G-CSF mobilized autologous CD34+ cell transplantation as regenerative medicine for patients with acute renal failure.

OHTAKE Takayasu0 个研究点目标入组 9 人开始时间: 2020年2月27日最近更新: 2023年10月17日

试验速览

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•1) Patients with acute renal failure who require hemodialysis or who have withdrawn from hemodialysis but do not recover to normal renal function within 4 weeks after the onset of acute renal failure
•2) Patient with urinary N-GAL 104 micro g/L or more, or 130 micro g/g creatinine or more
•3) Patients who gave written informed consent
•4) Patients who are clinically determined as acute renal failure by clinical course of events and image findings

•1) Shock vital.
•2) Respiratory failure who require mechanical ventilation.
•3) Pre-renal or post-renal acute renal failure
•4) Receiving steroid therapy for disorders other than kidney disease (except local administration)
•5) Maintenance hemodialysis or peritoneal dialysis
•6) Past history of renal transplantation
•7) Severely damaged cardiac function (EF<25%)
•8) Allergic reaction to G-CSF, apheresis
•9) Allergic reaction to mouse anti CD34 antibody in reagents
•10) Malignancy or past history within past 5 years
•11) Diabetic proliferating retinopathy
•12) Within 3 months from angina pectoris, myocardial infarction, or stroke
•13) Leukemia, myeloproliferative disorder, myelodysplastic syndrome, sickle cell anemia
•14) Autoimmune disease
•15) Liver cirrhosis
•16) Interstitial pneumonia
•17) Cerebral arterial aneurysm which need treatment
•18) White blood cell count under 3,000/micro L or over 15,000/micro L
•19) Platelet count under 50,000/micro L
•20) Hemoglobin under 8g/dL
•21) AST (GOT) or ALT (GPT) 100 IU/L or over
•22) Albumin under 2g/dL
•23) Splenomegaly 15 cm or Larger in its longest diameter on CT imaging
•24) Pregnant
•25) Patient of HBV, HCV, HIV or HTLV-1
•26) Participant of other clinical study
•27) Single kidney
•28) Patients who are judged not to be appropriate to participate in this study

发起方

OHTAKE Takayasu