Acute renal failure acute renal failure
Conditions
Interventions
After G-CSF s.c. (10 micro g/kg, QD) for 5 days, peripheral blood mononuclear cells will be separated. At day 6, CD34+ cells will be separated using CliniMACS system. Purified CD34+ cells will be inje
granulocyte colony-stimulating factor, G-CSF, CD34, cell therapy
Sponsors
OHTAKE Takayasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with acute renal failure who require hemodialysis or who have withdrawn from hemodialysis but do not recover to normal renal function within 4 weeks after the onset of acute renal failure 2) Patient with urinary N-GAL 104 micro g/L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
Exclusion criteria
Exclusion criteria: 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) Liver cirrhosis 15) Interstitial pneumonia 16) Cerebral arterial aneurysm which need treatment 17) White blood cell count under 3,000/micro L or over 15,000/micro L 18) Platelet count under 50,000/micro L 19) Hemoglobin under 8g/dL 20) AST (GOT) or ALT (GPT) 100 IU/L or over 21) Albumin under 2g/dL 22) Splenomegaly 15 cm or Larger in its longest diameter on CT imaging 23) Pregnant 24) Patient of HBV, HCV, HIV or HTLV-1 25) Participant of other clinical study 26) Single kidney 27) Patients who are judged not to be appropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety for 52 weeks after cell transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Withdrawal rate from hemodialysis at 2, 4, 12, 26, 52 weeks after cell transplantation. 2) Change of serum creatinine, eGFR, urine test value, and abdominal echo findings until 52 weeks after cell transplantation. 3) Death and death cause during 52 weeks after cell transplantation. 4) Cell separation, purity, and viability. | — |
Countries
Japan
Contacts
Public ContactNorimasa Harada
Shonan Kamakura General Hospital
Outcome results
None listed