Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).

Name: Kaimen Rigor review — Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).
Item: Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).
Rating: 100
Author: Alpha1

Attar A, Mirhosseini SA, Mathur A, Dowlut S, Monabati A, Kasaei M, Abtahi F, Kiwan Y, Vosough M, Azarpira N

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Kaimen Rigor review — 4★ (Strong), 0 critical, 2 high issues for “Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).

Attar A, Mirhosseini SA, Mathur A, Dowlut S, Monabati A, Kasaei M, Abtahi F, Kiwan Y, Vosough M, Azarpira N

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DOI

10.1136/bmj-2024-083382

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).

Attar A, Mirhosseini SA, Mathur A, Dowlut S, Monabati A, Kasaei M, Abtahi F, Kiwan Y, Vosough M, Azarpira N

Paper source

Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 4 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit5 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and transparently reported Phase 3 randomized clinical trial of intracoronary Wharton's jelly-derived mesenchymal stem cells for post-MI heart failure prevention. The manuscript demonstrates strong rigor across all eight dimensions, with clear randomization, blinding, sample size justification, ethical approvals, and data availability. Minor copyedit issues (typos and apparent formatting errors in Table 1 and a CI in the Discussion) do not undermine the scientific integrity but warrant correction.

Both reviewers independently scored all dimensions as 'pass' with high confidence, and their evidence was consistent; no divergence required reconciliation. The study type is interventional (randomized controlled trial). Non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded from scoring. The statistics verification covered only a subset of reported tests (7 with test statistics/df or effect estimates with CIs); other p-values were not machine-verified.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 7 tests: 7 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 6 via agent-written checks.

Overstated conclusions

None found

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Checked — nothing surfaced.

11 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The paper cites prior research including the BAMI trial and a meta-analysis, acknowledges limitations of previous studies (small sample sizes, surrogate endpoints, short follow-up), and builds a logical rationale for using clinical endpoints and Wharton's jelly-derived MSCs. The hypothesis follows from the cited evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear rationale for the trial, citing prior work and addressing limitations of previous studies.

Evidence

“The BAMI trial, the largest phase 3 trial in this area, used total mortality as its primary endpoint but did not show a significant benefit, despite a significant reduction in hospital admissions for heart failure after intracoronary infusion of bone marrow derived mononuclear cells.”

Introduction ¶2Find in source

“Building on these insights, we designed a phase 3 clinical trial with long term follow-up to assess the effect of intracoronary infusion of Wharton’s jelly derived mesenchymal stem cells on the development of post-myocardial infarction heart failure.”

Introduction ¶3Find in source

PASSReviewer 2· 90% conf

The introduction establishes a clear rationale for the trial, citing prior work and addressing limitations of previous studies.

Evidence

“Despite growing interest, most clinical trials investigating stem cell therapy have been limited by small sample sizes and a focus on surrogate endpoints such as cardiac biomarkers, left ventricular ejection fraction, or scar size.”

Introduction ¶2Find in source

“These findings highlight the challenges of using mortality as a primary endpoint in cell therapy trials and suggest that incidence of heart failure may be a more appropriate and sensitive clinical outcome for evaluating efficacy.”

Introduction ¶3Find in source

“Our previous phase 2 trial showed the effectiveness of intracoronary infusion of Wharton’s jelly derived mesenchymal stem cells in improving left ventricular ejection fraction after myocardial infarction.”

Introduction ¶4Find in source

Randomization used permuted block randomization with a web-based system, and the unit is the patient. Blinding is described as single-blind with a rationale for not blinding patients (sham not permitted). Power analysis is provided with assumptions. Inclusion/exclusion criteria are pre-specified. Outlier handling is addressed through adjudication and missing data handling. Controls are the standard care group. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The trial design is rigorous with adequate randomization, blinding, sample size calculation, and pre-specified analysis population.

Evidence

“Randomisation was done centrally at the main study centre by using permuted block randomisation (block size of six), implemented through a web based randomisation system”

MethodsFind in source

“Ethics committee and institutional review board restrictions meant that a sham procedure was not permitted and patients could not be blinded to allocation. However, all researchers, clinicians, and staff members responsible for follow-up care, outcome adjudication, and data analysis remained blinded.”

