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.