Clinical efficacy and safety of allogeneic adipose-derived stem cells ELIXCYTE in chronic kidney disease: a phase I/II study.

Chronic kidney disease (CKD) poses a significant global health burden by reducing quality of life and increasing mortality. Current therapies remain inadequate in halting its progression, necessitating novel treatments to improve outcomes. Adipose-derived stem cells (ADSCs) have emerged as a promising therapeutic option. Phase I/II clinical trials evaluated the efficacy, safety, and tolerability of ELIXCYTE in slowing CKD progression. This multicenter, randomized, open-label study monitored estimated glomerular filtration rate (eGFR) changes over a 48-week period following a single intravenous infusion of ADSCs. Participants were allocated to one of three dosage groups, with primary outcomes assessing eGFR changes and secondary outcomes focusing on safety and tolerability. Results confirmed a favorable safety profile, with no dose-limiting toxicities observed in the low- and moderate-dose groups. Group-based trajectory modeling (GBTM) indicated that, overall, 88.24% of patients exhibited a trend of improvement or stabilization. In the low-dose group, 72.23% of patients demonstrated a stable trend, which was more consistent than in other dosage groups. Furthermore, patients with CKD stage 3B showed a numerically higher proportion of improving trajectories compared to those with stage 4 disease. The low-dose ADSC group exhibited a trend toward more favorable renal function trajectories and fewer adverse events than higher doses, suggesting that lower dosing may provide a balanced profile of safety and potential efficacy. However, despite the preliminary results indicating that ELIXCYTE may effectively slow CKD progression, further large-scale clinical trials are necessary to corroborate these findings and verify the efficacy of ADSC treatment.