Status:
COMPLETED
Stem Cell Study for Patients With Leg Ulcer/Gangrene
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital
Conditions:
Leg Pain
Ulcer
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be ...
Detailed Description
Chronic critical limb ischemia (CLI) is a progressive disease, which arises as a result of atherosclerosis or vasculitis in leg arteries. Prognosis of chronic CLI is poor, and no effective treatments ...
Eligibility Criteria
Inclusion
- Chronic severe CLI patients fulfilling all the following criteria are considered suitable for inclusion in the study.
- At least 6 months since the onset of CLI (Chronic peripheral artery disease or Buerger disease)
- Patients with luminal stenosis \> 50% by leg angiography
- Age is between 20 and 80.
- Patients whose Rutherford's class is II-4, III-5, or III-6（Patients with rest pain or ischemic ulcer/necrosis)
- Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/ restenosis following the traditional revascularization (No option patients)
- Patients who can give informed consent themselves in writing.
Exclusion
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- Left ventricular ejection fraction \< 25%
- Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis.
- Less than 6 months since last episode of myocardial/cerebral infarction.
- Patients with unstable angina, with a treatment rating of 3 in the Braunwald system, but a severity of III and a clinical rating of B or C.
- Patients with diabetic proliferating retinopathy (new Fukuda classification BI to BV).
- Patients with malignant tumor
- Patients with chronic rheumatoid arthritis.
- Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
- Patients currently suffering from or having a history of interstitial pneumonitis.
- Patients for whom cranial MRA reveals cerebral aneurysm.
- Patients for whom abdominal CT or ultrasonography reveals splenomegaly.
- Patients with cirrhosis of the liver.
- Patients who cannot discontinue Warfarin.
- Leukocytes less than 4,000/µL or exceeding 10,000/µL.
- Platelets less than 100,000/µL.
- Hemoglobin less than 10 g/dL.
- AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
- Patients with severe neural disorder in their legs.
- Patients with gait disturbance for reasons other than CLI (such as sciatic neuralgia, or vasculitis), making exercise tolerance evaluation on a treadmill with stress ECG difficult.
- Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00221143
Start Date
November 1 2003
End Date
January 1 2008
Last Update
February 9 2009
Active Locations (2)
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1
Kobe City General Hospital
Kobe, Hyōgo, Japan, 650-0046
2
Institute of Biomedical Research and Innovation
Kobe, Hyōgo, Japan, 650-0047