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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)

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

DOI: 10.1136/bmj-2024-083382
Record issued: 2026-08-05
Engine: 7.15.0
Exported: 2026-09-20

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/117ba327-8f47-4b7d-a1f4-b897c4bae1b2 is authoritative.

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.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p = .024 · recomputed p = .022
Recomputed hazard ratio 0.43 (95% CI 0.21–0.89), reported p=0.024
How we recomputed it: pCI(0.43, 0.21, 0.89, 1)
CONSISTENTreported p = .002 · recomputed p = .002
Recomputed relative risk 0.643 (95% CI 0.489–0.845), reported p=0.002
How we recomputed it: pCI(0.643, 0.489, 0.845, 1)
CONSISTENTreported p = .015 · recomputed p = .018Reviewers 1, 3
Readmission for HF HR 0.22 (95% CI 0.06-0.74), reported P=0.015
How we recomputed it: pCI(0.22, 0.06, 0.74, 1)
CONSISTENTreported p = .012 · recomputed p = .012Reviewers 1, 3
Composite endpoint HR 0.39 (95% CI 0.19-0.82) from abstract, reported P=0.012
How we recomputed it: pCI(0.39, 0.19, 0.82, 1)
CONSISTENTreported p = .012 · recomputed p = .014Reviewer 1
Composite endpoint HR 0.40 (95% CI 0.19-0.82) from results, reported P=0.012
How we recomputed it: pCI(0.40, 0.19, 0.82, 1)
CONSISTENTreported p = .100 · recomputed p = .093Reviewers 1, 3
Readmission for MI HR 0.40 (95% CI 0.14-1.19), reported P=0.10
How we recomputed it: pCI(0.40, 0.14, 1.19, 1)
CONSISTENTreported p = .860 · recomputed p = .853Reviewer 1
All-cause mortality HR 1.10 (95% CI 0.40-3.02), reported P=0.86
How we recomputed it: pCI(1.10, 0.40, 3.02, 1)
CONSISTENTreported p = .570 · recomputed p = .570Reviewers 1, 3
Cardiovascular mortality HR 0.68 (95% CI 0.18-2.57), reported P=0.57
How we recomputed it: pCI(0.68, 0.18, 2.57, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1
LVEF change beta=5.88 (95% CI 4.00-7.76), reported P<0.001
How we recomputed it: pCI(5.88, 4.00, 7.76, 0)
CONSISTENTreported p = .015 · recomputed p = .018Reviewer 2
Secondary endpoint: HR for readmission to hospital for heart failure
How we recomputed it: pCI(0.22, 0.06, 0.74, 1)
CONSISTENTreported p = .012 · recomputed p = .012Reviewer 2
Composite endpoint: HR for cardiovascular mortality and readmission for HF or MI
How we recomputed it: pCI(0.39, 0.19, 0.82, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
LVEF change: linear regression coefficient
How we recomputed it: pCI(5.88, 4.00, 7.76, 0)
CONSISTENTreported p = .860 · recomputed p = .853Reviewer 3
All cause mortality HR 1.10 (95% CI 0.40 to 3.02), reported P=0.86
How we recomputed it: pCI(1.10, 0.40, 3.02, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 3
LVEF change β=5.88 (95% CI 4.00 to 7.76), reported P<0.001
How we recomputed it: pCI(5.88, 4.00, 7.76, 0)

mediuminternal contradiction
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
mediuminternal contradiction
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
lowinternal contradiction
The composite-endpoint hazard ratio is reported as 0.39 in the abstract and 0.40 in the results text for the same crude Cox analysis.
“crude hazard ratio 0.40, 0.19 to 0.82”
Abstract

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).

