Transplantation of autologous mononuclear cells in patients with critical limb ischemia (CLI)
- Conditions
- CLI (atherosclerotic PAD/Buerger disease)
- Registration Number
- JPRN-UMIN000005232
- Lead Sponsor
- Regenerative Medicine Unit, Division of Vascular Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Not provided
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 side effects to apheresis 5) Patients with malignant tumor 6) Patients with diabetic proliferating retinopathy (new Fukuda classification Bii to BV) 7) Less than 3 months since last episode of unstable angina and myocardial/cerebral infarction 8) Patients with cirrhosis of the liver 9) Leukocytes exceeding 15,000/ micro L 10) Platelets less than 100,000/ micro L 11) Hemoglobin less than 8 g/dL 12) Patients with rest pain, ulcer or necrosis for reasons other than CLI (such as lumber spinal canal stenosis, arthropathy or vasculitis) 13) 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 14) Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period 15) Patients enrolled in any other clinical trial 16) Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method