Faculty Opinions recommendation of Gene therapy for pain: results of a phase I clinical trial.
Bibliographic record
Abstract
Objective-Preclinical evidence indicates that gene transfer to the dorsal root ganglion (DRG) using replication defective herpes simplex virus (HSV)-based vectors can reduce pain-related behavior in animal models of pain.This clinical trial was carried out to assess the safety and explore the potential efficacy of this approach in humans.Methods-We conducted a multicenter, dose-escalation, Phase I clinical trial of NP2, a replication defective HSV-based vector expressing human preproenkephalin (PENK) in subjects with intractable focal pain caused by cancer.NP2 was injected intradermally into the dermatome(s) corresponding to the radicular distribution of pain.The primary outcome was safety.As secondary measures, efficacy of pain relief was assessed using a numeric rating scale (NRS), the Short Form McGill Pain Questionnaire (SF-MPQ) and concurrent opiate usage.Results-Ten subjects with moderate to severe intractable pain despite treatment with more than 200 mg/day of morphine (or equivalent) were enrolled into the study.Treatment was well tolerated with no study agent-related serious adverse events (SAE) observed at any point in the study.Subjects receiving the low dose of NP2 reported no substantive change in pain.Subjects in the middle and high dose cohorts reported pain relief as assessed by NRS and SF-MPQ.Interpretation-Treatment of intractable pain with NP2 was well tolerated.There were no placebo controls in this relatively small study, but the dose-responsive analgesic effects suggest that NP2 may be effective in reducing pain and warrants further clinical investigation.
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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 | 0.004 | 0.010 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 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".