. 2021 Sep 7;18:321–333. doi: 10.1016/j.reth.2021.08.005

Table 5.

Schedule of study activities.

	Admission/screening	14 days after injury (if applicable)	1 day before transplant	14–28 days after injury	Post-transplant (days)
					7	21	35	56	84	112	140	168	365
					±2	±7	±7	±7	±7	±7	±7	±7	±14
Sign ICD	×
Health information	×^a
Inclusion/exclusion	×	×	×
Enrollment			×
Screening laboratories	×
HLA/MLR test	×
Cellular transplantation				×
Immunosuppression ^b			×	×	×	×	×	×	×	×	×	×
Report AEs and SAEs			×	×	×	×	×	×	×	×	×	×	×
Neurological examinations^c^,^d	×	×			×	×	×	×	×	×	×	×	×
AIS ^d	×	×	×	×	×	×	×	×	×	×	×	×	×
Rehabilitation therapy ^e	×	×	×	×	×	×	×	×	×	×	×	×	×
General status/vital signs ^e	×	×	×	×	×	×	×	×	×	×	×	×	×
MRI	×^a					×			×^g			×^g	×^g
FDG-PET												×^g
X-rays	×^a
Blood exams	×^a		×	×	×	×	×	×	×	×	×	×
Urinary exams	×^a
Ultrasonography of leg vein ^f	×^a		×			×		×	×	×	×	×	×
Discharge information ^h												×

Abbreviations: ICD, informed consent document; HLA, human leukocyte antigen; MLR, mixed lymphocyte reaction; AE, adverse event; SAE, severe adverse event; AIS, American Spinal Cord Injury Association Impairment Scale; MRI, magnetic resonance imaging; FDG-PET, fluorodeoxyglucose(¹⁸F) positron emission tomography.

Items that can use the data taken before admission.

Immunosuppressants will be used every day from day −1 to day 280 after transplantation.

Including the International Standards for Neurological Classification of Spinal Cord Injury, modified Frankel classification, zone of partial preservation, Pain DETECT, Neuropathic Pain Symptom Inventory, Modified Ashworth scale, and Spinal Cord Independence Measure version III.

Neurological examinations should be performed and AIS should be checked once per month after day 56.

Rehabilitation therapy and monitoring of general status/vital signs will be performed every day during hospitalization.

Ultrasonography of a leg vein will be performed once per month after transplantation.

Items that can be assessed within 1 month from the scheduled time-point.

Patients can be discharged after day 168. If desired, patients can opt to remain in hospital until the end of the initial observation period.