Safety and Tolerance of Donor-Derived Mesenchymal Stem Cells in Pediatric Living-Donor Liver Transplantation: The MYSTEP1 Study

Table 1

Assessment schedule MYSTEP1 study.

Visit

BL

MSC1

MSC2

Follow-up visits

Days after LT

−28

0

2 ± 1

4

7

10

28

90

180

270

360

540

720

Informed consent; Inclusion and exclusion criteria

x

Concomitant medication

x

x

x

x

x

x

x

x

x

x

x

TAC dosage

x

x

x

x

x

x

x

x

x

x

x

Anthropometric parameters

x

x

x

x

x

x

x

x

x

Vital signs

x

x

x

x

x

x

x

x

x

x

x

x

x

Physical examination

x

x

x

x

x

x

x

x

x

x

x

x

x

Tacrolimus blood trough level

x

x

x

x

x

x

x

x

x

x

x

Routine laboratory including liver parameters

x

x

x

x

x

x

x

x

x

x

x

x

x

eGFR

x

x

x

x

x

x

x

x

x

Virus PCR: EBV, HCMV, and ADV

x

x

x

x

x

x

x

x

x

HHV-6

x

x

x

Doppler ultrasonography

x

x

x

x

x

x

x

x

x

x

x

x

x

Infusional toxicity score

x

x

x

x

x

x

TNF-α and IL-6 serum levels

x

x

x

x

Immune monitoring

x

x

x

x

x

x

Antibodies: DSA; ANA, SMA, and LKMA

x

x

x

x

Percutaneous liver biopsy

x

MSC administration

x

x

BL: baseline; MSC1: first intraoperative MSC infusion; MSC2: second MSC infusion on postoperative day 2.