|  |  | Placebo | MSC | P value |
---|---|---|---|---|---|
Kaplan–Meier overall survival | 1 year | Rate | 80% | 74% | 0.64 |
5Â years | Rate | 58% | 44% | Â | |
Kaplan–Meier progression-free survival | 1 year | Rate | 80% | 65% | 0.41 |
5Â years | Rate | 42% | 33% | Â | |
Cumulative incidence of relapse | 1Â year | Rate | 21% | 23% | 0.59 |
5Â years | Rate | 32% | 41% | Â | |
Cause of death (hemopathy/GVHD/other) | Â | Number | 3/3/0 | 4/3/5 | 0.63 |
aGVHD | |||||
Grade 1/2/3/4 | Â | Number | 1/4/2/2 | 2/6/2/1 | 0.87 |
100-d cumulative incidence of aGVHR, grades II-IV | Â | Rate | 53% | 30% | 0.15 |
100-d cumulative incidence of aGVHR, grades III-IV | Â | Rate | 27% | 9% | 0.13 |
aGVHD resolution (CR/no CR) | Â | Number | 6/3 | 6/5 | 0.67 |
cGVHD | |||||
Mild/Moderate/Severe | Â | Number | 2/2/4 | 4/5/3 | 0.71 |
5-yr cumulative incidence of cGVHR, overall | Â | Rate | 67% | 48% | 0.27 |
5-yr cumulative incidence of cGVHR, moderate/severe | Â | Rate | 40% | 30% | 0.56 |
cGVHD resolution (CR/no CR) | Â | Number | 2/6 | 5/7 | 0.44 |
Donor engraftment (no/yes) | Â | Number | 0/15 | 0/23 | 1 |
Chimemism (full donor/other)* | Â | Number | 13/1 | 22/1 | 0.72 |
T lymphocyte count on day 30, median |  | /µL | 530 | 363 | 0.56 |
Neutrophil recovery (complete/partial) | Â | Number | 15/0 | 23/0 | 0.19 |
Median time to 1,000 PMN/µL |  | Days | 13 | 17 | 0.0174 |
Red blood cell recovery (complete/partial or none)* | Â | Number | 11/3 | 14/4 | 0.96 |
Median time to hemoglobin > 10 g/dl |  | Days | 59 | 73 | 0.94 |
Red blood cell transfusions days 0–30, median |  | Number | 1 | 1 | 0.57 |
Median time to RBC transfusion independence | Â | Days | 16 | 22 | 0.57 |
Platelet recovery (complete/partial or none) | Â | Number | 13/2 | 22/1 | 0.32 |
Median time to 50,000 platelets/µL |  | Days | 11 | 11 | 0.93 |
Median time to 100,000 platelets/µL |  | Days | 14 | 16 | 0.54 |
Platelet count on day 30, median |  | 103/µL | 100 | 134 | 0.14 |
Platelet transfusions days 0–30, median |  | Number | 0 | 0 | 0.31 |
Infections | |||||
Cumulative incidence of infection | Â | Rate | 80% | 91% | 0.29 |
Cumulative incidence of sepsis | Â | Rate | 33% | 44% | 0.37 |
Cumulative incidence of CMV infection | Â | Rate | 33% | 35% | 0.82 |
Cumulative incidence of other infections | Â | Rate | 80% | 87% | 0.59 |
Second cancer (no/yes) | Â | Number | 14/1 | 20/3 | 0.53 |