P4590Intra-myocardial injection of mesenchymal stromal cells in severe ischemic heart failure: final follow-up of the randomized placebo-controlled MSC-HF trial
Bibliographic record
Abstract
Background: Regenerative treatment with mesenchymal stromal cells (MSCs) has been promising in patients with ischemic heart failure but needs confirmation in larger randomized trials. Purpose: We aimed to study effects of intra-myocardial autologous bone marrow-derived MSC treatment in patients with severe ischemic heart failure. Methods: The MSC-HF trial is a randomized, double-blind, placebo-controlled trial. Sixty no option patients with severe ischemic heart failure were randomized 2:1 to intra-myocardial injections of either MSCs (40) or placebo (20). Primary endpoint was reduction in left ventricular end systolic volume (LVESV) measured by magnetic resonance imaging or computed tomography. Patients were followed clinically for 12 months and in addition patient hospitalizations and mortality was followed for 4 years after treatment. Results: After 12 months LVESV was significantly reduced in the MSC group (-10.9±15.8 mL, p<0.0001) and increased in the placebo group (6.1±16.7 mL, p<0.10). The difference between the groups was 17.0 mL (95% CI: 8.3–25.7, p=0.0002). We also found significant improvements in left ventricular ejection fraction of 6.2% (95% CI: 4.1–8.3, p<0.0001) and stroke volume of 16.1 mL (95% CI: 9.0–23.2, p<0.0001) in the MSC group vs placebo. In addition, there were significant improvements in New York Heart Association (NYHA) Class, Canadian Cardiovascular Society (CCS) class, 6-minute walking distance and quality of life in both groups. After 4 years there was a tendency towards reduced cardiac and all cause mortality. Moreover, there were significantly fewer hospital admissions for angina in the MSC group compared to placebo.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".