chronic kidney disease
Conditions
Sponsors
Ohtake Takayasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with chronic kidney disease. 2) Patients who are undergoing medical and diet treatment for chronic kidney disease. 3) Patients with CKD stage G3b~G4 and progressive kidney dysfunction under standard medical and diet treatment. 4) Patients aged 20~80 years old. 5) Patients with written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients without data of kidney function within preceding 12 months. 2) Patients who are admitting in hospital. 3) Dialysis patients. 4) Past history of renal transplantation (both recipient and donor). 5) Single kidney or single functioning kidney. 6) Patients who underwent contrast media-enhanced imaging test or catheter angiography/intervention within recent 1 month. 7) Patients who underwent surgical treatment within recent 1 month. 8) Severely damaged cardiac function (EF<25%). 9) Allergic reaction to G-CSF, apheresis. 10) Allergic reaction to mouse anti CD34 antibody in reagents. 11) Malignancy or past history within past 5 years. 12) Diabetic proliferating retinopathy. 13) Within 3 months from angina pectoris, myocardial infarction, or stroke. 14) Leukemia, myeloproliferative disorder, myelodysplastic syndrome, sickle cell anemia. 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 10,000/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 HTLV1. 26) Participant of other clinical study. 27) Patients who are judged not to be appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety for 24 weeks after the first cell transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes of serum creatinine, eGFR, urinary data, abdominal ultrasonography after first cell transplantation. 2) Renal events (doubling of serum creatinine, dialysis initiation, renal transplantation, eGFR decline more than 30% from baseline value). 3) Changing rate of reciprocal creatinine and eGFR before and after cell transplantation. 4) Survival rate, and death and cause of death during 24 weeks after first cell transplantation. 5) Cell purity and viability. 6) Number of CD34+ cells, cell population, EPC-CFU and extracellular vesicle before and after Quality and Quantity culture. | — |
Countries
Japan
Contacts
Public ContactYuko Mizushima
Shonan Kamakura General Hospital
Outcome results
None listed