Open-Label Clinical Trial on the Impact of Autologous Dendritic Cell Therapy on Albuminuria and Inflammatory Biomarkers (Interleukin-6, Interleukin-10, Tumor Necrosis Factor α) in Diabetic Kidney Disease (DKD)

The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide, leading to a higher incidence of diabetic kidney disease (DKD), a major risk factor for end-stage kidney disease (ESKD). This study investigates the effects of autologous dendritic cell (DC) therapy on albuminuria and inflammatory biomarkers (IL-6, IL-10, and TNF-α) in DKD patients. An open-label clinical trial was conducted with 69 DKD outpatients at the Gatot Soebroto Army Central Hospital (RSPAD GS). Each subject received a single DC injection, with evaluations of urinary albumin-creatinine ratio (UACR) and inflammatory biomarkers at baseline and 4 weeks post-intervention. UACR was measured weekly, while eGFR, IL-6, IL-10, and TNF-α levels were assessed at baseline and week 4. Results indicated a significant reduction in median UACR from 250 mg/g at baseline to 153 mg/g in week 1, with sustained lower levels over 4 weeks (p < 0.05). No significant change of eGFR was found (p = 0.478). TNF-α levels also significantly decreased from 2.16 pg/mL to 1.92 pg/mL (p = 0.03), while IL-6 (p = 0.83) and IL-10 (p = 0.11) showed no significant change. The reduction in UACR and TNF-α suggests that DC therapy may alleviate albuminuria through anti-inflammatory mechanisms primarily suppressing TNF-α. No significant change in IL-10 levels implies that the anti-inflammatory effect is not mediated by IL-10 enhancement. This study demonstrates the potential of DC therapy as adjunct therapy to reduce albuminuria in DKD patients, with further research needed to explore long-term efficacy, long-term safety, and dosing strategies.