NCT06866158

Autologous Dendritic Cell as Adjunct Therapy for Diabetic Kidney Disease

Single-arm Open-label Clinical Trial: Autologous Dendritic Cells and Lymphocytes in Type 2 Diabetes Mellitus With Albuminuria

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: PT. JES Kasih Nusantara Sejahterah · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this single-arm, open-label clinical trial is to evaluate the effects of subcutaneous autologous dendritic cell (DC) and lymphocyte administration on albuminuria and endothelial dysfunction in Type 2 Diabetes Mellitus (T2DM) patients with Diabetic Kidney Disease (DKD). The main questions it aims to answer are: * Does autologous DC immunotherapy reduce urine albumin-creatinine ratio (UACR) in DKD patients? * What are the underlying mechanisms (modulation of inflammation, endothelial dysfunction, angiogenesis, fibrosis, and structural changes) through which DC immunotherapy reduces UACR in DKD patients? Participants will: * Undergo collection of autologous dendritic cells, which will be matured ex vivo using SARS-CoV-2 S protein. * Receive a single subcutaneous injection consisting of matured dendritic cells and lymphocyte reinfusion. * Have UACR measured at baseline and at weeks 1, 2, 3, and 4 post-immunotherapy. * Undergo assessments of other laboratory parameters and kidney imaging (ultrasonography and/or magnetic resonance imaging) at baseline and week 4 post-treatment. * What is the effect of autologous DC immunotherapy on knee OA, assessed by radiographic changes (x-ray) and patient-reported outcomes (WOMAC score)? Additionally, a subgroup of subjects who had neuropathy as comorbidity will be assessed using Electromyography (EMG) and the Toronto Clinical Neuropathy Scale (TCNS). These assessments aimed to determine the impact of the intervention on peripheral nerve function, clinical neuropathy symptoms over the study period. Another subgroup of subjects who had knee osteoarthritis will be assessed their knee x-ray and Western Ontario and McMaster Universities osteoarthritis index (WOMAC) score. These assessments aimed to determine the impact of the intervention on knee anatomic structure, function, and pain.

Conditions

• Diabetic Kidney Disease (DKD)

Interventions

Type	Name	Description
BIOLOGICAL	Dendritic cell immunotherapy	DCL (Dendritic Cells+Lymphocytes) previously matured with S-Protein of SARS-CoV-2. The number of cells given depends on individual yields.

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-08-05
• Completion: 2026-08-05
• First posted: 2025-03-10
• Last updated: 2025-12-05

Locations

1 site across 1 country: Indonesia