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Kidney Week

Abstract: PO0559

Role of Adipose Tissue-Derived Mesenchymal Stem Cells in CKD: A Phase 1 Study Assessing Safety and Clinical Feasibility

Session Information

Category: CKD (Non-Dialysis)

  • 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Author

  • Cai-Mei, Zheng, Taipei Medical University College of Medicine, Taipei, Taiwan
Background

Chronic kidney disease (CKD) is a most common progressive disorder associated with high mortality and huge socio-economic burden globally. We hypothesize that allogeneic adipose tissue mesenchymal stromal cells (hASCs) are renotropic and may retard CKD progression through anti-apoptotic, anti-fibrotic, and anti-inflammatory effects. In this study, we will assess the safety and tolerability of a hASCs infusion in CKD patients with various underlying etiologies.

Methods

We performed a single-arm phase I clinical trial with a 6-month follow-up. This study enrolled 12 eligible CKD patients with an estimated glomerular filtration rate (eGFR) of 15-44 mL/min/1.73m2 (mL/min). Patients were allocated to receive low, moderate, or high dose of allogeneic cultured hASCs infusion. We investigated the safety issues and kidney function during the follow-up visits.

Results

There was no patient lost to follow-up. We observed two treatment related adverse events (AE) in high dose group. One subject experienced grade 1 slow speech immediately after hASCs infusion, which was resolved on the next day and completely normal afterwards. The AE was considered possibly related to study treatment and met dose-limiting toxicity (DLT). Another subject experienced grade 1 bradyphrenia after the infusion, and the situation was resolved during the following 9 days, however, this AE was not considered as DLT. One SAE was reported in moderate dose group, who was hospitalized for persistent heavy proteinuria, and later proved as diabetic nephropathy stage 4 by renal biopsy. No significant reduction in eGFR was noted among all treated patients, and specifically an improvement in eGFR was noted among those with baseline eGFR>30mL/min. No significant reduction in proteinuria was noted.

Conclusion

This trial demonstrated the safety and tolerability of allogenic hASCs infusion in stages 3b and 4 CKD patients. Patients with reserved renal function (e.g. eGFR>30mL/min) could be more beneficial from hASCs compared to those without. hASCs efficacy and dosing interval in various CKD stages should be investigated in future randomized placebo-controlled trial among various CKD population.