Can stem cells from urine help kidneys? small trial tests safety
NCT ID NCT06071143
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
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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