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Could a One-Time injection of your own immune cells protect your kidneys?

NCT ID NCT06866158

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing whether a single injection of a person's own immune cells (dendritic cells and lymphocytes) can reduce kidney damage in type 2 diabetes. The cells are processed in a lab and then given back under the skin. Researchers will measure urine protein levels and kidney function over four weeks in 80 adults. The goal is to see if this approach can calm inflammation and protect the kidneys.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous dendritic cells and lymphocytes matured with SARS-CoV-2 S protein
What this could lead to
If it works, this could point toward a new way to slow or reverse kidney damage in people with type 2 diabetes, potentially reducing the need for dialysis or transplant.
What could go wrong
This is a very early (Phase 1/2), small, single-arm trial with no placebo group, so results may be due to chance or natural variation. The treatment uses a coronavirus protein to mature the cells, which is unusual and its safety and effectiveness are unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

80 people

The number who actually took part.

Started

May 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Gatot Soebroto Central Army Hospital

    Jakarta Pusat, DKI Jakarta - Jakarta, 10410, Indonesia

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Other studies related to the condition(s) this trial covers.