acute kidney injury
Conditions
Interventions
After G-CSF s.c. (5 ug/kg) for 5 days, peripheral blood mononuclear cell will be separated. At day 6, CD34+ cells will be separated using CliniMACS system. Purified CD34+ cells will be injected via bi
Sponsors
Kidney Disease and Transplant Center, Shonan Kamakura General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patients with acute renal failure who require hemodialysis. 2) patient with urinary N-GAL 104 ug/g creatinine or more 3) patients who gave written informed consent 4) patients who have data of renal function within 12 months prior to inclusion
Exclusion criteria
Exclusion criteria: 1) shock vital. 2) respiratory failure who require mechanical ventilation. 3) pre-renal or post-renal acute renal failure 4) maintenance dialysis (HD or PD) 5) severely damaged cardiac function (EF<25%) 6) allergic reaction to GCSF, apheresis, or mouse anti CD34 antibody 7) past history of renal transplantation 8) malignancy or past history within past 5 years 9) diabetic proliferating retinopathy (B2 or more) 10) within 3 months from angina pectoris, myocardial infarction, or stroke 11) leukemia, myelo-proliferating disease, myelodyslastic syndrome, sickle cell anemia 12) autoimmune disease 13) liver cirrhosis 14) interstitial pneumonia 15) brain aneurysm which need treatment 16) white blood cell count <3000/uL or >15000/uL 17) platelet count <50000/uL 18) hemoglobin < 8 g/dL 19) AST or ALT >100 IU/L 20) albumin < 2g/dL 21) splenomegaly on CT imaging 22) pregnant woman 23) patients who have HBV, HCV, HIV, HTLV1 24) single kidney 25) patients who join other clinical study 26) 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 (adverse events, adverse effects according to CTCAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) withdrawal rate from hemodialysys at 2, 4, 12, 26, 52 weeks after cell transplantation. 2) change of serum creatinine, eGFR, and urinary 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 ContactTakayasu Ohtake
Shonan Kamakura General Hospital Kidney Disease and Transplant Center
Outcome results
None listed