MethodsFind in source

“We initially calculated the sample size to include approximately 118 patients in the intervention arm and 220 patients in the control arm to detect a difference in heart failure incidence rate, assuming rates of 3.9% in the intervention group and 12% in the control group on the basis of the results from the BAMI trial.”

MethodsFind in source

PASSReviewer 2· 85% conf

The trial design is rigorous with adequate randomization, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

“Randomisation was done centrally at the main study centre by using permuted block randomisation (block size of six), implemented through a web based randomisation system”

MethodsFind in source

“Ethics committee and institutional review board restrictions meant that a sham procedure was not permitted and patients could not be blinded to allocation.”

MethodsFind in source

Sex is reported (85% male in intervention, 79% in control). Age is reported with mean and SD. Demographics include age, sex, BMI, and comorbidities. Species/strain and housing are not applicable for a human trial. Sex justification is not applicable because both sexes are enrolled.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported for a human trial, including sex, age, and demographics.

Evidence

“The mean age of participants was similar in the two groups: 57.8 (standard deviation 10.7) years for the intervention group and 59.2 (10.9) years for the control group. Most patients were male: 85% in the intervention group and 79% in the control group.”

ResultsFind in source

PASSReviewer 2· 90% conf

Biological variables are well reported for a human trial, including sex, age, and demographics.

Evidence

“Most patients were male: 85% in the intervention group and 79% in the control group.”

ResultsFind in source

“The mean age of participants was similar in the two groups: 57.8 (standard deviation 10.7) years for the intervention group and 59.2 (10.9) years for the control group.”

ResultsFind in source

“Hypertension | 57 (42) | 117 (45) | 174 (44)”

Table 1Find in source

The study reports approval from a named ethics committee with an approval code (IR.SUMS.REC.1400.409) and states informed consent was obtained from all patients. Regulatory compliance with the Declaration of Helsinki is stated.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The study protocol received approval from the local institutional review board and ethics committee (approval code: IR.SUMS.REC.1400.409)”

EthicsFind in source

“Informed consent was obtained from all patients.”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented with a named ethics committee and approval code.

Evidence

“The study protocol received approval from the local institutional review board and ethics committee (approval code: IR.SUMS.REC.1400.409)”

EthicsFind in source

“Informed consent was obtained from all patients.”

EthicsFind in source

“The trial adhered to the principles outlined in the Declaration of Helsinki.”

EthicsFind in source

The MSCs are described with source, characterization (ISCT criteria), and quality control. The cell product is the key resource; antibodies and cell lines are not applicable. Statistical software (Stata 18) is identified.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (MSCs) is well characterized, and statistical software is identified.

Evidence

“We adhered to the minimal criteria established by the International Society for Cell and Gene Therapy (ISCT) to characterise mesenchymal stem cells.”

MethodsFind in source

“We used Stata version 18 for all statistical analysis.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (mesenchymal stem cells) is well characterized, and statistical software is identified.

Evidence

“Then, flow cytometry analysis showed the expression of surface markers CD105, CD73, and CD90, whereas the cells were negative for CD45, CD34, CD11b, CD31, and HLA-DR, aligning with ISCT standards.”

MethodsFind in source

“We used Stata version 18 for all statistical analysis.”

Statistical analysisFind in source

Tests are named (Cox regression, log-rank, Wilcoxon, etc.). Assumptions are addressed (proportional hazards tested). Exact p-values are reported. Effect sizes with CIs are reported. Software is identified. Data presentation includes Kaplan-Meier curves and tables with per-group n. Mathematical plausibility checks were not fully verifiable but no obvious errors were found.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Statistical methods are appropriate and well described, with exact p-values and effect sizes with CIs.

Evidence

“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024”

AbstractFind in source

“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89”

AbstractFind in source

PASSReviewer 2· 80% conf

Statistical methods are appropriate and well described, with exact p-values and effect sizes with confidence intervals.

Evidence

“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024”

AbstractFind in source

“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89”

AbstractFind in source

“we evaluated the proportional hazards assumption by using the global test on the basis of scaled Schoenfeld residuals”

Statistical analysisFind in source

The data availability statement provides a concrete route via Figshare with a DOI. Repository deposit is applicable and adequate. Accession numbers are not applicable for this type of data. Code sharing is not applicable as no custom code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data availability is clearly stated with a repository link.

Evidence

“De-identified individual participant data underlying the results reported in this article are available through the Figshare sharing platform ( https://doi.org/10.6084/m9.figshare.29375153.v2 ).”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability statement is concrete, with de-identified data deposited on Figshare with a DOI.

Evidence

Data availabilityFind in source

Trial registration is provided (NCT05043610). CONSORT guidelines are mentioned. All outcomes are reported, including non-significant ones. Limitations are discussed. Conclusions are proportional. Funding and COI are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The manuscript is transparent with trial registration, CONSORT adherence, and discussion of limitations.

Evidence

“ClinicalTrials.gov NCT05043610”

AbstractFind in source

“This manuscript has been prepared in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”

Methods ¶1Find in source

PASSReviewer 2· 90% conf

The manuscript is transparent, with trial registration, CONSORT adherence, and discussion of limitations.

Evidence

“ClinicalTrials.gov NCT05043610”

AbstractFind in source

“This manuscript has been prepared in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”

Methods ¶1Find in source

“The limitations of this study include the inability to do a sham procedure for the control group, which would have allowed for a double blinded study design instead of a single blinded format.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 36 references by DOI: 36 verified.

1 data/code link checked; 1 live.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, clarity, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and methodologically sound; an informed reader should weigh the minor reporting inconsistencies (Table 1 percentages, a CI typo) as low-severity issues that do not affect the conclusions. No erratum is strictly required, but correcting these typos would improve clarity. The trial's single-blind design and lack of sham control are acknowledged limitations that readers should consider when interpreting the effect size.

1.
HIGHcopyedit
In Table 1, correct the eGFR <60 mm/min/1.73 m2 row: the percentages in parentheses (134 and 1) are clearly erroneous; they should likely be 13 and 15 to match the counts (18 and 39) and overall percentage (14).
The current numbers are internally inconsistent and would mislead readers about the baseline renal function distribution.
2.
HIGHcopyedit
In the Discussion (Comparison with other studies), correct the BAMI readmission CI '8.1% (4.7% to 2.5%; n=15)' — the upper bound is lower than the lower bound; it should likely be '4.7% to 12.5%'.
An impossible confidence interval is a clear typographical error that undermines the credibility of the comparison.
3.
MEDIUMcopyedit
In Methods, Patient care, change 'conduced' to 'conducted'.
Fixes a typographical error that detracts from manuscript professionalism.
4.
MEDIUMreporting
In the main text (Methods, Sample size, randomisation, and blinding), add a sentence describing the randomization sequence generation and allocation concealment (currently only in supplementary materials).
Enhances transparency and reproducibility, as these are key CONSORT items.
5.
MEDIUMreporting
In the Results (Baseline characteristics), report the exact number of female participants in each group (not just percentages).
The small number of females is a noted limitation; exact counts would allow readers to assess sex-specific analyses.
6.
MEDIUMdata code
Add a statement in the Data availability section about the availability of statistical analysis code, even if no custom code was used.
Clarifies reproducibility and avoids ambiguity about code sharing.
7.
MEDIUMreporting
In the Abstract, add a brief note about the single-blind design and lack of sham control as a limitation (currently only in the Discussion).
Ensures the abstract accurately reflects the study's limitations for readers who only see the abstract.
8.
MEDIUMreporting
In the Results, report the exact p-values for the log-rank tests in the text (currently only in figures).
Provides precise statistical information for readers who may not access figures.
9.
MEDIUMreporting
In the Methods or Supplementary, provide the full adjusted models (with all covariates) in the main text rather than only in supplementary materials.
Improves transparency of the primary analysis and allows readers to assess confounding control.
10.
MEDIUMreporting
In Table 1, report the number of patients with missing data for each covariate, as some denominators are less than the group total.
Clarifies the extent of missing data and how it was handled.
11.
LOWreporting
Add a CONSORT checklist as a supplementary file and specify the exact version of CONSORT used.
Confirms adherence to reporting guidelines and facilitates reviewer/reader verification.
12.
LOWdata code
Provide a data dictionary for the Figshare dataset to facilitate reuse.
Enhances the usability of the deposited data for independent re-analysis.
13.
LOWreporting
In the Discussion, add a note about the generalizability of the findings given the specific population (first STEMI, LVEF<40%) and the multi-center setting.
Helps readers interpret the applicability of the results to broader patient populations.

