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Stem cell injection aims to repair kidneys in diabetes patients

NCT ID NCT07396155

Disease control Sponsor: PT. Prodia Stem Cell Indonesia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a one-time injection of stem cells from donated umbilical cords into the kidneys of 10 adults with diabetic kidney disease. The goal is to see if the treatment is safe and whether it can improve kidney function and reduce inflammation over 12 months. All participants receive the stem cells, and their results are compared to their own starting measurements.

What this could mean

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

Active substance
umbilical cord stem cells
What this could lead to
If this works, it could point toward a new way to slow or improve kidney damage in people with diabetes.
What could go wrong
This is a very small, early-phase trial with only 10 people and no comparison group. It's too soon to know if the stem cells actually help, and there may be unknown side effects.

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

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

30 to 65 years

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: * Diagnosed with Type 2 Diabetes Mellitus (T2DM) * Aged between 40 and 65 years * Diagnosed with chronic kidney disease (CKD) stage III or IV, defined as estimated GFR (eGFR) between 15-60 mL/min/1.73 m² (using CKD-EPI formula) * Renal biopsy showing diabetic nephropathy type IIa-IV * Presence of proteinuria, with urine albumin-to-creatinine ratio (UACR) between 30-3000 mg/g (spot morning urine sample) * Controlled diabetes, defined as HbA1c \<10.0% during screening * Blood pressure within the range of: Systolic 100-160 mmHg, Diastolic 60-100 mmHg * On stable standard therapy for diabetic nephropathy (e.g. ACE inhibitors or ARBs) for at least 12 weeks prior to screening * Willing to provide written informed consent and comply with all study procedures until completion Exclusion Criteria: * Active malignancy or history of cancer * Active liver disease or abnormal liver function (ALT or AST ≥2× upper limit of normal) * Hemoglobin \<8 g/dL or platelet count \<100,000/µL * Serious or unstable cerebrovascular or cardiovascular conditions within the last 6 months * Positive pregnancy test or currently breastfeeding (for women of reproductive age) * Currently receiving immunosuppressive therapy equivalent to ≥20 mg/day prednisone * History of participation in other stem cell research or therapy studies

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Conditions

The condition(s) this trial relates to.

diabetic kidney disease kidney disorder

As listed by the trial registrant

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

Diabetic nephropathy type 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dr. Sardjito General Hospital

    RECRUITING

    Yogyakarta, 55284, Indonesia

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