CD34+ cell transplantation for patients with acute renal failure.

Phase 1

Recruiting

• Conditions: Acute renal failure; acute renal failure

• Registration Number: JPRN-jRCTb030190231
• Lead Sponsor: OHTAKE Takayasu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 9

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1) Patients with acute renal failure who require hemodialysis or who have withdrawn from hemodialysis but do not recover to normal renal function within 4 weeks after the onset of acute renal failure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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified