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Table 1 Assessment schedule

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
  1. SV screen visit, BV1 baseline visit before bone marrow aspiration (BMA), BV2 baseline visit before infusion day, V visit, d day, CBC complete blood count, BUN blood urea nitrogen, eGFR estimated glomerular filtration rate, TG triglycerides, Chol cholesterol, LDL low-density lipoprotein, HDL high-density lipoprotein, FBS fasting blood sugar, HbA1c hemoglobin A1c, TSH thyroid-stimulating hormone, PTH parathyroid hormone, ESR erythrocyte sedimentation rate, CRP C-reactive protein, ALT alanine aminotransferase, AlK-p alkaline phosphatase, AST aspartate aminotransferase, HIV human immunodeficiency virus, HCV hepatitis C virus, HBV hepatitis B virus, HTLV human T-lymphotropic virus, DTPA diethylenetriaminepentaacetic acid, BM bone marrow, MSC mesenchymal stromal cell, AE adverse event, SAE serious adverse event
  2. aAE and SAE were assessed during the follow-up visit and when reported by patients