Vascular regeneration therapy by transplantation of autologous peripheral blood CD34+ cells in patients with chronic critical limb ischemia - TRIASO0704

Atsuhiko Kawamoto0 sites11 target enrollmentSeptember 25, 2008

Overview

Phase: 未知
Intervention: Not specified
Conditions: Chronic critical limb ischemia (peripheral arterial disease, Buerger disease)
Sponsor: Atsuhiko Kawamoto
Enrollment: 11
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

September 25, 2008

End Date

June 30, 2011

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Atsuhiko Kawamoto

•1\) Patients with infra\-inguinal atherosclerosis with a stenosis (\>70%), or occlusion (100%) of a major vessel in the affected limb(s) (demonstrated by diagnostic angiography) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries.
•2\) At least 6 months since the onset of CLI (Chronic PAD)
•3\) Patients whose Rutherford's category is 4 or 5\.
•4\) Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/ restenosis following the traditional revascularization.
•5\) Age is between 20 and 80\.
•6\) Patients who can give informed consent themselves in writing.

•1\) Patients whose Rutherford's category is 6\.
•2\) Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 months preceding screening.
•3\) Patients whose left ventricular ejection fraction by echocardiography \< 25%
•4\) Patients with a history of severe allergic reactions or side effects to G\-CSF preparations, apheresis or Isolex\-relating reagents.
•5\) Patients with a history of allergic reactions or side effects to mouse, rat or bovine\-derived proteins.
•6\) Patients with malignant tumor or a history of malignant tumor within 5 years.
•7\) Patients with diabetic proliferating retinopathy (new Fukuda classification BII to BV).
•8\) Less than 3 months since last episode of unstable angina or myocardial/cerebral infarction.
•9\) Patients with end stage renal disease on maintenance hemodialysis.
•10\) Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).