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Read alongside

Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).

Attar A, Mirhosseini SA, Mathur A, Dowlut S, Monabati A, Kasaei M, Abtahi F, Kiwan Y, Vosough M, Azarpira N

Read full text (PMC)

DOI

10.1136/bmj-2024-083382

Share this Kaimen Rigor review

Post on X Share on LinkedIn Share via Email

Embed this Rigor badge

<a href="https://alpha1science.com/verify/faab8356-55db-4c7a-8c8e-bfdd83a38e9f" target="_blank" rel="noopener">
  <img src="https://alpha1science.com/verify/faab8356-55db-4c7a-8c8e-bfdd83a38e9f/badge" alt="Kaimen Rigor review — 4★ (Strong), 0 critical, 2 high issues for “Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).”" width="440" height="104" style="max-width:100%;height:auto" />
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Record fingerprint

1f146c8141cbad92ef1985d7f5d0d0d51dedd9eba19f541534eb33b561bcd09d

Verify via API

Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 4 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit5 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 7 tests: 7 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 6 via agent-written checks.

Overstated conclusions

None found

Checked — nothing surfaced.

11 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear rationale for the trial, citing prior work and addressing limitations of previous studies.

Evidence

Introduction ¶2Find in source

Introduction ¶3Find in source

PASSReviewer 2· 90% conf

The introduction establishes a clear rationale for the trial, citing prior work and addressing limitations of previous studies.

Evidence

Introduction ¶2Find in source

Introduction ¶3Find in source

Introduction ¶4Find in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The trial design is rigorous with adequate randomization, blinding, sample size calculation, and pre-specified analysis population.

Evidence

“Randomisation was done centrally at the main study centre by using permuted block randomisation (block size of six), implemented through a web based randomisation system”

MethodsFind in source

PASSReviewer 2· 85% conf

The trial design is rigorous with adequate randomization, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

“Randomisation was done centrally at the main study centre by using permuted block randomisation (block size of six), implemented through a web based randomisation system”

MethodsFind in source

“Ethics committee and institutional review board restrictions meant that a sham procedure was not permitted and patients could not be blinded to allocation.”

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported for a human trial, including sex, age, and demographics.

Evidence

ResultsFind in source

PASSReviewer 2· 90% conf

Biological variables are well reported for a human trial, including sex, age, and demographics.

Evidence

“Most patients were male: 85% in the intervention group and 79% in the control group.”

ResultsFind in source

“The mean age of participants was similar in the two groups: 57.8 (standard deviation 10.7) years for the intervention group and 59.2 (10.9) years for the control group.”

ResultsFind in source

“Hypertension | 57 (42) | 117 (45) | 174 (44)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The study protocol received approval from the local institutional review board and ethics committee (approval code: IR.SUMS.REC.1400.409)”

EthicsFind in source

“Informed consent was obtained from all patients.”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented with a named ethics committee and approval code.

Evidence

“The study protocol received approval from the local institutional review board and ethics committee (approval code: IR.SUMS.REC.1400.409)”

EthicsFind in source

“Informed consent was obtained from all patients.”

EthicsFind in source

“The trial adhered to the principles outlined in the Declaration of Helsinki.”

EthicsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (MSCs) is well characterized, and statistical software is identified.

Evidence

“We adhered to the minimal criteria established by the International Society for Cell and Gene Therapy (ISCT) to characterise mesenchymal stem cells.”

MethodsFind in source

“We used Stata version 18 for all statistical analysis.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (mesenchymal stem cells) is well characterized, and statistical software is identified.

Evidence

MethodsFind in source

“We used Stata version 18 for all statistical analysis.”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Statistical methods are appropriate and well described, with exact p-values and effect sizes with CIs.

