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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
Beijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGCapital Medical University Affiliated Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Urine protein
Urine protein will be measured on 24h urine samples
Time frame: Change from baseline at 28 weeks
estimated Glomerular Filtration Rate(eGFR)
GFR will be estimated by CKD-EPI
Time frame: Change from baseline at 28 weeks
fasting blood glucose
fasting blood glucose
Time frame: Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion
HbA1c
Glycated Hemoglobin A1c
Time frame: Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Urinary Albumin/Creatinine Ratio(UACR)
UACR will be measured on spot morning urine samples
Time frame: Change from baseline at 28 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 outcome ( ≥50% declined in eGFR,reached End Stage Renal Disease (ESRD), or occured Renal Replacement Therapy)
Time frame: proportion of study participants within outcome at 28 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 major adverse cardiac events(MACE:CV death, non-fatal CV event(myocardial infarction, stroke, hospitalization for HF)) and all-cause mortality
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGChinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGTime frame: proportion of study participants within outcome at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Mechanism exploration
Explore the mechanism through blood tests(Serum/plasma concentrations (pg/ml) of biomarkers of inflammation. Proportion/total number of circulating T cells, B cells, NK cells, etc ).
Time frame: Change from baseline at 4,12,28 weeks and 12 months
changes in retinal imaging
Macular vascular density by Optical Coherence Tomography Angiography (OCTA), and analyze the percentage of changes in retinal imaging of patients compared to the baseline .
Time frame: Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Changes in peripheral nerve injury
Examine through electromyography, to evaluate the percentage of changes in peripheral nerve injury of patients compared with the baseline.
Time frame: Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Changes in symptoms
The traditional Chinese Medicine(TCM)Syndrome Rating Scale will be used to score TCM symptoms,to evaluate the percentage of changes in the symptoms of patients compared with the baseline.
Time frame: Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Changes in the quality of life scale
The Diabetes Quality-of-Life Measure (DQOL) will be used to score quality of life at each visit, to evaluate the percentage of the change in the DQOL of patients compared to the baseline
Time frame: Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Adverse Event and Serious Adverse Event(SAE)
Time frame: within 28 weeks after received Amimestrocel
secondary malignant disease
Number of Participants with secondary malignant disease
Time frame: within 24 months after received Amimestrocel