Table 4.
Kebriaei (2020) [37] | Kurtzberg (2020) [29] |
Kurtzberg (2020) [30] |
Murata (2021) [38] |
Ding (2023) [34] |
Donadel c (2023) |
|
---|---|---|---|---|---|---|
Type of study | phase 3 | phase 3 | expanded access | retrospective | retrospective | retrospective |
Participants | 163 | 54 | 241 | 309 | 54 | 52 |
Age a | 43.8 | 7.0 | 9.6 | 49 | 12.5 | 12.5 |
Severe aGVHD b (%) | 77.3 | 88.8 | 80.1 | 80.5 | 88.8 | 96.2 |
Source of MSC | BM | BM | BM | BM | UC | UC |
Lines of therapy | ≥3 | 2 | ≥2 | ≥1 | ≥3 | ≥3 |
No of infusions a | 8.8 | 9.9 | 11 | 8 | 2 | 4 |
Dose per infusion (×106/kg) | 2 | 2 | 2 | 2 | 2.54 | 4.73 |
Time to infusion (days) a | - | 12 | 23 | 29 | 19 | 36.5 |
OR day 28 (%) | 58.3 | 70.4 | 65.1 | 56 | 59.3 | 63.5 (71.5) d |
CR day 28 (%) | - | 29.6 | 14.1 | 24 | 44.4 | 36.6 (48.6) d |
OS day 100 (%) | - | 74.1 | 66.9 | - | - | 51.9 (62.9) d |
OS day 180 (%) | 34 | 68.5 | - | 40 | - | 38.5 (48.6) d |
aGVHD: acute graft-vs-host disease; MSC: mesenchymal stromal cell; OR: overall response; CR: complete response; OS: overall survival; BM: bone marrow; UC: umbilical cord; a Median or mean; b Grade III/IV or C/D; c present study; d (children).