Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease

NCT06969807 | Recruiting Phase 2

• 2 other identifiers: S2025-166S2025-166-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients.

Conditions

Diabetic Kidney Disease (DKD)

Keywords

mesenchymal stromal cells(MSCs); Diabetic kidney disease (DKD)

Outcome Measures

Primary Outcomes (2)

• Urine protein

  Urine protein will be measured on 24h urine samples

  Change from baseline at 24 weeks

• estimated Glomerular Filtration Rate(eGFR)

  GFR will be estimated by CKD-EPI

  Change from baseline at 24 weeks

Secondary Outcomes (12)

• fasting blood glucose

  Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion

• HbA1c

  Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion

• Urinary Albumin/Creatinine Ratio(UACR)

  Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion

• proportion of outcome ( ≥50% declined in eGFR，reached end stage renal disease (ESRD), or occured Renal replacement)

  proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion

• proportion of major adverse cardiac events(MACE) and all-cause mortality

  proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion

Study Arms (1)

Amimestrocel

EXPERIMENTAL

patients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 14, 28, and week 8, 12, 16, 20, 24.

Drug: Amimestrocel

Interventions

Amimestrocel DRUG

In the first month (day 1, 14, 28): 1×10E6 cells per kilogram. From the 8th to the 24th week (week 8, 12, 16, 20, 24): 1.5×10E6 cells per kilogram.

Amimestrocel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women who are ≥18 and ≤ 80 years old.
• Diagnosed with type 2 diabetes mellitus.
• Diagnosed with diabetic kidney disease based on renal pathology within the past 10 years.
• The 24-hour urine protein quantification is continuously ≥ 3.5 g, or the urine albumin-to-creatinine ratio (UACR) \> 1000 mg/g.
• The estimated glomerular filtration rate (eGFR) ≥ 15 ml/min/1.73m² (calculated according to the CKD-EPI formula).
• The blood pressure can be controlled at BP ≤ 160/100 mmHg.
• Glycated hemoglobin (HbA1c) \< 9%.
• Willing and able to provide written informed consent.

You may not qualify if:

• Patients with kidney diseases not caused by diabetes mellitus.
• 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.
• Severe cardiovascular diseases, such as congenital heart diseases, atrial fibrillation, NYHA class Ⅲ-IV, unstable angina pectoris, etc.
• 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).
• Patients with severe hyperlipidemia: (serum triglyceride ≥ 6.2 mmol/L, serum low-density lipoprotein cholesterol ≥ 4.1 mmol/L).
• Hyperkalemia that cannot be controlled through diet or potassium-lowering treatment.
• 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.
• Patients with a history of malignant tumors within the past five years.
• Patients with a known history of severe allergy to component blood or blood products, or patients with a history of allergy to heterologous proteins.
• 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.
• Active infection within one week before enrollment and requiring treatment with intravenous antibiotics.
• Patients who have participated in other interventional clinical trials within three months before enrollment.
• The research physician deems that the patient's condition is not suitable for participating in this clinical study.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (6)

Beijing Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Capital Medical University Affiliated Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University

Beijing, Beijing Municipality, 102218, China

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

xiangmei chen

CONTACT

+86 010 66935462; liping.8@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 14, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2028
• Last Updated: March 27, 2026

Record last verified: 2025-09

Locations

CN (6)