Prospective Double-Blind Randomized Study of Single Dose Bone Marrow-Derived Mesenchymal Stromal Cells versus Placebo for Steroid-Refractory Acute Graft-Versus-Host Disease
Bibliographic record
Abstract
Background: Mesenchymal stromal/stem cells (MSCs) may be a useful therapy for severe acute graft-versus-host disease (GVHD). Methods: Patients who developed steroid-refractory grade II-IV acute GVHD were randomly assigned to treatment with one infusion of third-party 2 × 10 E6/kg bone marrow (BM)-MSCs (n = 12) or placebo (n = 11). The median cell dose applied was 2.2 × 10 E6/kg (range 1.7–4.2). The median age was 37 and 47 years in the two groups (p = 0.24), respectively. Results: At day 28, the BM-MSC group had six (50%) complete responders and 2 patients (17%) with a partial response. In the placebo group, the corresponding figures were three (27%) complete and three (27%) partial responders (p = 0.68). Transplantation-related mortality (TRM) 100 days after treatment was 17% in the BM-MSC group and 27% in the placebo group. At 1 year, TRM was 33% and 36% in the two groups, respectively (p = 0.59). The 100-day survival rate was 83% in the BM-MSC group and 73% in the placebo group. Five-year survival in all patients was 42% and 45% in the two groups, respectively (p = 0.87). Conclusion: Although only a few patients were included in the trial, a single dose of BM-MSCs did not seem to be an effective therapy for steroid-refractory acute GVHD.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".