G-CSF mobilized autologous CD34+ cell transplantation as regenerative medicine for patients with critical limb ischemia.

OHTAKE Takayasu0 个研究点目标入组 20 人开始时间: 2019年11月27日最近更新: 2023年10月17日

试验速览

暂无简介。

•1) Atherosclerotic peripheral arterial disease with greater than or equal to 70% luminal stenosis or obstruction in the leg arteries by digital subtraction angiography
•2) Undergoing hemodialysis
•3) More than 12 weeks since the onset of lower limb ischemia
•4) Rutherford category of 4-5
•5) Failure of or no indication for transluminal angioplasty/stenting and bypass surgery

•1) Rutherford category of 6
•2) Buerger's disease
•3) Within 4 weeks after revascularization therapy (bypass surgery or endovascular therapy) or low-density lipoprotein apheresis
•4) Severely decreased cardiac function (under 25% of left ventricular ejection fraction on cardiac ultrasonography)
•5) Allergic reaction or adverse reaction to G-CSF, the other reagents, or apheresis
•6) Malignancy or history of malignancy within past 5 years
•7) Advanced Diabetic retinopathy
•8) Within 12 weeks after myocardial infarction, unstable angina pectoris, or stroke
•9) Hematologic disease (leukemia, myeloproliferative disorders, myelodysplastic syndromes, or sickle cell disease)
•10) Autoimmune disorders
•11) Liver cirrhosis
•12) Interstitial pneumonitis or history
•13) At least one laboratory abnormality (white blood cell count, under 3,000 /micro L or greater than 15,000/micro L; hemoglobin concentration, under 8 g/dL; platelet count, under 100,000/micro L; aspartate aminotransferase or alanine aminotransferase, equal or greater than 100 IU/L; and serum albumin, under 2 g/dL)
•14) Splenomegaly 15 cm or larger in its longest diameter on computed tomography
•15) Pregnancy

发起方

OHTAKE Takayasu