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. 2024 Sep 27;15:1436194. doi: 10.3389/fgene.2024.1436194

TABLE 1.

Study characteristics of the two clinical trials.

Characteristic Liège study a Neptune study Leiden b
Phase Phase I-II single center Phase Ib single center
EUDRA CT 2011-001822-81 2013-005407-14
ClinicalTrials.gov identifier NCT01429038 NCT02387151
Number of patients 10 10
Duration of the primary study 12 months 12 months
Population 18–75 years, fist KTx, PRA ≤50% 18–75 years old first KTx recipients, PRA ≤50%
Kidney donor Deceased (DBD or DCD) Living (related or unrelated)
Time of MSC infusion One infusion at day 3 ± 2 post-Tx Two infusions at weeks 25 and 26 post-Tx
Dosage of MSCs 1.5 × 106 to 3 × 106/kg bodyweight 1.5 × 106/kg bodyweight
Source of MSCs Bone marrow, third-party donors Bone marrow, third-party donors
Selection of the MSC donor No HLA selection Avoidance of repeated HLA-A, B, -DR, and -DQ antigen mismatches
Induction for MSCs Methylprednisolone at 2 mg/kg bodyweight and promethazine Not performed
Induction for KTx Anti-interleukin-2 receptor antibodies on day 0 and day 4 Alemtuzumab
Maintenance immunosuppression Tacrolimus, mycophenolate mofetil, and corticosteroids Prednisone, tacrolimus, and everolimus
Immunosuppression minimization Not applicable Reduction of tacrolimus to trough levels of 1.5–3 ng/mL after the second MSC infusion
Primary endpoint Adverse effects of MSC infusion as well as infectious and malignant complications at 1 year Biopsy-proven acute rejection or graft loss
a

Erpicum et al. Kidney Int. 2019 March; 95 (3):693-707.

b

Dreyer et al. Am J Transplant. 2020 October; 20 (10):2905-2915.

DBD, donor after brain death; DCD, donor after circulatory death; KTx, kidney transplantation; MSC, mesenchymal stromal cell; PRA, panel-reactive antibody.