Table 2.
Phase | Details | Properties and Median Dose of MSCs | Nr. of Patients | Disease Context | Key Findings | Publication/Status | ClinicalTrials.gov Identifier | Year | |
---|---|---|---|---|---|---|---|---|---|
allo-MSCs | |||||||||
A | I | Allogeneic MSCs co-transplanted with haplo-HSCT and subsequent DLI | Allogeneic BM-MSCs, 0.75 × 106 MSC/kg | n = 5 (all received MSCs, no control) | NB (relapsed/refractory) | 2 of 5 patients achieved long-lasting remission (40 and 42 months) | Toporski et al. [82] | NCT00790413 | 2008 |
Neutrophil recovery in all children (median 13 days), platelet recovery in 4/5 children (12 days) | |||||||||
Rapid immune reconstitution of NK- and T cells | |||||||||
No primary aGVHD, but 4/4 patients had secondary GvHD after DLI | |||||||||
B | I | Allogeneic MSCs co-transplanted with haplo-HSCT and DLI | Allogeneic MSCs, no details or dose mentioned | MSC(+): n = 9, MSC(-): n = 17 | NB (relapsed/refractory) | Primary engraftment in 96% (25/26) of the patients | Illhardt et al. [83] | NCT00790413 | 2018 |
GvHD: no significant differences between MSC and non-MSC group |
DLI–donor lymphocyte infusion, haplo-HSCT–haploidentical HSCT, aGvHD–acute graft-versus-host disease.