Table 1.
Demographics of acute graph-versus-host disease patients receiving mesenchymal stromal cell therapy
| Characteristic | Responders | Non-responders | P value |
|---|---|---|---|
| Total number of patients | 8 | 8 | |
| Age at HSCT (years): median (min–max) | 58.4 (34.0–64.9) | 54.3 (13.5–65.8) | 0.96a |
| Female sex: N (%) | 4 (50) | 2 (25) | 0.61b |
| Underlying disease: N (%) | |||
| Myeloid neoplasm | 4 (50) | 7 (87.5) | 0.35b |
| Lymphoid neoplasm | 2 (25) | 1 (12.5) | |
| Plasma cell dyscrasia | 1 (12.5) | 0 (0) | |
| Prostate cancer | 1 (12.5) | 0 (0) | |
| Donor: N (%) | |||
| HLA-identical sibling | 5 (62.5) | 5 (62.5) | 1b |
| Matched unrelated donor | 3 (37.5) | 3 (37.5) | |
| Conditioning: N (%) | |||
| Standard | 5 (62.5) | 6 (75) | 1b |
| Reduced intensity (RIC) | 3 (37.5) | 2 (25) | |
| Timeline (days): median (min–max) | |||
| Time from HSCT or DLI to aGVHD | 32.5 (13–107) | 35.5 (11–169) | 0.96a |
| Time from aGVHD diagnosis to steroid treatment | 1.5 (0–7) | 1 (0–7) | 0.91a |
| Time from steroid treatment to MSC treatment | 8 (3–44) | 15 (4–55) | 0.17a |
| Time from steroid treatment to biopsy# | 2 (0–13) | 6 (1–29) | 0.18a |
| Biopsy before initiation of steroid treatment (N) | 1 | 0 | 1b |
| Time from biopsy to MSC treatment | 5.5 (2–37) | 9.5 (3–26) | 0.34a |
| aGVHD global clinical classification: N (%) | |||
| Grades 0–I | 0 (0) | 0 (0) | NA |
| Grade II | 0 (0) | 0 (0) | |
| Grades III–IV | 8 (100) | 8 (100) | |
| GI aGVHD pathological classification: N (%) | |||
| Grades 0–I | 0 (0) | 3 (37.5) | 0.077b |
| Grade II | 0 (0) | 1 (12.5) | |
| Grades III–IV | 8 (100) | 4 (50) | |
| CMV infection: N (%) | |||
| CMV colitis | 2 (25) | 3 (37.5) | 1b |
| CMV viremia (> 1000 copies/ml) | 2 (25) | 4 (50) | 0.61b |
| Leukocyte counts at time of biopsy: Mean (± SD) ¶ | |||
| Total leukocytes (× 109)/L) | 11.26 (± 1.86) | 9.86 (± 8.28) | 1a |
| Neutrophils (× 109/L) | 8.98 (± 1.81) | 7.79 (± 6.54) | 1a |
| Eosinophils (× 109/L) | 0.04 (± 0.07) | 0.05 (± 0.09) | 0.82a |
| Basophils (× 109/L) | 0.01 (± 0.01) | 0.05 (± 0.09) | 0.65a |
| Lymphocytes (× 109/L) | 0.90 (± 0.66) | 0.63 (± 0.49) | 0.60a |
| Monocytes (× 109/L) | 1.00 (± 0.70) | 1.19 (± 1.47) | 0.84a |
aWilcoxon rank-sum test
bFisher’s exact test
#Excluding patients that were biopsied before steroid treatment
¶Samples taken > 6 days from date of biopsy are excluded
GI gastro-intestinal, CMV cytomegalovirus, MSC mesenchymal stromal cell, aGVHD acute graft-versus-host disease, DLI donor lymphocyte infusion, HSCT hematopoietic stem cell transplantation, NA not available, aHSCT allogeneic hematopoietic stem cell transplantation, HLA human leukocyte antigen, RIC reduced intensity conditioning, DLI donor lymphocyte infusion, SEM standard error of the mean