Can donor stem cells be safely infused into failing kidneys?
NCT ID NCT05042206
First seen Sep 25, 2026 · Last updated Sep 25, 2026
Summary
Researchers are testing whether repeated infusions of donor bone marrow stem cells are safe for people with stage 3b or 4 chronic kidney disease. Ten participants will receive three intravenous doses of the cells, each two weeks apart. The study tracks medical problems for a year after the last infusion and also measures changes in kidney function markers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- allogeneic bone marrow-derived mesenchymal stem cells
- What this could lead to
- If the infusions prove safe, researchers could study whether these cells help preserve kidney function in people with chronic kidney disease.
- What could go wrong
- This is a small, early-stage safety study with 10 participants, so it cannot show whether the treatment works. The infusions may cause side effects, and any kidney benefit seen in a few people might not hold up in larger trials.
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
-
10 people
The number who actually took part.
- Started
-
Nov 2021
- Finished
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Sep 2023
- 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 79 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Male or female participants aged 19 to less than 80 years. * Participants diagnosed with Stage 3b or Stage 4 chronic kidney disease (CKD) \[eGFR 15-44 mL/min/1.73 m²\] within 1 year prior to screening. * Participants who voluntarily agree to participate in the clinical trial and provide written informed consent. Exclusion Criteria: * Those with severe cardiovascular disease (angina, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit * Those with the following medical history/comorbidities A. Gentamicin hypersensitivity reaction B. Solid cancer or malignant blood disease within 5 years prior to screening C. Clinically significant cognitive disorder, dementia or psychiatric disorder D. Alcohol or drug abuse E. Severe respiratory disease (COPD, asthma, pneumonia, pulmonary embolism, pneumothorax, etc.) F. Stroke G. Systemic autoimmune disease * Those whose test results fall under the following at the screening visit A. Pathogenic microorganism test (Hbs Ag, HCV Ab, HIV Ab, Syphilis) positive B. Uncontrolled hypertension (systolic blood pressure \>190 mmHg or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg or diastolic blood pressure \<50 mmHg) C. AST and ALT ≥ upper limit of normal x 3.0 D. Total bilirubin ≥ upper limit of normal x 1.5 * At screening, those who have the following treatment history A. Those who are being treated for severe systemic infection B. Those who have been treated with immunosuppressant within 28 days prior to screening * Those with a history of renal transplantation * Those who have received dialysis within 3 months prior to the screening visit or who are planning to undergo dialysis during the clinical trial period * Pregnant, lactating, or planning during clinical trials * Those who do not agree to comply with the contraceptive method specified in this protocol during the clinical trial period * Those who are receiving drugs that are expected to affect the results of this clinical trial when judged by the investigator * Those who participated in other interventional clinical trials within 4 weeks prior to the screening visit and received investigational products/medical devices for investigational use or received procedures * Those who have or are planning to administer other cell therapy products * Those who are judged by the investigator to be inappropriate to participate in this clinical trial
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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
-
Asan Medical Center
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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