Abstract WP120: Granuloctye-Colony Stimulating Factor in Ischemic Stroke Trial (GIST): A Pilot Study
Bibliographic record
Abstract
Introduction: Granulocyte-colony stimulating factor (G-CSF) is upregulated in models of cerebral ischemia. This may promote hematopoietic stem cell (HSC) mediated central nervous system repair. We hypothesize that exogenous G-CSF may promote recovery after acute ischemic stroke. We examined the safety and feasibility of this therapy with a double-blind, randomized pilot study of G-CSF in patients with acute stroke. Methods: Patients with ischemic stroke and motor deficits greater than 2 on the National Institutes of Health Stroke Scale (NIHSS) were randomized to receive a four-day course of G-CSF (10 μg/kg sc) or matching placebo within ten days of stroke occurrence, followed by a second cycle after six weeks. Primary outcomes were safety measures including recurrent stroke, mortality, toxicity as measured by the NCI Common Toxicity Scale, and worsening of disability as measured by modified Rankin Scale (mRS), Barthel index, NIHSS and Glasgow Outcome Scale (GOS). Testing occurred at 1.5, 3, 6 and 12 months after treatment. MRI, CT perfusion and functional MRI were obtained at 3 months with repeat MRI scan at 12 months, and neuropsychological testing was conducted at 6 and 12 months. Results: Nine patients were randomized; mean pre-treatment NIH Stroke Scale was 8.8. Elevation of circulating leukocytes and CD34+ cells were observed after G-CSF administration compared to placebo. Adverse events including diarrhea, dehydration, bone pain, and asymptomatic leukocytosis were seen more frequently in the G-CSF treated cohort, but there were no recurrent strokes or deaths in either group. Disability did not worsen in any patients, with no significant change in median mRS, NIHSS, GOS or Barthel index between groups at 1.5, 3, 6 or 12 months after treatment. No significant changes in neuropsychological testing or imaging parameters were observed. Conclusions: G-CSF administration in ischemic stroke patients appears to be safe and feasible, with no increase in mortality or worsening of disability observed in this pilot study. Larger randomized trials would be needed to determine efficacy of this potential novel therapy for stroke recovery.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 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".