Critical limb ischemia with pain and ulcer in patients undergoing hemodialysis
Conditions
Interventions
Intra-muscular injection of G-CSF mobilized autologous CD34+ cell from peripheral blood collected by apheresis
Sponsors
OHTAKE Takayasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy evaluation of the therapy for 52 weeks Safety: all adverse events Efficacy: proportion of incident of major or unexpected amputation, amputation free survival (AFS) and comparison about one-year AFS with the former study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Improvement assesses by Fontaine stage and proportion of the stage 2 or under 2) Improvement assessed by Rutherford category and proportion of the category 3 or under 3) Pain: visual analogue scale, rest pain scale 4) Ulcer and necrosis 5) Physiological tests (ankle brachial pressure index, toe brachial pressure index, skin perfusion pressure, transcutaneous partial oxygen pressure, absolute and initial claudication distance) 6) Critical limb ischemia free survival 7) Overall survival 8) Major cardiovascular event-free survival 9) Proportion of the cases of transplantation with insufficient number of CD34+ cells under 10^5/kg based on the patients or the limbs 10) Efficiency of CliniMACS including purity, viability and recovery of CD34+ cells, and malfunctions of CliniMACS | — |
Countries
Japan
Contacts
Public ContactNorimasa Harada
Shonan Kamakura General Hospital
Outcome results
None listed