unsupportedReviewer 3
No adverse events were noticed.
The claim is contradicted by the trial's own endpoint events, including deaths and heart failure events, and no adverse-event table is provided.
Evidence: The paper reports 16 deaths, 46 heart-failure events, and 22 MI readmissions across groups in Table 2, yet the safety section states 'No adverse events were noticed.'
“No adverse events were noticed.”
Adverse events and safety
partialReviewer 1
This technique may serve as a valuable adjunctive procedure after myocardial infarction to prevent heart failure and reduce adverse events.
The positive results on heart failure and composite endpoints support the claim, but the lack of mortality benefit and the single-blind design temper the strength of the conclusion.
Evidence: Primary and secondary endpoint results as above; limitations acknowledged in discussion.
“suggesting that this technique may serve as a valuable adjunctive procedure after myocardial infarction to prevent the development of heart failure and reduce the risk of future adverse events.”
Conclusion
supportedReviewer 1
Intracoronary infusion of Wharton's jelly derived mesenchymal stem cells significantly reduced the risk of incidence of heart failure.
The reported HR 0.43 (95% CI 0.21-0.89, P=0.024) directly supports this claim.
Evidence: Primary endpoint analysis: HR 0.43, 95% CI 0.21-0.89, P=0.024.
“Intracoronary infusion of mesenchymal stem cells had a preventive effect for incidence of heart failure (2.77 v 6.48 per 100 person years; hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024)”
Abstract
supportedReviewers 1, 3
Intracoronary infusion reduced readmission to hospital for heart failure.
The reported HR 0.22 (95% CI 0.06-0.74, P=0.015) supports this claim.
Evidence: Secondary endpoint analysis: HR 0.22, 95% CI 0.06-0.74, P=0.015.
“readmission to hospital for heart failure (0.92 v 4.20 per 100 person years; 0.22, 0.06 to 0.74; P=0.015)”
Abstract
supportedReviewers 1, 2
Intracoronary infusion reduced the composite endpoint of cardiovascular mortality and readmission for myocardial infarction or heart failure.
The reported HR 0.39/0.40 (95% CI 0.19-0.82, P=0.012) supports this claim, though the slight discrepancy in the HR value between abstract and results is noted.
Evidence: Composite endpoint analysis: HR 0.39-0.40, 95% CI 0.19-0.82, P=0.012.
“a composite endpoint of cardiovascular mortality and readmission for myocardial infarction or heart failure (2.80 v 7.16 per 100 person years; 0.39, 0.19 to 0.82; P=0.012)”
Abstract
supportedReviewer 1
Left ventricular ejection fraction improved significantly more in the intervention group at six months.
The linear regression beta of 5.88 (95% CI 4.00-7.76, P<0.001) supports this claim.
Evidence: Changes in LVEF: beta=5.88, 95% CI 4.00-7.76, P<0.001.
“Linear regression analysis confirmed that treatment allocation was a significant predictor of change in left ventricular ejection fraction, with the intervention group showing a mean increase of approximately six percentage points compared with the control group (β=5.88%, 95% CI 4.00% to 7.76%; P<0.001).”
Results
supportedReviewer 1
The intervention did not significantly affect readmission for myocardial infarction, all-cause mortality, or cardiovascular mortality.
All three reported HRs have CIs spanning 1 and non-significant p-values, supporting the claim of no statistically significant effect.
Evidence: Readmission MI HR 0.40 (0.14-1.19, P=0.10); all-cause mortality HR 1.10 (0.40-3.02, P=0.86); cardiovascular mortality HR 0.68 (0.18-2.57, P=0.57).
“The intervention did not have a statistically significant effect on readmission to hospital for myocardial infarction (1.23 v 3.06 per 100 person years; hazard ratio 0.40, 0.14 to 1.19; P=0.10), all cause mortality (1.81 v 1.66 per 100 person years; 1.10, 0.40 to 3.02; P=0.86), or cardiovascular mortality (0.91 v 1.33 per 100 person years; 0.68, 0.18 to 2.57; P=0.57).”
Abstract
supportedReviewer 2
Intracoronary infusion of mesenchymal stem cells had a preventive effect for incidence of heart failure
The paper presents a significant hazard ratio (0.43, 95% CI 0.21 to 0.89, P=0.024) from Cox regression and Kaplan-Meier analysis, supporting the claim.
Evidence: Abstract, Results, Table 2, Figure 2
“Intracoronary infusion of mesenchymal stem cells had a preventive effect for incidence of heart failure (2.77 v 6.48 per 100 person years; hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024)”
Abstract
supportedReviewer 2
Reduction in readmission to hospital for heart failure
The paper reports a significant hazard ratio (0.22, 95% CI 0.06 to 0.74, P=0.015) supporting this claim.
Evidence: Abstract, Results, Table 2
“readmission to hospital for heart failure (0.92 v 4.20 per 100 person years; 0.22, 0.06 to 0.74; P=0.015)”
Abstract
supportedReviewer 2
No significant effect on readmission for myocardial infarction, all cause mortality, or cardiovascular mortality
The paper reports non-significant p-values (0.10, 0.86, 0.57) for these endpoints, supporting the claim.
Evidence: Abstract, Results
“The intervention did not have a statistically significant effect on readmission to hospital for myocardial infarction (1.23 v 3.06 per 100 person years; hazard ratio 0.40, 0.14 to 1.19; P=0.10), all cause mortality (1.81 v 1.66 per 100 person years; 1.10, 0.40 to 3.02; P=0.86), or cardiovascular mortality (0.91 v 1.33 per 100 person years; 0.68, 0.18 to 2.57; P=0.57)”
Abstract
supportedReviewers 2, 3
Significantly greater improvement in left ventricular ejection fraction at six months in the intervention group
The paper reports a significant linear regression coefficient (β=5.88, 95% CI 4.00 to 7.76, P<0.001) supporting this claim.
Evidence: Results, Figure 4
“Left ventricular ejection fraction in the intervention group showed a significantly greater improvement from baseline at six months compared with the control group (β=5.88, 95% confidence interval 4.00 to 7.76; P<0.001)”
Abstract
supportedReviewer 3
Intracoronary infusion of WJ-MSCs reduced the incidence of heart failure.
The presented HR, CI, and P value from the primary endpoint analysis directly support a significant reduction.
Evidence: Primary endpoint: HR 0.43, 95% CI 0.21 to 0.89, P=0.024; log-rank P=0.020 for KM analysis.
“Intracoronary infusion of mesenchymal stem cells had a preventive effect for incidence of heart failure (2.77 v 6.48 per 100 person years; hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024)”
Abstract

