CD34+ cell transplantation for patients with chronic kidney disease

G-CSF-mobilized peripheral blood-derived autologous CD34+ cell transplantation for patients with chronic kidney disease

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTb030240024

Enrollment

Registered

2024-04-11

Start date

2024-06-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

After G-CSF s.c. (400 micro g/kg) for 5 days, peripheral blood mononuclear cells will be separated. At day 6, CD34+ cells will be separated using CliniMACS system. Purified CD34+ cells will be injecte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with chronic kidney disease. 2) Patients with CKD stage G3a~G5 (not on dialysis). 3) Patients who are 18 years or older and are able to live independently. 4) Patients with written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients who are admitting in hospital. 2) Dialysis patients. 3) Allergic reaction to G-CSF, apheresis. 4) Allergic reaction to mouse anti CD34 antibody in reagents. 5) Severe allergic reaction to contrast agent. 6) Malignancy or past history within past 5 years. 7) Diabetic proliferating retinopathy. 8) Within 3 months from angina pectoris, myocardial infarction, or stroke. 9) Leukemia, myeloproliferative disorder, myelodysplastic syndrome, sickle cell anemia. 10) Liver cirrhosis. 11) Interstitial pneumonia. 12) Cerebral arterial aneurysm which need treatment. 13) Hydronephrosis. 14) Gross hematuria. 15) White blood cell count under 3,000/micro L or over 10,000/micro L. 16) Platelet count under 50,000/micro L. 17) Hemoglobin under 8g/dL. 18) AST (GOT) or ALT (GPT) 100 IU/L or over. 19) Albumin under 2g/dL. 20) Splenomegaly 15 cm or Larger in its longest diameter on CT imaging. 21) Pregnant. 22) Patient of HBV, HCV, HIV or HTLV1. 23) Patients who are judged not to be appropriate to participate in this study.

Design outcomes

Primary

Measure	Time frame
Safety and efficacy (changes of serum creatinine, eGFR, urinary data during 24 weeks after the first cell transplantation; renal events (doubling of serum creatinine, dialysis initiation, renal transplantation, eGFR decline more than 30% from baseline value); changing rate of reciprocal creatinine and eGFR before and after cell transplantation)	—

Secondary

Measure	Time frame
Efficacy (survival rate, and death and cause of death during 24 weeks after the first cell transplantation), cell purity and viability; number of CD34+ cells, cell population, EPC-CFU and extracellular vesicle before and after Quality and Quantity culture, and the analysis of protein expression (comprehensive proteomics) using blood and urine samples.	—

Countries

Japan

Contacts

Public ContactNorimasa Harada

Shonan Kamakura General Hospital

ccts512@shonankamakura.or.jp+81-467-46-1717

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026