Could stem cells save kidneys in diabetes?
NCT ID NCT06969807
First seen Jun 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times
Summary
This study tests a stem cell treatment called Amimestrocel in 120 people with diabetic kidney disease. The cells are given through an IV multiple times over 6 months. Researchers will check if it lowers protein in urine and improves kidney function. The goal is to see if this approach can slow down kidney damage caused by diabetes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Amimestrocel (umbilical cord-derived mesenchymal stromal cells)
- What this could lead to
- If it works, this could point toward a new treatment to slow kidney damage and reduce protein leakage in people with diabetic kidney disease.
- What could go wrong
- This is an early Phase 2 trial with only 120 people, so results may not apply to everyone. The treatment involves multiple infusions and could have side effects like infusion reactions or infection.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 to 80 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: - 1. Men and women who are ≥18 and ≤ 80 years old. 2. Diagnosed with type 2 diabetes mellitus. 3. Diagnosed with diabetic kidney disease based on renal pathology within the past 10 years. 4. The 24-hour urine protein quantification is continuously ≥ 3.5 g, or the urine albumin-to-creatinine ratio (UACR) \> 1000 mg/g. 5. The estimated glomerular filtration rate (eGFR) ≥ 15 ml/min/1.73m² (calculated according to the CKD-EPI formula). 6. The blood pressure can be controlled at BP ≤ 160/100 mmHg. 7. Glycated hemoglobin (HbA1c) \< 9%. 8. Willing and able to provide written informed consent. Exclusion Criteria: 1. Patients with kidney diseases not caused by diabetes mellitus. 2. Patients who have received treatment with systemic immunosuppressants (such as cyclosporine A, tacrolimus, mycophenolate mofetil, etc.) within 30 days before enrollment and the duration of treatment exceeds one week. 3. Severe cardiovascular diseases, such as congenital heart diseases, atrial fibrillation, NYHA class Ⅲ-IV, unstable angina pectoris, etc. 4. A history of cerebral hemorrhage or cerebral infarction within the past six months (except for those with a history of lacunar cerebral infarction without residual limb movement disorders, cognitive and language function disorders). 5. Patients with severe hyperlipidemia: (serum triglyceride ≥ 6.2 mmol/L, serum low-density lipoprotein cholesterol ≥ 4.1 mmol/L). 6. Hyperkalemia that cannot be controlled through diet or potassium-lowering treatment. 7. Patients with active infections of hepatitis B or hepatitis C viruses (the copy number of HBV DNA or HCV RNA exceeds the upper limit of the normal value); patients with active tuberculosis; patients with severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc. 8. Patients with a history of malignant tumors within the past five years. 9. Patients with a known history of severe allergy to component blood or blood products, or patients with a history of allergy to heterologous proteins. 10. Lactating women, or female patients who have a pregnancy plan or an egg donation plan from the start of the study to the follow-up period, and male patients (or their partners) who have a childbearing plan or a sperm donation plan from the start of the study to the follow-up period and are unwilling to take contraceptive measures. 11. Active infection within one week before enrollment and requiring treatment with intravenous antibiotics. 12. Patients who have participated in other interventional clinical trials within three months before enrollment. 13. The research physician deems that the patient's condition is not suitable for participating in this clinical study.
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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
6 sites. 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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Beijing Hospital
RECRUITINGBeijing, Beijing Municipality, 100010, China
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Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 102218, China
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Capital Medical University Affiliated Beijing Friendship Hospital
RECRUITINGBeijing, Beijing Municipality, 100050, China
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China-Japan Friendship Hospital
RECRUITINGBeijing, Beijing Municipality, 100029, China
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Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
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Xuanwu Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100053, China
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- Can a strong support network help people with diabetic kidney disease take better care of themselves?
- New strategy aims to protect kidneys and hearts in diabetes patients
- New registry aims to uncover real-world diabetic kidney disease care in underserved groups
- New drug aims to shield kidneys and heart in diabetic patients
- Could a One-Time injection of your own immune cells protect your kidneys?