Real-World Data as External Control in Assessing the Efficacy of Allogeneic Adipose-Derived Stem Cells Therapy for Advanced Chronic Kidney Disease.

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Chronic kidney disease is a progressive condition with limited therapeutic options in its advanced stages. Adipose-derived stem cell therapy has shown potential in preclinical studies for renal repair. This study evaluated the short-term stability of renal function in patients with moderate to severe chronic kidney disease who received adipose-derived stem cell therapy, using a matched control group derived from real-world clinical data for comparison. A total of 34 treated patients were matched in a one-to-five ratio with 170 control patients based on key clinical characteristics. The primary outcomes included the mean percentage change in estimated glomerular filtration rate and the incidence of renal function decline exceeding defined thresholds. To enhance the robustness of treatment effect estimation, real-world data were utilized to construct an external control group that closely resembled the clinical trial population. This approach allowed indirect treatment comparisons and strengthened the internal validity of findings in the absence of randomization. Results demonstrated that the treated group exhibited a more stable renal function trajectory and a significantly lower risk of deterioration compared to the control group, particularly in patients with more advanced disease. Among dose groups, the low-dose group showed the greatest stability in renal function. These fin

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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