critical limb ischemia
Conditions
Interventions
Intramuscularly injection of autologous dedifferentiated fat (DFAT) cells into ischemic limb
Sponsors
Tanaka Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of intramuscular injection of DFAT cells Number and ratio of participants with adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of intramuscular injection of DFAT cells Time frame: 4, 12, 24, 36, and 52 weeks (1)Changes in Fontaine and Rutherford classification (2)Ratio of recovery from CLI (3)Changes in ulcer/necrosis healing (4)Changes in ischemic leg pain assessment by visual analogue scale (VAS) (5)Changes in ABI, TBI, SPP, and tcPO2 (6)Changes in clinical stages by SVS WIfI classification system (7)Changes in ACD and ICD as measured by 6-minute walk test (8)Survival time (9) Major amputation-free survival and amputation-free survival | — |
Countries
Japan
Contacts
Public ContactMitsuhiro Matsunaga
Nihon University
Outcome results
None listed