Table 2

The schedule of the study

Timepoint	Study period
	Enrolment (days)		Follow-up (days)					Follow-up (weeks)									Close-out
	−28 to −1	−7 to −1	0	1	4	7	8	2	4	8	12	16	24	28	36	44	52
Enrolment
Informed consent	X
Registration		X
Medical or drug history	X
Height	X
Body weight		X
Interventions
AMSCs			X			X
Assessments
Physical examination	X		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Vital signs	X		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Serological and biochemical tests		X		X	X	X	X	X	X	X	X	X	X	X	X	X	X
Infectious disease inspection	X
Urinalysis		X		X	X	X	X	X	X	X	X	X	X	X	X	X	X
Urine hCG-β (if needed)		X							X		X		X		X		X
Inflammatory markers		X		X	X	X	X	X	X	X	X	X	X	X	X	X	X
12-lead ECG		X	X			X		X	X	X	X	X	X	X	X	X	X
Chest X-ray examination	X							X			X				X
CT	X												X				X
Total colonoscopy		X							X				X				X
CDAI		X					X	X	X	X	X	X	X	X	X	X	X
IBDQ		X							X				X				X
Adverse events			X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Diary	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X

AMSC, amnion-derived mesenchymal stem cell; CDAI, Crohn’s disease activity index; hCG, human chorionic gonadotropin; IBDQ, Inflammatory Bowel Disease Questionnaire.