G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with critical limb ischemia.
- Conditions
- Critical limb ischemia in patients undergoing hemodialysis
- Registration Number
- JPRN-UMIN000037339
- Lead Sponsor
- Center for Clinical and Translational Science, Shonan Kamakura General Hospital, Tokushukai Medical Group.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1
Not provided
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 on computed tomography 15) Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and efficacy evaluation of the therapy for 52 weeks
- Secondary Outcome Measures
Name Time Method