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Can stem cells from urine help kidneys? small trial tests safety

NCT ID NCT06071143

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested whether stem cells taken from a patient's own urine (called KDSTEM Inj.) are safe for people with chronic kidney disease. Six participants received low or high doses of the cells through an IV. The main goal was to check for side effects, while also looking at kidney function changes. Because this is a very small, early trial, it cannot say if the treatment works, but it may guide future research.

What this could mean

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

Active substance
urine-derived stem cells (KDSTEM Inj.)
What this could lead to
If this works, it could point toward a new way to slow or manage chronic kidney disease using a patient's own stem cells.
What could go wrong
This is a very early, tiny Phase 1 safety study with only 6 people. It cannot prove effectiveness, and stem cell treatments carry unknown risks.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Feb 2024

Finished

Mar 2026

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

19 to 80 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: 1. Male or female aged between 19 and 80 at the time of signing the agreement 2. Chronic kidney disease patients with an eGFR of 20 to 59 ml/min/1.73m² by MDRD at the screening and baseline 3. Male or female of childbearing age agreed to use accurate birth control method during this clinical trial 4. Subjects voluntarily signed an agreement in writing for this clinical trial Exclusion Criteria: 1. Subjects who meet any of the following conditions at the screening visit 1. Systemic infection 2. HIV, HBV, HCV, Syphilis (+) 3. Blood pressure higher than 190mmHg of SBP or 110mmHg of DBP 4. AST or ALT higher than 3 times the upper limit of normal values 2. Subjects who received hemodialysis within 12 weeks prior to the screening or will be receive hemodialysis during this clinical trial 3. Subjects who received kidney transplantation or will be receive kidney transplantation during this clinical trial 4. Subjects diagnosed with the following diseases 1. Solid Tumors or Hematologic Malignancies within 5 years prior to the screening 2. Cognitive disorder, Alzheimer's disease or mental illness be clinically significant. 3. Alcohol or drug abuse 4. Severe Respiratory disease (Chronic Obstructive Pulmonary Disease, asthma, pneumonia, pulmonary embolism and pneumothorax, etc.) 5. Stroke 6. Heart related diseases (within 3 months prior to the screening severe cardiovascular conditions (angina Pectoris, myocardial infarction, unstable arrhythmia, heart failure, etc.) 5. Subjects who received cell therapy or another clinical trial product/device within 4 weeks prior to the screening 6. Subjects who were hypersensitivity reaction pertaining to penicillin, streptomycin, and amphotericin B 7. Subjects, as determined by an investigator, receiving treatment anticipated to affect the results of the clinical trials 8. Subjects being pregnant, providing breast milk, resulted in positive pregnancy test at screening or planning for pregnancy during this clinical trial 9. etc. Subjects determined unsuitable for this clinical trial by the investigator

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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

  • Chungnam National University Hospital

    Daejeon, Chungcheongnam-do, South Korea

More trials for these conditions

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