Autologous Dendritic Cell as Adjunct Therapy for Diabetic Kidney Disease

NCT06866158 | Active Not Recruiting Phase 1

• 1 other identifier: CL-DKD-P01-ID
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Dendritic Cell; Immunotherapy; Diabetic Kidney Disease; Cellular Therapy; Autologous

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Change in Estimated Glomerular Filtration Rate

  From baseline to 4 weeks after treament

• Change in Angiogenesis Biomarker

  From baseline to 4 weeks after treament

• Change in Interleukin-6

  From baseline to 4 weeks after treament

• Change in tumor necrosis factor-α

  From baseline to 4 weeks after treament

• Change in interleukin-10

  From baseline to 4 weeks after treament

Other Outcomes (4)

• Change in Nerve Conduction Velocity

  From baseline to 4 weeks after treament

• Change in Toronto Clinical Neuropathy Score

  From baseline to 4 weeks after treament

• Knee X-ray

  Baseline and 4 weeks after intervention

Study Arms (1)

Autologous DCL

EXPERIMENTAL

Biological: Dendritic cell immunotherapy

Interventions

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.

Also known as: Immunotherapy Nusantara

Autologous DCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Prima Indonesia: collaborator
• Universitas Pertahanan Indonesia: collaborator
• PT. JES Kasih Nusantara Sejahterah: lead
• Rumah Sakit Pusat Angkatan Darat Gatot Soebroto: collaborator

Study Sites (1)

Gatot Soebroto Central Army Hospital

Jakarta Pusat, DKI Jakarta - Jakarta, 10410, Indonesia

Location

Related Publications (5)

• 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.

  PMID: 39340004 BACKGROUND

• 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.

  PMID: 39727989 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.

  PMID: 39727950 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.

  PMID: 39727944 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.

  PMID: 39852146 RESULT

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• dr Jonny, Sp.PD-KGH, M.Kes, M.M, DCN

  Gatot Soebroto Central Army Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All subjects that fulfilled the enrollment criteria were given a single dose of autologous DC therapy

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 10, 2025
• Study Start: May 1, 2024
• Primary Completion: August 5, 2024
• Study Completion (Estimated): August 5, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

ID (1)