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| Name | Class |
|---|---|
| Rumah Sakit Pusat Angkatan Darat Gatot Soebroto | OTHER |
| Universitas Prima Indonesia | UNKNOWN |
| Universitas Pertahanan Indonesia | UNKNOWN |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous DCL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urine Albumin-Creatinine Ratio (UACR) from Baseline | UACR were evaluated at a total 5 time points: baseline, week 1, 2, 3, and 4. | From baseline to 4 weeks after treament |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Estimated Glomerular Filtration Rate | Estimated glomerular filtration rate (eGFR) calculated from serum creatinine using the CKD-EPI equation. | From baseline to 4 weeks after treament |
| Change in Angiogenesis Biomarker |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nerve Conduction Velocity | 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. | From baseline to 4 weeks after treament |
| Change in Toronto Clinical Neuropathy Score |
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:
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:
Unwilling to sign the written informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| dr Jonny, Sp.PD-KGH, M.Kes, M.M, DCN | Gatot Soebroto Central Army Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gatot Soebroto Central Army Hospital | Jakarta Pusat | DKI Jakarta - Jakarta | 10410 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39340004 | Background | Jonny J, Sitepu EC, Lister INE, Chiuman L, Putranto TA. The Potential of Anti-Inflammatory DC Immunotherapy in Improving Proteinuria in Type 2 Diabetes Mellitus. Vaccines (Basel). 2024 Aug 27;12(9):972. doi: 10.3390/vaccines12090972. | |
| 39727989 | Result | Setiawan E, Ginting CN, Jonny J, Hernowo BA, Putranto TA. Clinical Trial: Effect of Autologous Dendritic Cell Administration on Improving Neuropathy Symptoms and Inflammatory Biomarkers in Diabetic Neuropathy. Curr Issues Mol Biol. 2024 Dec 20;46(12):14366-14380. doi: 10.3390/cimb46120861. |
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Only individual participant data (IPD) underlying the results presented in the publication will be shared.
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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All subjects that fulfilled the enrollment criteria were given a single dose of autologous DC therapy
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|
An angiogenesis biomarker, vascular endothelial growth factor (VEGF) were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.
| From baseline to 4 weeks after treament |
| Change in Interleukin-6 | Interleukin-6 (IL-6), an inflammatory biomarker, was evaluated at both baseline and 4 weeks post-treatment. With measurements expressed in pg/mL. | From baseline to 4 weeks after treament |
| Change in tumor necrosis factor-α | 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. | From baseline to 4 weeks after treament |
| Change in interleukin-10 | Interleukin-10 (IL-10), an inflammatory biomarker, was evaluated at both baseline and 4 weeks post-treatment. With measurements expressed in pg/mL. | From baseline to 4 weeks after treament |
| Change in transforming growth factor-β | Transforming growth factor-β (TGF-β), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in pg/mL. | From baseline to 4 weeks after treament |
| Change in matrix metalloproteinase-9 | 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. | From baseline to 4 weeks after treament |
| Change in endhotelin | Endhotelin, an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in pg/mL. | From baseline to 4 weeks after treament |
| Change in intercellular adhesion molecule | Change in intercellular adhesion molecule (ICAM), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in ng/mL. | From baseline to 4 weeks after treament |
| Change in vascular cell adhesion protein | 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. | From baseline to 4 weeks after treament |
| Change in kidney perfusion | Doppler Ultrasonography (Doppler USG) of the kidneys were performed at baseline and 4 weeks post-treatment. | From baseline to 4 weeks after treament |
| Change in kidney tissue and function | Magnetic Resonance Imaging Diffusion Weighted Imaging (MRI DWI) of the kidneys were performed at baseline and 4 weeks post-treatment. | From baseline to 4 weeks after treament |
| Change in kidney tissue and function | Magnetic Resonance Imaging Diffusion Tensor Imaging (MRI DTI) of the kidneys were performed at baseline and 4 weeks post-treatment. | 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. |
| From baseline to 4 weeks after treament |
| Knee X-ray | Knee X-ray done on both knee and graded using Kellgren-Lawrence grading system | Baseline and 4 weeks after intervention |
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 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. | Baseline to 4 weeks after intervention |
| 39727950 | Result | Dimu PS, Icksan AG, Farhat, Jonny, Hernowo BA, Putranto TA. Clinical Trial of Autologous Dendritic Cell Administration Effect on Water Molecule Diffusion and Anti-Inflammatory Biomarkers in Diabetic Kidney Disease. Curr Issues Mol Biol. 2024 Dec 4;46(12):13767-13779. doi: 10.3390/cimb46120822. |
| 39727944 | Result | Jonny, Sitepu EC, Hernowo BA, Chiuman L, Lister INE, Putranto TA. Open-Label Clinical Trial on the Impact of Autologous Dendritic Cell Therapy on Albuminuria and Inflammatory Biomarkers (Interleukin-6, Interleukin-10, Tumor Necrosis Factor alpha) in Diabetic Kidney Disease (DKD). Curr Issues Mol Biol. 2024 Dec 2;46(12):13662-13674. doi: 10.3390/cimb46120816. |
| 39852146 | Result | Yana ML, Sitepu EC, Jonny, Chiuman L, Lister INE, Putranto TA. The Effect of Autologous Dendritic Cell Immunotherapy on Kidney Function and Endothelial Dysfunction of Patients with Diabetic Kidney Disease (DKD): An Open Label Clinical Trial. Curr Issues Mol Biol. 2025 Jan 6;47(1):31. doi: 10.3390/cimb47010031. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |