CD34+ cell transplantation for patients with chronic kidney disease

Phase 1

• Conditions: chronic kidney disease

• Registration Number: JPRN-jRCTb030210237
• Lead Sponsor: Ohtake Takayasu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-12
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified