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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: 84
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 — 1.25★ (Critical), 0 critical, 8 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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This rigor review was examined and confirmed by Alpha1 Editorial · August 5, 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)

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 5, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

1.25 / 5

Critical — serious problems across many checks

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×5−2.5★
ClaimsUnsupported claim (uncorroborated)−0.5★
ReportingData & code availability not met−0.5★
ReportingStatistical analysis partially met−0.25★

Model-reported confidence: moderateReviewer agreement: moderateEngine: 7.15.0Source: full text

Biggest issues

01Conclusion not supported by the paper’s own evidence
highOverreachreviewer-assessedFull detail
No adverse events were noticed.
“No adverse events were noticed.”
Adverse events and safety
02Data and code not shared
highDisclosurereviewer-assessedFull detail
The data availability statement is incomplete (appears truncated), and no code is shared. For a clinical trial, a proper data availability statement is required.
“Data availability statement De-id”
References
03Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
The safety section states 'No adverse events were noticed' although the trial reports 16 deaths, 61 heart-failure events (9+37 incidence + 3+24 readmissions counted separately), and 22 MI readmissions across groups; unless qualified to procedure-related events, this is a direct contradiction.
“No adverse events were noticed.”
Adverse events and safety
04Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
In Table 2, HF-incidence rates do not match the event counts/person-years: 9/314.47 gives 2.86% (reported 2.77%) and 37/551.88 gives 6.70% (reported 6.48%). The reported rates correspond to the readmission-to-HF person-years (325.39 and 570.98).
“9/314.47 | 5.74 (1.99 to 9.50) | 2.77 (1.44 to 5.32) | 37/551.88 | 16.08 (10.90 to 21.27 | 6.48 (4.69 to 8.94)”
Table 2

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 203AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 106CopyeditCopyediting

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.

The paper reports a well-designed Phase 3 randomized trial with clear methods and transparent reporting. However, several arithmetic inconsistencies in key tables (incidence rates, hazard ratio) and a truncated data availability statement reduce the robustness of the published record. The missing details for the investigational product (manufacturer, antibody clones, mycoplasma testing) also limit reproducibility.

Eight dimensions evaluated, all applicable. The three independent reviewer runs converged on most dimensions; minor divergences on study design (power analysis adequacy), biological variables (demographics completeness), and key resources (product detail adequacy) were resolved by weighing the specific evidence. The statistics recomputation checked 18 tests and found all consistent, but the arithmetic errors in Table 2 and the HR inconsistency are not covered by that check.

Numerical inconsistencies

1 finding · worst medium

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 14 tests: 14 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 12 via agent-written checks.

Overstated conclusions

2 findings · worst high

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.

Conclusions not supported by the paper’s own evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

12 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

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

Data authenticity concerns

2 findings · worst low

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.

Data look implausibly cleanAssessed
Other integrity concernAssessed

5 integrity concerns flagged (0 high).

Reporting gaps

2 findings · worst high

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.

Data and code not sharedAssessed
Statistical reporting gaps (tests, assumptions, effect sizes)Assessed

Eight Dimensions6 pass · 1 warn · 1 fail

The introduction cites the BAMI trial's negative mortality result and points to heart-failure incidence as a more sensitive endpoint, references a prior phase 2 trial of the same cells, and a meta-analysis. Limitations of prior work are explicitly acknowledged (small samples, surrogate endpoints, short follow-up). The rationale logically links stem-cell biology and prior evidence to the trial's objectives.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study establishes a clear scientific foundation by citing prior trials (BAMI, REPAIR-AMI, a meta-analysis) and its own phase 2 work, and by justifying the choice of heart-failure incidence as a clinical endpoint.

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

“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

“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

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing prior research, providing a logical rationale, 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 ¶2

“Mesenchymal stem cells have shown greater promise than bone marrow derived mononuclear cells for treating patients with acute myocardial infarction.”

Introduction ¶3

paraphrase[Introduction, last paragraph]

“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.”

PASSReviewer 3· 95% conf

The introduction establishes a clear rationale from prior stem-cell trials (BAMI, REPAIR-AMI, meta-analyses) and explains how PREVENT-TAHA8 addresses their limitations (clinical endpoints, follow-up duration, sample size).

Evidence

“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

“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

“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”

Introduction

Randomization method (permuted block, size six, web-based) and unit (patient) are stated. Blinding is single-blind with a stated rationale (sham not permitted) and explicit blinding of outcome assessors and analysts. Sample size was calculated a priori with assumed event rates and an events requirement. Inclusion/exclusion criteria are pre-specified. The analysis population and handling of withdrawals are described. Applicable sub-criteria are all adequate.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial uses a sound design with central permuted-block randomization, clear blinding of outcome assessors, a priori sample-size calculation, pre-specified inclusion/exclusion criteria, and a defined 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”

Methods

“However, all researchers, clinicians, and staff members responsible for follow-up care, outcome adjudication, and data analysis remained blinded.”

Methods

“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”

Methods

PASSReviewer 2· 90% conf

The study design is adequately described with randomization, blinding, sample size calculation, and 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 ( https://www.sealedenvelope.com/randomisation/simulation/ ).”

Methods

“However, all researchers, clinicians, and staff members responsible for follow-up care, outcome adjudication, and data analysis remained blinded.”

Same section

PASSReviewer 3· 90% conf

Core design elements for a human RCT are reported: central permuted-block randomisation, explicit blinding strategy, pre-specified eligibility criteria, analysis population, and sample-size planning; alpha/power are not explicitly stated, though details are referenced to supplementary materials.

Evidence

Methods

“However, all researchers, clinicians, and staff members responsible for follow-up care, outcome adjudication, and data analysis remained blinded.”

Methods

The paper reports sex, age, and various health indicators in baseline characteristics. Both sexes are included, so sex justification is not required. All applicable sub-criteria are adequately reported.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported for a human trial: sex, age, BMI, and comprehensive medical history are given, and the cohort is mixed-sex.

Evidence

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

Results

“Mean (SD) age, years | 57.8 (10.7) | 59.2 (10.9) | 58.7 (10.8)”

Table 1

PASSReviewer 2· 95% conf

Sex, age, health status, and demographics are adequately reported in Table 1.

Evidence

paraphrase[Table 1]

“Male sex: 115 (85%) intervention, 205 (79%) control.”

paraphrase[Table 1]

“Mean (SD) age, years: 57.8 (10.7) intervention, 59.2 (10.9) control.”

paraphrase[Table 1]

“Table 1 includes smoking, BMI, medical history, and baseline health indicators.”

PASSReviewer 3· 80% conf

Sex, age, body-mass index, and extensive medical history are reported; race/ethnicity is not reported.

Evidence

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

Results

“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.”

Results

absence[Table 1 / baseline characteristics]

Race/ethnicity is not reported.

The protocol received approval from a named ethics committee with approval code IR.SUMS.REC.1400.409. Informed consent was obtained from all patients, and the consent process is described. Regulatory compliance with the Declaration of Helsinki is stated. All applicable criteria are adequate.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval with a protocol number, informed consent, and Declaration of Helsinki compliance are all explicitly stated.

Evidence

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

Ethics

“Informed consent was obtained from all patients.”

Ethics

PASSReviewer 2· 95% conf

Ethics approval, informed consent, and regulatory compliance are clearly stated.

Evidence

paraphrase[Ethics statements]

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

“All patients gave informed consent.”

Methods

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

Ethics

PASSReviewer 3· 85% conf

Ethical approval, informed consent, and Declaration of Helsinki compliance are reported with an approval code and trial registration.

Evidence

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

Ethics

“Informed consent was obtained from all patients.”

Ethics

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

Ethics

The paper describes the source, isolation, characterization, and quality control of Wharton's jelly derived MSCs. Stata version 18 is identified for statistical analysis. No other biological resources are applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational biologic (MSCs) is well characterized, and the statistical software is identified; the bench-style criteria are not applicable to this clinical trial.

Evidence

“Clinical grade, current good manufacturing practice certified allogenic human Wharton’s jelly derived mesenchymal stem cells were transported to the hospital on the day of the infusion and suspended in 0.9% saline.”

Methods

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

Statistical analysis

PASSReviewer 2· 90% conf

The investigational product (MSCs) is described in detail, and statistical software is identified.

Evidence

paraphrase[Methods, Intracoronary infusion of mesenchymal stem cells]

“Intracoronary infusion of an estimated 10 7 Wharton's jelly derived mesenchymal stem cells in the cardiac catheterisation laboratory. Clinical grade, current good manufacturing practice certified allogenic human Wharton's jelly derived mesenchymal stem cells were transported to the hospital on the day of the infusion and suspended in 0.9% saline.”

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

Statistical analysis

WARNReviewer 3· 70% conf

The investigational MSC product is described in terms of source, dose, and delivery, and Stata 18 is identified, but the product's manufacturer/lot, antibody identifiers for flow cytometry, and mycoplasma testing are not reported.

Evidence

Methods

“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”

Methods

absence[Methods, 'Intracoronary infusion of mesenchymal stem cells']

Mycoplasma testing is not reported.

Statistical tests are named extensively, exact p-values are given for most endpoints, effect sizes with CIs are reported, software is identified, and data presentation follows the clinical-trial idiom. However, Table 1 contains an arithmetic impossibility: 'eGFR <60 mm/min/1.73 m2 | 18 (134) | 39 (1) | 57 (14)' — the percentages 134% and 1% are impossible for n=136 and n=260. This is a demonstrable data-reporting error, so the dimension is rated warn rather than pass.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationINADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityWARN

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

The statistical analysis is generally rigorous and well reported, but a demonstrable typographical error in Table 1 (impossible percentages for eGFR <60) lowers the overall rating.

Evidence

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

Abstract

“eGFR <60 mm/min/1.73 m 2 | 18 (134) | 39 (1) | 57 (14)”

Table 1

WARNReviewer 2· 80% conf

Statistical tests are named, assumptions verified, exact p-values and effect sizes with CIs reported, software identified, and data presentation adequate. However, a arithmetic discrepancy in the reported incidence rate for the primary endpoint raises concern.

Evidence

paraphrase[Table 2]

“HF incidence (development): Intervention: 9 events/314.47 person-years, annual incidence rate 2.77% (1.44 to 5.32); Control: 37 events/551.88 person-years, annual incidence rate 6.48% (4.69 to 8.94).”

paraphrase[Abstract, Results]

“P=0.024, P=0.015, P=0.012, etc.”

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

Results

WARNReviewer 3· 75% conf

Statistical methods are comprehensive and mostly well reported, but there is an arithmetic inconsistency between the HF-incidence event counts/person-years and the reported rates in Table 2/Abstract, and the composite HR is reported as both 0.39 and 0.40.

Evidence

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

Statistical analysis

“9/314.47 | 5.74 (1.99 to 9.50) | 2.77 (1.44 to 5.32) | 37/551.88 | 16.08 (10.90 to 21.27 | 6.48 (4.69 to 8.94)”

Table 2

“0.39, 0.19 to 0.82; P=0.012”

Abstract

The paper ends with 'Data availability statement De-id' which is incomplete and does not provide a concrete access route. No repository deposit or accession numbers are provided. Code sharing is not applicable but the lack of a proper data availability statement constitutes a fail.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 80% conf

A data availability statement is present but truncated/vague, and no repository deposit or code sharing is reported.

Evidence

“Data availability statement De-id”

Data availability

“An interactive version of this graphic and downloadable data are available at https://public.flourish.studio/visualisation/25452455/”

Results

FAILReviewer 2· 95% conf

The data availability statement is incomplete (appears truncated), and no code is shared. For a clinical trial, a proper data availability statement is required.

Evidence

“Data availability statement De-id”

References

WARNReviewer 3· 60% conf

A data availability statement begins but its full text is not visible in the provided excerpt; figure-level data are shared via Flourish URLs, but no repository/accession or code is identified.

Evidence

“Data availability statement De-id”

Data availability

“An interactive version of this graphic and downloadable data are available at https://public.flourish.studio/visualisation/25452455/”

Results

absence[Methods, 'Statistical analysis']

Custom analysis code is not shared.

All seven applicable sub-criteria are adequately reported. The trial is registered, CONSORT guidelines are followed, all pre-specified outcomes are reported, limitations are discussed, conclusions are proportional, and funding and competing interests are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The manuscript is transparent: trial registration, CONSORT adherence, complete reporting of outcomes, limitations, and funding/COI statements are all present.

Evidence

“Trial registration ClinicalTrials.gov NCT05043610 .”

Abstract

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

Methods

“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.”

Limitations

PASSReviewer 2· 95% conf

The paper is well-reported with detailed methods, trial registration, CONSORT adherence, all outcomes reported, limitations discussed, proportional conclusions, and funding/COI statements.

Evidence

“Trial registration ClinicalTrials.gov NCT05043610 .”

Abstract

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

Methods

paraphrase[Discussion, Strengths and limitations]

“The limitations of this study include the inability to do a sham procedure for the control group...”

PASSReviewer 3· 90% conf

The manuscript is transparent: registered, CONSORT-adherent, reports all pre-specified endpoints including null results, discusses limitations, and gives funding/COI.

Evidence

“ClinicalTrials.gov with the identifier NCT05043610”

Abstract

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

Methods ¶1

“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.”

Limitations

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: 35 verified — 1 lookup failed.

2 data/code links checked; 2 live.

Copyediting

1 finding · worst low

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

Wording or formatting errors that need correctingAssessed

12 copyedit issues flagged (5 major): mostly consistency, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

This is a published paper with significant reporting issues that warrant a correction. An informed reader should weigh the arithmetic inconsistencies in Table 2 (HF incidence rates) and the abstract/results HR discrepancy before relying on the reported effect sizes. The truncated data availability statement and the contradictory safety statement ('No adverse events were noticed') are additional concerns. An erratum or a letter to the editor addressing these issues would improve the record.

1.
HIGHstatistics
Correct the arithmetic error in Table 2 for the HF incidence rates: the reported rates (2.77% and 6.48%) do not match the calculation from events and person-years (9/314.47=2.86%, 37/551.88=6.70%). Clarify the person-years denominator used or correct the rates.
This is a demonstrable data-reporting error that undermines the reliability of the primary endpoint results.
2.
HIGHreporting
Harmonize the composite-endpoint hazard ratio between the abstract (0.39) and the results text (0.40) and ensure the corresponding P value and confidence interval are consistent.
Internal inconsistency in a key result can confuse readers and may indicate a calculation error.
3.
HIGHdata code
Complete the data availability statement with a concrete access route (e.g., de-identified participant data available on reasonable request with a named repository or a data-access committee).
The current truncated statement ('Data availability statement De-id') is insufficient for a published clinical trial and violates CONSORT reporting standards.
4.
HIGHreporting
Correct the safety statement 'No adverse events were noticed' to either qualify it as 'no intervention-related adverse events' or provide a full adverse-event table, as the trial reports deaths and heart failure events as endpoints.
The current statement is directly contradicted by the trial's own endpoint events, which is a serious reporting inconsistency.
5.
HIGHstatistics
Correct the impossible percentage values in Table 1 for the eGFR <60 row (134% and 1% are impossible; likely they should be 13% and 15%).
This is a clear typographical error that distorts the baseline characteristics table.
6.
HIGHreporting
Explicitly state the alpha level (e.g., α=0.05) and statistical power (e.g., 80%) used in the sample-size calculation in the Methods section.
These parameters are standard for reporting a power analysis and their absence is a minor reporting gap.
7.
HIGHrigor
Add the manufacturer/source, lot/batch number, and release criteria for the Wharton's jelly-derived MSCs in the Methods section, including a statement on mycoplasma testing.
The investigational product is a key resource; missing details limit reproducibility and the ability to assess product consistency.
8.
HIGHrigor
Provide flow-cytometry antibody details (clone, vendor, catalog number) for the cell surface markers used in product characterization.
Antibody clone and vendor information is essential for reproducibility of the product characterization.
9.
MEDIUMother
Add race/ethnicity (or a justification for its omission) to Table 1 for completeness of demographic reporting.
While not always mandatory, race/ethnicity is a standard demographic variable that may be relevant for generalizability.
10.
MEDIUMcopyedit
Fix the typo 'conduced' to 'conducted' in the Patient care section.
Minor typographical error that should be corrected.
11.
MEDIUMcopyedit
Add the missing closing parenthesis in Table 2 for the row '16.08 (10.90 to 21.27' to read '16.08 (10.90 to 21.27)'.
Missing parenthesis is a formatting error that could cause confusion.
12.
LOWother
Consider depositing de-identified participant-level data in a recognized repository and sharing the Stata analysis code (do-files) on a public repository (e.g., GitHub with a DOI) to enhance reproducibility.
This is a best practice for open science and would strengthen the paper's transparency.

