MedTrace Logo

Autologous Dendritic Cell as Adjunct Therapy for Diabetic Kidney Disease

NCT06866158 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

    collaborator OTHER

  • Universitas Prima Indonesia

    collaborator UNKNOWN

  • Universitas Pertahanan Indonesia

    collaborator UNKNOWN

  • PT. JES Kasih Nusantara Sejahterah

    lead INDUSTRY

Principal Investigators

  • dr Jonny, Sp.PD-KGH, M.Kes, M.M, DCN · Gatot Soebroto Central Army Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-08-05
Completion
2026-08-05

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06866158 on ClinicalTrials.gov