Could stem cells save kidneys in diabetes?

NCT ID NCT06969807

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

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

18 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. 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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100010, China

  • Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 102218, China

  • Capital Medical University Affiliated Beijing Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100050, China

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

  • Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

  • Xuanwu Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

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