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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.

Read full text (PMC)

Journal

DOI

10.1136/bmj-2024-083382

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Record fingerprint

607a284fa08b6c0c81888504456300b8db720c7b1c307b3d2354862c972024e8

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Issued Aug 5, 2026Engine 7.15.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

1.25 / 5

Critical — serious problems across many checks

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×5−2.5★
ClaimsUnsupported claim (uncorroborated)−0.5★
ReportingData & code availability not met−0.5★
ReportingStatistical analysis partially met−0.25★

Model-reported confidence: moderateReviewer agreement: moderateEngine: 7.15.0Source: full text

Biggest issues

01Conclusion not supported by the paper’s own evidence
highOverreachreviewer-assessedFull detail
No adverse events were noticed.
“No adverse events were noticed.”
Adverse events and safety
02Data and code not shared
highDisclosurereviewer-assessedFull detail
The data availability statement is incomplete (appears truncated), and no code is shared. For a clinical trial, a proper data availability statement is required.
“Data availability statement De-id”
References
03Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
The safety section states 'No adverse events were noticed' although the trial reports 16 deaths, 61 heart-failure events (9+37 incidence + 3+24 readmissions counted separately), and 22 MI readmissions across groups; unless qualified to procedure-related events, this is a direct contradiction.
“No adverse events were noticed.”
Adverse events and safety
04Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
In Table 2, HF-incidence rates do not match the event counts/person-years: 9/314.47 gives 2.86% (reported 2.77%) and 37/551.88 gives 6.70% (reported 6.48%). The reported rates correspond to the readmission-to-HF person-years (325.39 and 570.98).
“9/314.47 | 5.74 (1.99 to 9.50) | 2.77 (1.44 to 5.32) | 37/551.88 | 16.08 (10.90 to 21.27 | 6.48 (4.69 to 8.94)”
Table 2

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 203AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 106CopyeditCopyediting

Numerical inconsistencies

1 finding · worst medium

Internal contradictions in the reported numbersAssessed

Recomputed 14 tests: 14 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 12 via agent-written checks.

Overstated conclusions

2 findings · worst high

Conclusions not supported by the paper’s own evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

12 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

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

Data authenticity concerns

2 findings · worst low

Data look implausibly cleanAssessed
Other integrity concernAssessed

5 integrity concerns flagged (0 high).

Reporting gaps

2 findings · worst high

Data and code not sharedAssessed
Statistical reporting gaps (tests, assumptions, effect sizes)Assessed

Eight Dimensions6 pass · 1 warn · 1 fail

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

Introduction

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing prior research, providing a logical rationale, and addressing limitations of previous studies.

Evidence

Introduction ¶2

“Mesenchymal stem cells have shown greater promise than bone marrow derived mononuclear cells for treating patients with acute myocardial infarction.”

Introduction ¶3

paraphrase[Introduction, last paragraph]

PASSReviewer 3· 95% conf

Evidence

Introduction

“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”

Introduction

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

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”

Methods

“However, all researchers, clinicians, and staff members responsible for follow-up care, outcome adjudication, and data analysis remained blinded.”

Methods

PASSReviewer 2· 90% conf

The study design is adequately described with randomization, blinding, sample size calculation, and inclusion/exclusion criteria.

Evidence

Methods

“However, all researchers, clinicians, and staff members responsible for follow-up care, outcome adjudication, and data analysis remained blinded.”

Same section

PASSReviewer 3· 90% conf

Evidence

Methods

“However, all researchers, clinicians, and staff members responsible for follow-up care, outcome adjudication, and data analysis remained blinded.”

