Autologous peripheral blood-derived CD34+ cell transplantation for acute kidney injury.

Phase 1

• Conditions: acute kidney injury

• Registration Number: JPRN-UMIN000031691
• Lead Sponsor: Kidney Disease and Transplant Center, Shonan Kamakura General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-26
• Study Completion: 2020-03-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety for 52 weeks after cell transplantation (adverse events, adverse effects according to CTCAE)

Secondary Outcome Measures

Name	Time	Method
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