Analysis of Recruitment and Outcomes in the Phase I/IIa Cethrin Clinical Trial for Acute Spinal Cord Injury
Bibliographic record
Abstract
The Cethrin™ clinical trial was an open-label Phase I/IIa trial undertaken to assess the safety, tolerability, and neurological status of patients with acute spinal cord injury (SCI) who were treated with escalating doses of Cethrin, a therapeutic protein drug that inactivates Rho. Recruitment, motor scores, and data on adverse events of treated patients have been reported (Fehlings et al.).(24) While determining efficacy in a small open-label study is not possible, it is important to understand if the results warrant further clinical study, because clinical trial failures have wide ranging impacts. We have examined the clinical data to analyze time to recruitment and sensory outcomes, and compared the outcomes with available registry and placebo data. The average time to recruitment was 52 h, and there was a trend to improved sensory scores in treated patients with thoracic injury. An analysis of patients who recovered two motor levels or more suggests that there may be a larger responder population in the Cethrin-treated participants than in historical controls. We examined time to recruitment and found that the extent of motor and sensory recovery could not be explained by early surgery, and the Cethrin-treated patients showed favorable trends compared with the Surgical Timing in Acute SCI data. The trends reported here indicate that further study of Cethrin is warranted and provide useful guidance to establish effective clinical protocols.
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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 | 0.025 | 0.021 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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 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".