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Kidney Week

Abstract: SA-PO347

A Clinical Trial of Comprehensive Regenerative Treatment for Acute and Chronic Kidney Injury by Autologous Granulocyte-Colony Stimulating Factor (G-CSF)-Mobilized Peripheral Blood-Derived CD34+ Cell Administration

Session Information

Category: Development, Stem Cells, and Regenerative Medicine

  • 600 Development, Stem Cells, and Regenerative Medicine

Authors

  • Ohtake, Takayasu, Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan
  • Mochida, Yasuhiro, Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan
  • Ishioka, Kunihiro, Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan
  • Oka, Machiko, Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan
  • Hidaka, Sumi, Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan
  • Kobayashi, Shuzo, Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan
Background

There has been no established treatment to improve severe acute kidney injury (AKI) and progressive chronic kidney disease (CKD) in human. We are performing a clinical trial of regenerative medicine using autologous G-CSF-mobilized CD34+ cells for AKI and CKD.

Methods

After permission of government permitted ethical committee, a clinical trial of regenerative treatment for severe AKI and progressive CKD is now undergoing. Potential subjects comprised of patients with dialysis-dependent severe AKI or patients who could fortunately be withdrawn from dialysis treatment but did not recover to baseline renal function within 4 weeks after the onset of AKI (AKI arm), and patients with progressive CKD (CKD stage G3b and G4 with decrease of reciprocal serum creatinine more than 0.01mL/mg/month) (CKD arm). Autologous G-CSF-mobilized peripheral blood-derived CD34+ cells at a dose of 1x106/kg body weight were administered into renal arteries, and safety and efficacy were evaluated.

Results

Until now, six patients (2 AKI patients with malignant hypertension and 4 CKD patients with IgA nephropathy) were registered, and 4 patients (2 AKI patients and 2 CKD patients) completed their follow-up after cell therapy. As for safety, no major adverse events were observed. AKI case 1 showed rapid increase of estimated glomerular filtration ratio (eGFR) from 9.2 at transplantation to 20.0 mL/min/1.73m2 at 4 weeks after cell therapy, and further improved to 24.9mL/min/1.73m2 at 52 weeks. AKI case 2 could be withdrawn from hemodialysis treatment one month after cell transplantation, and eGFR gradually increased to 12.8 mL/min/1.73m2 at 52 weeks. eGFR in CKD case 1 decreased from 15.0 at transplantation to 10.2 mL/min/1.73m2 at 6 months after cell therapy. However, eGFR in CKD case 2 increased from 15.2 at transplantation to 17.5 mL/min/1.73m2 at 6 months after cell therapy. CKD case 3 and 4 are now under follow-up period.

Conclusion

Regenerative cell therapy using autologous G-CSF-mobilized CD34+ cells might have beneficial effect in patients with severe AKI. In progressive CKD patients with severely decreased renal function, further patients’ recruitment and clarification of the efficacy of this cell therapy is necessary.