From: Safety and tolerability of autologous bone marrow mesenchymal stromal cells in ADPKD patients
SV | BV1 | V1 | BV2 | V2 | V3 | V4 | V5 | V6 | V7 | |
---|---|---|---|---|---|---|---|---|---|---|
Day | -56 | -49 | -42 | 0 | 1 | 30 | 90 | 180 | 270 | 360 |
Time window | NA | ±3d | ±7d | ±1d | ±1d | ±7d | ±7d | ±7d | ±7d | ±7d |
Informed consent | x | |||||||||
Physical examination | x | x | x | x | x | x | x | x | ||
Vital signs | x | x | x | x | x | x | x | x | x | |
Medical history | x | |||||||||
Laboratory assessments | x | x | x | x | x | x | x | |||
CBC | x | x | x | x | x | x | ||||
BG | x | x | x | x | x | x | ||||
NA, K, Ca, P | x | x | x | x | x | x | ||||
BUN | x | x | x | x | x | x | ||||
Uric acid | x | x | x | x | x | x | ||||
Serum creatinine | x | x | x | x | x | x | x | |||
eGFR | x | x | x | x | x | x | x | |||
Albumin | x | x | x | |||||||
TG, Chol, LDL,HDL | x | x | x | x | x | x | ||||
FBS | x | x | x | x | x | x | x | |||
HbA1c | x | x | ||||||||
TSH, PTH | x | x | ||||||||
ESR, CRP | x | x | x | x | x | x | ||||
ALT, ALK-p, AST | x | x | x | x | x | x | ||||
Dipstick proteinuria | x | x | x | x | x | x | ||||
HIV 1,2, HCV, HBV, HTLV | x | |||||||||
Eligibility criteria assessment | x | x | ||||||||
Kidney sonography | x | x | ||||||||
Kidney DTPA scan | x | x | ||||||||
BM harvesting | x | |||||||||
MSC infusion | x | |||||||||
Follow-up visit | x | x | x | x | x | |||||
AE assessment a | x | x | x | x | x | x | ||||
SAE assessment a | x | x | x | x | x | x |