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Active, Not Recruiting

NCT Number: NCT06866158

Autologous Dendritic Cell as Adjunct Therapy for Diabetic Kidney Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Kidney Disease (DKD) Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gatot Soebroto Central Army Hospital

Jakarta Pusat, DKI Jakarta - Jakarta, 10410, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female over 18 years old
  • Understands and agrees to comply with study procedures by providing written informed consent.
  • In the investigator's judgment, the subject is able and willing to comply with study procedures.
  • In the investigator's judgment, the subject is in generally good physical and mental health. This includes the following factors:
  • Age > 65 years
  • Mild to moderate obesity (BMI 30 to 40)
  • Controlled hypertension with medication
  • Controlled hyperlipidemia with medication
  • Mild chronic lung disease
  • Previously diagnosed with cancer and in remission for at least 1 year
  • Meets the diagnostic criteria for Type 2 Diabetes Mellitus (DM) according to Indonesia's Endocrinology Society (PERKENI) 2021.
  • eGFR ≥ 30 mL/min/1.73 m².
  • Urinary albumin-creatinine ratio (UACR) ≥ 30 mg/g.

Exclusion criteria

  • Receiving immunosuppressive treatments such as corticosteroids, hydroxychloroquine, methotrexate, cyclophosphamide, and others within the last 4 weeks.
  • Known to have other kidney diseases (e.g., polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, etc.).
  • Known to have other conditions that can cause albuminuria (e.g., myeloma, rhabdomyolysis, paroxysmal nocturnal hemoglobinuria, orthostatic albuminuria, etc.).
  • Diagnosed with other types of diabetes (Type 1 DM, gestational DM, or other forms of DM).
  • Positive pregnancy test.
  • Known to have immunodeficiency diseases such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV); no blood testing required.
  • Requires oxygen supplementation.
  • Diagnosed with invasive cancer and currently receiving anti-cancer therapy, except for hormonal therapy for breast or prostate cancer.
  • History of thromboembolism or a genetic predisposition to thromboembolism, or currently on anti-thromboembolic therapy other than low-dose aspirin.
  • Physical or mental disabilities preventing normal daily activities.
  • In the investigator's judgment, any illness or medical condition that may hinder the subject's participation, including acute, subacute, intermittent, or chronic diseases that could place the subject at risk of injury, prevent compliance with the study protocol, or interfere with study assessments.
  • Measurable parameters include:
  • Severe obesity: BMI > 40
  • Uncontrolled hypertension: systolic >180 mmHg, diastolic >100 mmHg
  • Unwilling to sign the written informed consent.

Treatment and study plan

Dendritic cell immunotherapy

Biological

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

Other names: Immunotherapy Nusantara

Primary outcomes

  1. Change in Urine Albumin-Creatinine Ratio (UACR) from Baseline

    Time frame: From baseline to 4 weeks after treament

    UACR were evaluated at a total 5 time points: baseline, week 1, 2, 3, and 4.

Secondary outcomes

  1. Change in Estimated Glomerular Filtration Rate

    Time frame: From baseline to 4 weeks after treament

    Estimated glomerular filtration rate (eGFR) calculated from serum creatinine using the CKD-EPI equation.

  2. Change in Angiogenesis Biomarker

    Time frame: From baseline to 4 weeks after treament

    An angiogenesis biomarker, vascular endothelial growth factor (VEGF) were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

  3. Change in Interleukin-6

    Time frame: From baseline to 4 weeks after treament

    Interleukin-6 (IL-6), an inflammatory biomarker, was evaluated at both baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

  4. Change in tumor necrosis factor-α

    Time frame: From baseline to 4 weeks after treament

    Tumor necrosis factor-α (TNF-α), an inflammatory biomarker, was evaluated at both baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

  5. Change in interleukin-10

    Time frame: From baseline to 4 weeks after treament

    Interleukin-10 (IL-10), an inflammatory biomarker, was evaluated at both baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

  6. Change in transforming growth factor-β

    Time frame: From baseline to 4 weeks after treament

    Transforming growth factor-β (TGF-β), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

  7. Change in matrix metalloproteinase-9

    Time frame: From baseline to 4 weeks after treament

    Change in matrix metalloproteinase-9 (MMP-9), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in ng/mL.

  8. Change in endhotelin

    Time frame: From baseline to 4 weeks after treament

    Endhotelin, an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

  9. Change in intercellular adhesion molecule

    Time frame: From baseline to 4 weeks after treament

    Change in intercellular adhesion molecule (ICAM), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in ng/mL.

  10. Change in vascular cell adhesion protein

    Time frame: From baseline to 4 weeks after treament

    Change in vascular cell adhesion protein (VCAM), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in ng/mL.

  11. Change in kidney perfusion

    Time frame: From baseline to 4 weeks after treament

    Doppler Ultrasonography (Doppler USG) of the kidneys were performed at baseline and 4 weeks post-treatment.

  12. Change in kidney tissue and function

    Time frame: From baseline to 4 weeks after treament

    Magnetic Resonance Imaging Diffusion Weighted Imaging (MRI DWI) of the kidneys were performed at baseline and 4 weeks post-treatment.

  13. Change in kidney tissue and function

    Time frame: From baseline to 4 weeks after treament

    Magnetic Resonance Imaging Diffusion Tensor Imaging (MRI DTI) of the kidneys were performed at baseline and 4 weeks post-treatment.

Other outcomes

  1. Change in Nerve Conduction Velocity

    Time frame: From baseline to 4 weeks after treament

    Changes in Nerve Conduction Velocity (m/s) as measured by Electromyography were conducted only on a subgroup of patients who had Neuropathy as a comorbidity and were assessed at two time points: baseline and 4 weeks post-treatment.

  2. Change in Toronto Clinical Neuropathy Score

    Time frame: From baseline to 4 weeks after treament

    Changes in Toronto Clinical Neuropathy Score (TCNS) were conducted only on a subgroup of patients who had Neuropathy as a comorbidity and were assessed at two time points: baseline and 4 weeks post-treatment.This scale is used to assess the severity of diabetic peripheral neuropathy. The score ranges from 0 to 15, with higher scores indicating worse neuropathy. It evaluates various clinical signs, such as the presence of symptoms like pain, numbness, and weakness, along with physical examination findings like ankle reflexes and vibration sensation. A higher score suggests more severe neuropathy and a worse outcome for the patient.

  3. Knee X-ray

    Time frame: Baseline and 4 weeks after intervention

    Knee X-ray done on both knee and graded using Kellgren-Lawrence grading system

  4. The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: Baseline to 4 weeks after intervention

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire for assessing pain, stiffness, and physical function in individuals with osteoarthritis of the hip or knee. The WOMAC is a 24-item tool that includes 5 questions on pain, 2 on stiffness, and 17 on physical function, with higher scores indicating worse symptoms.

Sponsors and collaborators

Lead sponsor

PT. JES Kasih Nusantara Sejahterah

Industry

Collaborators

  • Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
  • Universitas Pertahanan Indonesia
  • Universitas Prima Indonesia

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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