Kidney repair cells tested in diabetes patients for first time
NCT ID NCT07275788
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new treatment called REGEND003, made from human kidney progenitor cells, in 15 people with type 2 diabetes and chronic kidney disease. The main goal is to check if the treatment is safe and tolerable. Participants will receive either the cell therapy or a placebo via injection into the kidney, and researchers will monitor for side effects and signs of inflammation or kidney function change.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- REGEND003 (human kidney progenitor cells)
- What this could lead to
- If safe and effective, this could point toward a new way to repair kidney damage in people with diabetes and chronic kidney disease.
- What could go wrong
- This is a very early, small phase 1 trial focused on safety, not effectiveness. The cells may not work as hoped, and there are risks from the injection procedure and the cells themselves.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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30 to 75 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.
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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: * Male or female, aged 30 to 75 years at the time of signing the informed consent form; * Diagnosed with Type 2 Diabetes Mellitus for at least 1 year; * Diagnosed with Chronic Kidney Disease (CKD); * Voluntarily sign the informed consent form, be able to cooperate in completing study-related procedures and examinations, capable of adequately recording or describing changes in their condition, and demonstrate strong compliance. Exclusion Criteria: * Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant); * At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test. Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well. * Presence of a current or prior history of malignant tumor at screening (with the exception of those with disease-free survival for more than 2 years, or malignancies deemed to be of low aggressiveness as assessed by the investigator). * Patients with Type 1 Diabetes Mellitus; * Patients undergoing regular hemodialysis or peritoneal dialysis; * Presence of severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening; * Presence of more than one episode of hypoglycemic coma (blood glucose ≤3.9 mmol/L) within 1 month prior to screening; * Patients intolerant to renal puncture/intrarenal injection procedures; * Patients with diagnosis of acute kidney injury, congenital or hereditary kidney diseases, renal atrophy, or other renal conditions deemed ineligible by the investigator, as well as patients with a history of kidney transplantation at screening; * Presence of severe systemic diseases within 6 months prior to screening and judged by the investigator as unsuitable for the study; * Patients requiring long-term anticoagulant or antiplatelet therapy who, in the investigator's judgment, cannot discontinue medication 1 week prior to renal puncture/intrarenal injection procedures; * Patients with suicidal risk, history of psychiatric disorders, or history of epilepsy at screening; * Patients with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening; * Patients participated in other clinical trials with interventions within 1 month prior to screening; * Subject with assessed survival time of less than 1 year by investigators at screening; * Investigators, co-investigators, study coordinators, employees of participating investigators or research centers, or family members of the above individuals; * Any condition that, in the investigator's judgment, may increase subject risk or interfere with the 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shanghai Tongji Hospital
RECRUITINGShanghai, 200000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A blood test at 50 could flag your risk of five diseases. can an app stop them?
- Two drugs, one goal: can finerenone or semaglutide cut kidney damage markers?