Evidence

“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024”

AbstractFind in source

“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89”

AbstractFind in source

PASSReviewer 2· 80% conf

Statistical methods are appropriate and well described, with exact p-values and effect sizes with confidence intervals.

Evidence

“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024”

AbstractFind in source

“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89”

AbstractFind in source

“we evaluated the proportional hazards assumption by using the global test on the basis of scaled Schoenfeld residuals”

Statistical analysisFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data availability is clearly stated with a repository link.

Evidence

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability statement is concrete, with de-identified data deposited on Figshare with a DOI.

Evidence

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The manuscript is transparent with trial registration, CONSORT adherence, and discussion of limitations.

Evidence

“ClinicalTrials.gov NCT05043610”

AbstractFind in source

“This manuscript has been prepared in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”

Methods ¶1Find in source

PASSReviewer 2· 90% conf

The manuscript is transparent, with trial registration, CONSORT adherence, and discussion of limitations.

Evidence

“ClinicalTrials.gov NCT05043610”

AbstractFind in source

“This manuscript has been prepared in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”

Methods ¶1Find in source

“The limitations of this study include the inability to do a sham procedure for the control group, which would have allowed for a double blinded study design instead of a single blinded format.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 36 references by DOI: 36 verified.

1 data/code link checked; 1 live.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, clarity, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHcopyedit
In Table 1, correct the eGFR <60 mm/min/1.73 m2 row: the percentages in parentheses (134 and 1) are clearly erroneous; they should likely be 13 and 15 to match the counts (18 and 39) and overall percentage (14).
The current numbers are internally inconsistent and would mislead readers about the baseline renal function distribution.
2.
HIGHcopyedit
In the Discussion (Comparison with other studies), correct the BAMI readmission CI '8.1% (4.7% to 2.5%; n=15)' — the upper bound is lower than the lower bound; it should likely be '4.7% to 12.5%'.
An impossible confidence interval is a clear typographical error that undermines the credibility of the comparison.
3.
MEDIUMcopyedit
In Methods, Patient care, change 'conduced' to 'conducted'.
Fixes a typographical error that detracts from manuscript professionalism.
4.
MEDIUMreporting
In the main text (Methods, Sample size, randomisation, and blinding), add a sentence describing the randomization sequence generation and allocation concealment (currently only in supplementary materials).
Enhances transparency and reproducibility, as these are key CONSORT items.
5.
MEDIUMreporting
In the Results (Baseline characteristics), report the exact number of female participants in each group (not just percentages).
The small number of females is a noted limitation; exact counts would allow readers to assess sex-specific analyses.
6.
MEDIUMdata code
Add a statement in the Data availability section about the availability of statistical analysis code, even if no custom code was used.
Clarifies reproducibility and avoids ambiguity about code sharing.
7.
MEDIUMreporting
In the Abstract, add a brief note about the single-blind design and lack of sham control as a limitation (currently only in the Discussion).
Ensures the abstract accurately reflects the study's limitations for readers who only see the abstract.
8.
MEDIUMreporting
In the Results, report the exact p-values for the log-rank tests in the text (currently only in figures).
Provides precise statistical information for readers who may not access figures.
9.
MEDIUMreporting
In the Methods or Supplementary, provide the full adjusted models (with all covariates) in the main text rather than only in supplementary materials.
Improves transparency of the primary analysis and allows readers to assess confounding control.
10.
MEDIUMreporting
In Table 1, report the number of patients with missing data for each covariate, as some denominators are less than the group total.
Clarifies the extent of missing data and how it was handled.
11.
LOWreporting
Add a CONSORT checklist as a supplementary file and specify the exact version of CONSORT used.
Confirms adherence to reporting guidelines and facilitates reviewer/reader verification.
12.
LOWdata code
Provide a data dictionary for the Figshare dataset to facilitate reuse.
Enhances the usability of the deposited data for independent re-analysis.
13.
LOWreporting
In the Discussion, add a note about the generalizability of the findings given the specific population (first STEMI, LVEF<40%) and the multi-center setting.
Helps readers interpret the applicability of the results to broader patient populations.

Full text (59,492 chars)Analyzed: Aug 15, 2026