Therapeutic angiogenesis by cell transplantation using dedifferentiated fat (DFAT) cells.
- Conditions
- critical limb ischemia
- Registration Number
- JPRN-jRCTb030190212
- Lead Sponsor
- Tanaka Masashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 4
(1) Critical limb ischemia (CLI) patients caused by atherosclerosis obliterans (ASO) with luminal obstruction or stenosis determined by leg angiography, MRA, or CTA
(2) Patients fulfilling any one of the following criteria in the target limb
Ankle systolic blood pressure < 60 mmHg
Toe systolic blood pressure < 40 mmHg
tcPO2 <50 mmHg
SPP <50 mmHg
(3) Patients who are categorized to Rutherford Category 4 or 5 in the target limb
(4) Sustained symptoms of CLI (Rutherford Category 4 or 5) for more than 2 weeks at the time of obtaining consent
(5) Patients whom angioplasty and bypass surgery are not indicated in the target limb or patients who are still categorized to Rutherford Category 4 or 5 following the conventional revascularization
(6) Patients who can give informed consent themselves or witnesses in writing
(1) Acute worsening of Rutherford Category in the target limb within 1 month prior to registration
(2) SVS WIfI Stage > 3 in the target limb
(3) Patients requiring major amputation of the target limb at the time of obtaining consent or prior to registration
(4) Patients who are received angioplasty, bypass surgery, other surgical procedure, or LDL apheresis in the target limb within 1 month prior to obtaining consent
(5) Patients with inadequate inflow to the popiliteal artery of the target limb due to obstruction of iliac artery, common femoral artery, or both superficial and deep femoral arteries
(6) Patients with gait disturbance, rest pain, skin ulcer/necrosis for reasons other than ASO
(7) Patients with severe neural disorder in the target limb
(8) Myocardial infarction, brain infarction, brain hemorrhage, or TIA within 6 months prior to obtaining consent
(9) Presence of poorly controlled ischemic heart disease, heart failure, and arrythmia
(10) Patients with diabetic proliferating retinopathy (new Fukuda classification B1 to B5)
(11) Patients who have evidence or history of malignant tumor within 5 years prior to obtaining consent
(12) Patients tested positive for HBs antigen, HCV antibody, HTLV-1 antibody, and syphilis serum reaction
(13) Patients with a history of severe allergic reactions or side effects to bovine-derived proteins
(14) Any other reason that the Clinical Supervisors may have for considering a case unstable for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method