Safety and tolerability of autologous bone marrow mesenchymal stromal cells in ADPKD patients

Table 1 Assessment schedule

	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

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
^aAE and SAE were assessed during the follow-up visit and when reported by patients

ISSN: 1757-6512