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

ADEQUATESurrogate endpoint
Primary endpoint is incidence of heart failure, a clinical hard outcome.
“The primary endpoint was the incidence of heart failure, defined as a clinical condition with symptoms of dyspnoea at rest or during exertion and evidence of cardiogenic pulmonary or systemic congestion necessitating an outpatient visit, hospital admission, or emergency department visit during which medical therapy was administered for symptoms and signs consistent with cardiac decompensation or impaired cardiac function.”
ADEQUATEEffect size
Hazard ratio for heart failure incidence is 0.43 (95% CI 0.21 to 0.89), representing a 57% reduction; absolute rates 2.77 vs 6.48 per 100 person-years. This is a clinically material reduction in a hard clinical endpoint.
“Intracoronary infusion of mesenchymal stem cells had a preventive effect for incidence of heart failure (2.77 v 6.48 per 100 person years; hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024)”

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).

lowother
The reported annual incidence rates for heart failure in Table 2 do not match the simple calculation from events and person-years: intervention 9/314.47=2.86% vs reported 2.77%; control 37/551.88=6.70% vs reported 6.48%.
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).
Table 2reviewer’s wording
lowdata too clean
Table 1 contains an impossible percentage ('134%') for eGFR <60 in the intervention group, indicating a typographical error rather than an integrity issue.
“eGFR <60 mm/min/1.73 m 2 | 18 (134) | 39 (1) | 57 (14)”
Table 1

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.

ClinicalTrials.gov

NCT05043610

Reporting guidelines: 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.

NOT CHECKED10.1016/s0140-6736(04)16626-9
Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial
[crossref] rate_limited 429 https://api.crossref.org/works/10.1016%2Fs0140-6736(04)16626-9?mailto=editorial%40alpha1science.com: HTTP 429

2 data/code links checked; 2 live.

datahttps://public.flourish.studio/visualisation/25452455/LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://public.flourish.studio/visualisation/25427034/LIVEHTTP 200
Resolves, but the content could not be matched to the paper.

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.

MAJORtypoTable 1
“eGFR <60 mm/min/1.73 m 2 | 18 (134) | 39 (1) | 57 (14)”
→ Correct the percentages for the eGFR <60 row to plausible values (likely 13% and 15%).
The percentage 134% is impossible and 1% is inconsistent with the group sizes.
MAJORclarityEnd of paper before references
“Data availability statement De-id”
→ Replace with a complete statement, e.g., 'De-identified participant data may be available on reasonable request to the corresponding author after approval by the institutional review board.'
The current statement is truncated and does not convey any information.
MAJORconsistencyAdverse events and safety
“No adverse events were noticed.”
→ Clarify that this refers to no adverse events related to the study intervention/procedure, or provide a full adverse-event table; deaths and HF events were recorded as endpoints.
The sentence contradicts the endpoint events reported elsewhere in the paper.
MAJORconsistencyTable 2
“9/314.47 | 5.74 (1.99 to 9.50) | 2.77 (1.44 to 5.32)”
→ Correct the person-years or the incidence rate so the rate equals 9/denominator × 100 (e.g., 9/325.39 = 2.77).
The reported rate uses the readmission-to-HF person-years denominator.
MAJORconsistencyAbstract vs Results (endpoint analysis)
“0.39, 0.19 to 0.82; P=0.012”
→ Use one consistent HR for the composite endpoint (0.39 or 0.40) and align the P value.
Abstract reports 0.39; results text reports crude hazard ratio 0.40.
MINORconsistencyAbstract vs Results
“composite endpoint ... 0.39, 0.19 to 0.82; P=0.012”
→ Ensure the hazard ratio for the composite endpoint is consistent between the abstract (0.39) and the results (0.40).
The abstract reports 0.39 while the results section reports 0.40 for the same endpoint.
MINORclarityData availability statement
“Data availability statement De-id”
→ Complete the data availability statement with a full description of access conditions.
The statement is truncated in the provided text.
MINORconsistencyTable 1, row 'eGFR <60 mm/min/1.73 m 2'
“18 (134)”
→ Should likely be '18 (13)' to match the pattern of other entries.
The value '134' is likely a formatting error; the total n for intervention is 136, so 18 (13%) is plausible.
MINORconsistencyTable 2, person-years for readmission for HF and MI in intervention group
“325.39 vs 325.34”
→ Consider aligning the person-years more precisely or explaining the difference.
The slight difference is likely due to rounding, but it may confuse readers.
MINORtypoPatient care
“electrocardiography were conduced”
→ Change 'conduced' to 'conducted'.
Typographical error.
MINORpunctuationTable 2
“16.08 (10.90 to 21.27 |”
→ Add closing parenthesis: '16.08 (10.90 to 21.27)'.
Missing parenthesis in multiple rows of the table.
MINORotherTable 1
“18 (134) | 39 (1) | 57 (14)”
→ Verify the percentages; likely '18 (13)' and '39 (15)'.
OCR/formatting error in the eGFR <60 row.

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.

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

RigorReviewer 1

RigorReviewer 2

RigorReviewer 3

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

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.

DOI

10.1136/bmj-2024-083382

Record issued

2026-08-05

Engine

7.15.0

Exported

2026-09-20