Allogeneic adipose tissue-derived stem cells ELIXCYTE^® in chronic kidney disease: A phase I study assessing safety and clinical feasibility

The purpose of this phase I clinical trial is to assess the safety and tolerability of allogeneic adipose tissue-derived stem cells (ADSCs) among chronic kidney disease (CKD) patients. 12 eligible CKD patients with an estimated glomerular filtration rate (eGFR) of 15–44 ml/min/1.73 m² received one dose of intravenous allogeneic ADSCs (ELIXCYTE^®), as 3 groups: 3 low dose (6.4 × 10⁷ cells in total of 8 ml), 3 middle dose (19.2 × 10⁷ cells in total of 24 ml) and 6 high dose (32.0 × 10⁷ cells in total of 40 ml) of ELIXCYTE^® and evaluated after 48 weeks. Primary endpoint was the safety profiles in terms of incidence of adverse events (AEs) and serious adverse event (SAE). Two subjects in high dose group experienced a total of 2 treatment-related AEs which are Grade 1 slow speech and Grade 1 bradyphrenia after the infusion. One subject in middle dose group experienced an SAE unlikely related to treatment, grade 2 proteinuria. No fatal AE was reported in this study. An increase in eGFR was observed in 7 out of 12 subjects (58%) at Week 24 and in 6 of 12 subjects (50%) by Week 48. By Week 24, an increase in eGFR by more than 20% among all CKD patients with baseline eGFR ≧ 30 ml/min/1.73 m² as compared to only 2 subjects in baseline eGFR < 30 ml/min/1.73 m² group. No significant reduction in proteinuria was noted among all subjects. This phase I trial demonstrated single-dose intravenous ELIXCYTE was well tolerated in moderate-to-severe CKD patients and its preliminary efficacy warrants future studies.