Methods

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported for a human trial: sex, age, BMI, and comprehensive medical history are given, and the cohort is mixed-sex.

Evidence

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

Results

“Mean (SD) age, years | 57.8 (10.7) | 59.2 (10.9) | 58.7 (10.8)”

Table 1

PASSReviewer 2· 95% conf

Sex, age, health status, and demographics are adequately reported in Table 1.

Evidence

paraphrase[Table 1]

“Male sex: 115 (85%) intervention, 205 (79%) control.”

paraphrase[Table 1]

“Mean (SD) age, years: 57.8 (10.7) intervention, 59.2 (10.9) control.”

paraphrase[Table 1]

“Table 1 includes smoking, BMI, medical history, and baseline health indicators.”

PASSReviewer 3· 80% conf

Sex, age, body-mass index, and extensive medical history are reported; race/ethnicity is not reported.

Evidence

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

Results

“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.”

Results

absence[Table 1 / baseline characteristics]

Race/ethnicity is not reported.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval with a protocol number, informed consent, and Declaration of Helsinki compliance are all explicitly stated.

Evidence

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

Ethics

“Informed consent was obtained from all patients.”

Ethics

PASSReviewer 2· 95% conf

Ethics approval, informed consent, and regulatory compliance are clearly stated.

Evidence

paraphrase[Ethics statements]

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

“All patients gave informed consent.”

Methods

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

Ethics

PASSReviewer 3· 85% conf

Ethical approval, informed consent, and Declaration of Helsinki compliance are reported with an approval code and trial registration.

Evidence

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

Ethics

“Informed consent was obtained from all patients.”

Ethics

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

Ethics

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational biologic (MSCs) is well characterized, and the statistical software is identified; the bench-style criteria are not applicable to this clinical trial.

Evidence

Methods

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

Statistical analysis

PASSReviewer 2· 90% conf

The investigational product (MSCs) is described in detail, and statistical software is identified.

Evidence

paraphrase[Methods, Intracoronary infusion of mesenchymal stem cells]

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

Statistical analysis

WARNReviewer 3· 70% conf

Evidence

Methods

“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”

Methods

absence[Methods, 'Intracoronary infusion of mesenchymal stem cells']

Mycoplasma testing is not reported.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationINADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityWARN

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

The statistical analysis is generally rigorous and well reported, but a demonstrable typographical error in Table 1 (impossible percentages for eGFR <60) lowers the overall rating.

Evidence

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

Abstract

“eGFR <60 mm/min/1.73 m 2 | 18 (134) | 39 (1) | 57 (14)”

Table 1

WARNReviewer 2· 80% conf

Evidence

paraphrase[Table 2]

paraphrase[Abstract, Results]

“P=0.024, P=0.015, P=0.012, etc.”

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

Results

WARNReviewer 3· 75% conf

Evidence

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

Statistical analysis

“9/314.47 | 5.74 (1.99 to 9.50) | 2.77 (1.44 to 5.32) | 37/551.88 | 16.08 (10.90 to 21.27 | 6.48 (4.69 to 8.94)”

Table 2

“0.39, 0.19 to 0.82; P=0.012”

Abstract

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 80% conf

A data availability statement is present but truncated/vague, and no repository deposit or code sharing is reported.

Evidence

“Data availability statement De-id”

Data availability

“An interactive version of this graphic and downloadable data are available at https://public.flourish.studio/visualisation/25452455/”

Results

FAILReviewer 2· 95% conf

The data availability statement is incomplete (appears truncated), and no code is shared. For a clinical trial, a proper data availability statement is required.

Evidence

“Data availability statement De-id”

References

WARNReviewer 3· 60% conf

A data availability statement begins but its full text is not visible in the provided excerpt; figure-level data are shared via Flourish URLs, but no repository/accession or code is identified.

Evidence

“Data availability statement De-id”

Data availability

“An interactive version of this graphic and downloadable data are available at https://public.flourish.studio/visualisation/25452455/”

Results

absence[Methods, 'Statistical analysis']

Custom analysis code is not shared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The manuscript is transparent: trial registration, CONSORT adherence, complete reporting of outcomes, limitations, and funding/COI statements are all present.

