Human study PLS-00134

Recombinant human thymosin beta 4 improves ischemic cardiac dysfunction in mice and patients with acute ST-segment elevation myocardial infarction after reperfusion.

Randomized controlled trial · 96 participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Only the abstract was available. Essential methods may be missing, which limits what can be judged.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

Recombinant human thymosin beta 4 improves ischemic cardiac dysfunction in mice and patients with acute ST-segment elevation myocardial infarction after reperfusion.primary · Cardiovascular research · 2025-12-01 · PMID 41229390 · DOI

Design and participants

Design: Randomized controlled trial
Population: Patients with acute ST-segment elevation myocardial infarction after reperfusion by primary percutaneous coronary intervention.
Conditions: ST-segment elevation myocardial infarction, Myocardial ischemia/reperfusion injury
Setting: Not stated; post-PCI care of STEMI patients.
Planned enrollment (registry): Not reported
Enrolled: 96
Randomized: 96
Completed follow-up: Not reported
Funding: PubMed lists the publication type Research Support, Non-U.S. Gov't; specific funders are not named.
Authors’ conflicts: Not reported in the record.

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

rhTB4 (intervention) · thymosin-beta-4 · Recombinant human thymosin beta 4 (rhTB4) · not stated · Started after PCI; a subgroup got the first dose within 8 h of PCI. Treatment duration not stated for the human trial. · Not reported assigned
Placebo (comparator) · Placebo · placebo · not stated · not stated · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Infarcted area

unclear outcome · surrogate · 90-day follow-up · Size of the infarcted area; the measurement method is not stated in the abstract.

rhTB4 vs Placebo: narrative — Overall difference in infarcted area between rhTB4 and placebo was not significant (n = 96).
rhTB4 vs Placebo: narrative — Infarcted area was significantly smaller with rhTB4 than placebo in the subgroup given the first dose within 8 h after PCI (n = 43 in that rhTB4 group).

Adverse events

None reported. That is not evidence of safety.

Monitoring: Not reported in the abstract.

The authors concluded (paraphrased): rhTB4 mitigates cardiac dysfunction in an ErbB2-dependent manner in mice. The trial supports translational potential, mainly with early use after PCI, but the overall effect on infarct size was not significant and further rigorous randomized studies are needed.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

abstract only: Only the abstract is available. Randomization, blinding, attrition and measurement details are not reported.
selective reporting: The positive finding comes from a subgroup treated within 8 h after PCI, while the overall comparison of all 96 patients was not significant.
inappropriate endpoint: Infarcted area is an imaging surrogate. No clinical events, symptoms or function outcomes are reported for the human trial.
small or imprecise: 96 patients were randomized and the highlighted subgroup had only 43 patients in the rhTB4 group. No effect estimates or intervals are given.
other: No adverse event or tolerability data for the human trial are reported in the abstract, so safety cannot be assessed.

Infarcted area: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	The abstract says the trial was randomized but gives no details on sequence generation, allocation concealment or baseline balance.
Deviations from intended interventions	Some concerns	Described as double-blind and placebo-controlled, but adherence, deviations and the analysis population are not described.
Missing outcome data	Some concerns	The number completing 90-day follow-up and the handling of missing infarct measurements are not reported in the abstract.
Measurement of the outcome	Some concerns	The method for measuring infarcted area is not stated. Double-blinding is claimed but assessor blinding is not detailed.
Selection of the reported result	High risk of bias	The abstract emphasizes a significant result in a subgroup defined by dosing within 8 h, while the overall comparison was non-significant. This suggests selection of the reported analysis.

High risk because the highlighted result is a subgroup analysis next to a null overall result, and the abstract-only report leaves other domains uncertain.

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Claims this study informs

Improves dry eye signs and symptoms: not eligible (wrong population) for “Ocular discomfort and corneal staining”
Is safe for human administration: not eligible (insufficient data) for “Adverse events, serious adverse events and discontinuations”

Where each value comes from

arms: PMID 41229390, abstract (Methods and results, rhTB4 vs placebo trial sentence) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 41229390, abstract (Conclusion section) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 41229390, abstract (Methods and results, sentence on randomized placebo-controlled double-blind trial) · extracted by AI (automated, not verified by a person) · abstract only
funding: PMID 41229390, citation (PubMed publication types) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 41229390, abstract (Methods and results and Conclusion, subgroup vs overall result) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 41229390, abstract (Methods and results, infarcted areas at 90-day follow-up) · extracted by AI (automated, not verified by a person) · abstract only
participants: PMID 41229390, abstract (Methods and results, final two sentences (n = 96; n = 43)) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 41229390, abstract (Aims and Methods and results, STEMI patients post-PCI) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 41229390, abstract (Methods and results, last two sentences) · extracted by AI (automated, not verified by a person) · abstract only

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).