less than 100,000/mcL. 18) Hemoglobin less than 8 g/dL. 19) AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L. 20) Patients for whom abdominal CT or ultrasonography reveals splenomegaly. 21) Patients with rest pain or ulcer/ gangrene in the legs due to neural, joint or autoimmune diseases except PAD and Buerger disease. 22) Patients for whom major amputation of the lower extremity is indicated because of the severity of the tissue damage and functional aspects after amputation. 23) Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Explore the following endpoints: 1) Rutherford category & Fontaine class, 2) Wong Baker FACES pain rating scale, VAS, Rest pain scale, 3) Health-relating QOL, 4) Area of ulcer/ gangrene, 5) ABPI, TBPI, SPP, TcPO2, ACD & ICD, 6) major amputation, death due to CLI or other cardiovascular events and 7) device performance. | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A because of the exploratory nature of this study | — |
Countries
Japan
Contacts
Public ContactMaki Shibakawa
Institute of Biomedical Research and Innovation
Outcome results
None listed