Human study PLS-00167

Safety and efficacy of autologous thymosin β4 pre-treated endothelial progenitor cell transplantation in patients with acute ST segment elevation myocardial infarction: A pilot study.

Randomized controlled trial · 10 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.

Safety and efficacy of autologous thymosin β4 pre-treated endothelial progenitor cell transplantation in patients with acute ST segment elevation myocardial infarction: A pilot study.primary · Cytotherapy · 2016-06-07 · PMID 27288307 · DOI

Design and participants

Design: Randomized controlled trial
Population: Patients with acute ST segment elevation myocardial infarction (STEMI).
Conditions: Acute ST segment elevation myocardial infarction
Planned enrollment (registry): Not reported
Enrolled: 10
Randomized: 10
Completed follow-up: Not reported

Intervention and comparator

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

Tβ4-pre-treated EPC transplantation (experimental group) (intervention) · thymosin-beta-4 (combination) · Autologous endothelial progenitor cells pre-treated with thymosin β4 24 hours before transplantation; Tβ4 was used ex vivo to prime the cells. · Cell transplantation (route not stated) · Single transplantation; follow-up 6 months · 5 assigned
EPC transplantation (control group) (comparator) · Autologous endothelial progenitor cell transplantation without Tβ4 pre-treatment. · active · Cell transplantation (route not stated) · Single transplantation; follow-up 6 months · 5 assigned

What the authors reported

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

6-minute walking distance

unclear outcome · patient-important · Before and 6 months after intervention · 6-min walking test

EPC transplantation (control group): change from baseline 38.2 — Average 6MWD increased by 38.2 m (from 263 ± 42 m to 302 ± 34 m) at 6 months
Tβ4-pre-treated EPC transplantation (experimental group): change from baseline 75.7 — Average 6MWD increased by 75.7 m (from 264 ± 42 m to 340 ± 44 m) at 6 months
Tβ4-pre-treated EPC transplantation (experimental group) vs EPC transplantation (control group): mean difference 37.5 (95% CI 28.7 to 56.3) — Average difference in 6MWD of 37.5 m favouring experimental group; p-value truncated in record

Left ventricular function

unclear outcome · surrogate · Before and 6 months after intervention · Echocardiography and emission computed tomography

Tβ4-pre-treated EPC transplantation (experimental group) vs EPC transplantation (control group): narrative — Authors state Tβ4-optimized EPC transplantation might have beneficial effects on LV function; no numeric data in record

Feasibility and safety

unclear outcome · safety · 6 months · Not described in record

Tβ4-pre-treated EPC transplantation (experimental group): narrative — Authors state Tβ4-optimized EPC transplantation appeared feasible and safe; no adverse event data reported

Adverse events

None reported. That is not evidence of safety.

Monitoring: Not described; abstract states only that the procedure appeared feasible and safe.

The authors concluded (paraphrased): In this pilot study, transplantation of Tβ4-optimized endothelial progenitor cells appeared feasible and safe in STEMI patients and might improve exercise capacity and left ventricular function.

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

small or imprecise: Only 10 patients were randomized, 5 per group, so estimates are highly imprecise.
abstract only: Only the abstract is available and it is truncated, so methods, the p-value and LV results are missing.
inadequate blinding: Blinding of patients and assessors is not described; the 6-min walk test is effort-dependent.
other: Tβ4 was only used ex vivo to prime cells; patients did not receive Tβ4 directly, which limits inference about Tβ4 itself.
selective reporting: No adverse event data are reported despite a safety claim, and the LV function results are not given numerically.
inappropriate population: The intervention is a cell product pre-treated with Tβ4, not Tβ4 itself, and the comparator is EPCs without Tβ4, so the Tβ4 effect cannot be isolated from cell therapy in general.
short follow up: Follow-up was 6 months, which limits conclusions on durability and longer-term safety.

6-minute walking distance: 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	Abstract says patients were randomized but gives no sequence generation or concealment method.
Deviations from intended interventions	Some concerns	Blinding of participants and personnel and adherence to the transplant procedure are not described.
Missing outcome data	Some concerns	Numbers analysed at 6 months are not reported in the abstract.
Measurement of the outcome	Some concerns	The 6-min walk is effort-dependent and assessor blinding is not stated.
Selection of the reported result	Some concerns	No registration or protocol is cited and the p-value is truncated in the record.

Concerns in every domain from an abstract-only report of a tiny trial add up to high risk.

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.

Left ventricular function: 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	Randomization is stated but its method and concealment are not described in the abstract.
Deviations from intended interventions	Some concerns	No information on blinding or on deviations from the intended intervention.
Missing outcome data	Some concerns	Numbers with echocardiography/ECT at 6 months are not reported.
Measurement of the outcome	Some concerns	Blinding of the echocardiography and ECT readers is not stated.
Selection of the reported result	High risk of bias	Only a narrative 'might have beneficial effects' statement is given, with no numeric LV results.

The reported-result domain is high because LV data are absent; the other domains raise concerns.

Feasibility and safety: 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 randomization method is not described in the abstract.
Deviations from intended interventions	Some concerns	Blinding and protocol adherence are not described.
Missing outcome data	Some concerns	Follow-up completeness for safety is not reported.
Measurement of the outcome	High risk of bias	No method for collecting or ascertaining adverse events is described.
Selection of the reported result	High risk of bias	The safety claim is stated only in the discussion, with no adverse event counts.

The safety conclusion rests on an unsupported narrative statement with no AE data.

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: eligible for “Adverse events, serious adverse events and discontinuations”, indirect evidence

Insufficient information to assess Adverse events, serious adverse events and discontinuations

Where each value comes from

arms: PMID 27288307, abstract (Methods, sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 27288307, abstract (Discussion, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 27288307, abstract (Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 27288307, abstract (Methods and Results) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 27288307, abstract (Methods, sentence 3) · extracted by AI (automated, not verified by a person) · abstract only
participants: PMID 27288307, abstract (Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 27288307, abstract (Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 27288307, abstract (Results, sentence 1) · 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).