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Tests treatment safety and results for Diabetic Kidney Disease (DKD)
Official title Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease
ClinicalTrials.gov ID: NCT06969807
What this study is testing
What is Amimestrocel?
Amimestrocel is an investigational medicine, being studied as a potential treatment for diabetic kidney disease (dkd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 1. 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).
You likely can't join 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...
- 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...
- 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.
See the full eligibility criteria
- 1. 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.
- 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...
- 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...
- 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...
- Active infection within one week before enrollment and requiring treatment with intravenous antibiotics.
- Patients who have participated in other treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.