Table 1.

Standard Protocol Items: Recommendations for Interventional Trials diagram

		Month –0*	Month 0	Month 1	Month 2	Month 3	Month 4	Month 6	Month 9	Month 15
Enrollment	Patient screening	√
	Patient informed consent	√
	Patient randomization		√
Intervention	hUC-MSC (arm A)		√	√	√	√
	Normal saline (arm B)		√	√	√	√
	Primary endpoint		√	√	√	√	√	√	√	√
Assessment	Secondary endpoints		√	√	√	√	√	√	√	√
	Safety indicators		√	√	√	√	√	√	√	√
	Other recordings		√	√	√	√	√	√	√	√

*The screening visit. hUC-MSC: Human umbilical cord mesenchymal stem cell.