Evidence

“Trial registration ClinicalTrials.gov NCT05043610 .”

Abstract

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

Methods

“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.”

Limitations

PASSReviewer 2· 95% conf

The paper is well-reported with detailed methods, trial registration, CONSORT adherence, all outcomes reported, limitations discussed, proportional conclusions, and funding/COI statements.

Evidence

“Trial registration ClinicalTrials.gov NCT05043610 .”

Abstract

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

Methods

paraphrase[Discussion, Strengths and limitations]

“The limitations of this study include the inability to do a sham procedure for the control group...”

PASSReviewer 3· 90% conf

The manuscript is transparent: registered, CONSORT-adherent, reports all pre-specified endpoints including null results, discusses limitations, and gives funding/COI.

Evidence

“ClinicalTrials.gov with the identifier NCT05043610”

Abstract

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

Methods ¶1

“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.”

Limitations

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: 35 verified — 1 lookup failed.

2 data/code links checked; 2 live.

Copyediting

1 finding · worst low

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

Wording or formatting errors that need correctingAssessed

12 copyedit issues flagged (5 major): mostly consistency, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHstatistics
Correct the arithmetic error in Table 2 for the HF incidence rates: the reported rates (2.77% and 6.48%) do not match the calculation from events and person-years (9/314.47=2.86%, 37/551.88=6.70%). Clarify the person-years denominator used or correct the rates.
This is a demonstrable data-reporting error that undermines the reliability of the primary endpoint results.
2.
HIGHreporting
Harmonize the composite-endpoint hazard ratio between the abstract (0.39) and the results text (0.40) and ensure the corresponding P value and confidence interval are consistent.
Internal inconsistency in a key result can confuse readers and may indicate a calculation error.
3.
HIGHdata code
Complete the data availability statement with a concrete access route (e.g., de-identified participant data available on reasonable request with a named repository or a data-access committee).
The current truncated statement ('Data availability statement De-id') is insufficient for a published clinical trial and violates CONSORT reporting standards.
4.
HIGHreporting
Correct the safety statement 'No adverse events were noticed' to either qualify it as 'no intervention-related adverse events' or provide a full adverse-event table, as the trial reports deaths and heart failure events as endpoints.
The current statement is directly contradicted by the trial's own endpoint events, which is a serious reporting inconsistency.
5.
HIGHstatistics
Correct the impossible percentage values in Table 1 for the eGFR <60 row (134% and 1% are impossible; likely they should be 13% and 15%).
This is a clear typographical error that distorts the baseline characteristics table.
6.
HIGHreporting
Explicitly state the alpha level (e.g., α=0.05) and statistical power (e.g., 80%) used in the sample-size calculation in the Methods section.
These parameters are standard for reporting a power analysis and their absence is a minor reporting gap.
7.
HIGHrigor
Add the manufacturer/source, lot/batch number, and release criteria for the Wharton's jelly-derived MSCs in the Methods section, including a statement on mycoplasma testing.
The investigational product is a key resource; missing details limit reproducibility and the ability to assess product consistency.
8.
HIGHrigor
Provide flow-cytometry antibody details (clone, vendor, catalog number) for the cell surface markers used in product characterization.
Antibody clone and vendor information is essential for reproducibility of the product characterization.
9.
MEDIUMother
Add race/ethnicity (or a justification for its omission) to Table 1 for completeness of demographic reporting.
While not always mandatory, race/ethnicity is a standard demographic variable that may be relevant for generalizability.
10.
MEDIUMcopyedit
Fix the typo 'conduced' to 'conducted' in the Patient care section.
Minor typographical error that should be corrected.
11.
MEDIUMcopyedit
Add the missing closing parenthesis in Table 2 for the row '16.08 (10.90 to 21.27' to read '16.08 (10.90 to 21.27)'.
Missing parenthesis is a formatting error that could cause confusion.
12.
LOWother
Consider depositing de-identified participant-level data in a recognized repository and sharing the Stata analysis code (do-files) on a public repository (e.g., GitHub with a DOI) to enhance reproducibility.
This is a best practice for open science and would strengthen the paper's transparency.

Full text (58,902 chars)Analyzed: Aug 5, 2026