Autologous Dendritic Cell as Adjunct Therapy for Diabetic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-08-05

Brief Summary

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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:

* 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.

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Detailed Description

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Conditions

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Diabetic Kidney Disease (DKD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous DCL

Group Type EXPERIMENTAL

Dendritic cell immunotherapy

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Immunotherapy Nusantara

Eligibility Criteria

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Inclusion Criteria

1. Male or female over 18 years old
2. Understands and agrees to comply with study procedures by providing written informed consent.
3. In the investigator's judgment, the subject is able and willing to comply with study procedures.
4. 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
5. Meets the diagnostic criteria for Type 2 Diabetes Mellitus (DM) according to Indonesia's Endocrinology Society (PERKENI) 2021.
6. eGFR ≥ 30 mL/min/1.73 m².
7. Urinary albumin-creatinine ratio (UACR) ≥ 30 mg/g.

Exclusion Criteria

1. Receiving immunosuppressive treatments such as corticosteroids, hydroxychloroquine, methotrexate, cyclophosphamide, and others within the last 4 weeks.
2. Known to have other kidney diseases (e.g., polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, etc.).
3. Known to have other conditions that can cause albuminuria (e.g., myeloma, rhabdomyolysis, paroxysmal nocturnal hemoglobinuria, orthostatic albuminuria, etc.).
4. Diagnosed with other types of diabetes (Type 1 DM, gestational DM, or other forms of DM).
5. Positive pregnancy test.
6. Known to have immunodeficiency diseases such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV); no blood testing required.
7. Requires oxygen supplementation.
8. Diagnosed with invasive cancer and currently receiving anti-cancer therapy, except for hormonal therapy for breast or prostate cancer.
9. History of thromboembolism or a genetic predisposition to thromboembolism, or currently on anti-thromboembolic therapy other than low-dose aspirin.
10. Physical or mental disabilities preventing normal daily activities.
11. 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.
12. Measurable parameters include:

* Severe obesity: BMI \> 40
* Uncontrolled hypertension: systolic \>180 mmHg, diastolic \>100 mmHg
13. Unwilling to sign the written informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No