CLI (Atherosclerotic PAD/Buerger disease )
Conditions
Interventions
Subcutaneous administration of G-CSF, Harvest and implantation of PB-MNC
Sponsors
Regenerative Medicine Unit, Division of Vascular Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aherosclerotic PAD or Buerger's disease with >70% luminal stenosis in the leg arteries by digital subtraction angiography(DSA) 2) >3 months since the onset of lower limb ischemia 3) CLI within category 4-5 on the Rutherford's scale 4) Failure of or no indication for transluminal angioplasty/stenting and bypass surgery 5) 20-80 old patients who can give informed consent themselves in writing
Exclusion criteria
Exclusion criteria: 1) CLI within category 6 on the Rutherford's scale 2) Less than 3 months since success of bypass surgery, transluminal angioplasty and sympathectomy for the limb expected to be transplanted 3) Left ventricular ejection fraction < 25% 4) Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis 5) Patients with malignant tumor 6) Patients with diabetic proliferating retinopathy (new Fukuda classification ii to BV) 7) Less than 3 months since last episode of unstable angina and myocardial/cerebral infarction 8) Patients with hematological disease (leukemia, myeloproliferative disease, myelodysplastic syndromes or sickle cell anemia) 9) Patients with collagen diseases 10) Patients with cirrhosis of the liver 11) Patients currently suffering from or having a history of interstitial pneumonitis 12) Patients with cerebral aneurysm judged to require treatment by a neurosurgeon 13) Leukocytes less than 4,000/micro L or exceeding 15,000/micro LL 14) Platelets less than 100,000/micro L 15) Hemoglobin less than 8 g/dL 16) AST(GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L 17) Patients for whom abdominal CT reveals splenomegaly 18) Patients with rest pain, ulcer or necrosis for reasons other than CLI (such as lumber spinal canal stenosis, arthropathy or vasculitis), 19) Patients who require major amputation regardless of whether revascularization is successful or not, because of exposure of the bone or tendon due to osteomyelitis, osteonecrosis, ulcer and soft tissue necrosis, or sepsis 20) Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period 21) Patients enrolled in any other clinical trial 22) Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will exploratorily evaluate the following concerns without configuring primary outcomes. 1) Fontaine's grade and Rutherford's category 2) All-cause mortality and cause of death 3) Major amputation and unplanned minor amputation 4) Size of ulcer 5) Severity of ischemic leg pain 6) Physiological findings of lower extremity ischemia | — |
Countries
Japan
Contacts
Public ContactTomoko Ito
Institute of Biomedical Research and Innovation (IBRI) Department of Clinical Trial Support
Outcome results
None listed