Arteriosclerosis obliterans Buerger'
Conditions
Interventions
Intramuscular injection of Growth Factor (FGF) containing solution
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with ASO or Buerger's disease (2) Patient whose Fontaine classification is 3-4 and Rutherford classification is 4-6 in either limb. (3) Patients with clinical improvement can not be obtained even after any existing medical and surgical treatment. (4) Patient who can receive the protocol treatment for either limb. (5) Patients who can give informed consent themselves in writing.
Exclusion criteria
Exclusion criteria: (1) Patients with life expectancy likely to be within one year due to complications. (2) Patients are scheduled for major lower limb amputation (3) Patients with angina, congestive heart failure, or ventricular arrhythmia requiring treatment. (4) Patients with myocardial infarction within three months. (5) Left ventricular ejection fraction below 25% (6) Patients with lower extremity revascularization within 3 months. (7) Patient who performed percutaneous coronary intervention, bypass surgery within 1 month. (8) Hemoglobin 7 g /dL or less (9) Platelet count 70,000 / uL or less (10) AST 100 IU or more, or ALT 100 IU or more (11) Patients with malignant neoplasm requiring treatment. (12) Patients with suspected infection and fever. (13) Patients with uncontrolled diabetes over HbA1c 10%. (14) Patients with diabetic proliferating retinopathy requiring treatment. (15) Alprostadil Alfadex (for injection), Alprostadil (injection solution), Argatroban (injection solution), Trafermin (recombinant) in patients who are difficult to stop the worsening of symptoms could be stopped before surgery preparation. (16) Patients with a history of severe drug allergy. (17) Patients with negative skin reaction to decision not test solution. (18) The females who are in pregnancy or lactation, may be pregnant, or are planning. (19) Patients with a history of alcohol or drug dependence in past year. (20) Patients who are considered unsuitable by other principal investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation for Incidence, Severity, and Seriousness of adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of Fontaine and Rutherford Classification | — |
Countries
Japan
Contacts
Public ContactSatoaki Matoba
Kyoto Prefectural University of Medicine Department of Cardiovascular Medicine
Outcome results
None listed