This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Amimestrocel will be administered at a target dose of 1×10\^6 MSCs/kg body weight on day 1, 4, 8, 15.
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
serum creatinine
Time frame: Change from baseline at 28 days
serum creatinine
Time frame: Change from baseline at 8,15,21 days, and 2, 3 months.
Stage of AKI
Evaluate the staging of Acute Kidney Injury (AKI) according to KDIGO guidelines.
Time frame: Change from baseline at 8, 15, 21, 28 days, and 2, 3 months.
proportion of study participants with Renal Replacement Therapy(RRT)
Time frame: proportion of study participants with RRT at 4, 8, 12 weeks and 12, 24 months
APACHE II or APACHE III
Time frame: Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months
SOFA
Sequential Organ Failure Assessment Score
Time frame: Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months
all-cause mortality ratio
Time frame: All-cause mortality ratio at 28 days
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 ) and urine tests(mRNA, miRNA, etc)
Time frame: Change from baseline at 8, 15, 28 days, 3 months.
Adverse Event and Serious Adverse Event
Time frame: Within 12 weeks after received Amimestrocel
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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_RECRUITINGsecondary malignant disease
Number of Participants with secondary malignant disease
Time frame: Within 24 months after received Amimestrocel