009 Effect of Transendocardial Stem Cell Injection on Erectile Function in Men with Cardiomyopathy: Results from the TRIDENT and TAC-HFT Trials.
Bibliographic record
Abstract
There is growing interest in the use of stem cell therapy (SCT) for erectile dysfunction (ED). Human studies thus far have been limited to phase I trials with few patients receiving SCT via intracavernosal injections. The effect of systemically delivered SCT and its effects on ED have not yet been explored in the context of a clinical trial. To determine the effect of transendocardial stem cell injection on erectile function in men with ED and cardiomyopathy. We used International Index of Erectile Function (IIEF) scores collected from men enrolled in two separate randomized controlled trials: (1) 2014 TAC-HFT and (2) 2017 TRIDENT. These trials recruited patients with ischemic cardiomyopathy and ejection fraction less than 50%. Inclusion and exclusion criteria were identical in both studies. Primary intervention in both trials was blinded transendocardial injection of either stem cells or placebo via cardiac catheterization. Follow up was for 1 year. IIEF data was collected at baseline and at 3, 6 and 12 months. Men in the TRIDENT trial received varying doses of allogenic mesenchymal stem cells (MSC) (20 or 100 million cells), and men in the TAC-HFT trial received either placebo, autologous MSCs or autologous bone marrow mononuclear cells (BMCs). We performed subgroup analyses evaluating allogenic vs. autologous SC sources, and evaluated the erectile function among men who received SC injections by stem cell dose. We used descriptive and analytic statistics to analyze the data.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".