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Past Trends and Future Directions of Cardiac Regenerative Medicine - A Systematic Analysis of Clinical Trial
Maaike Wulfse1, Mats T Vervoorn1, Jantijn J G J Amelink1
1Department of Cardiothoracic Surgery, Division of Heart & Lungs, University Medical Center Utrecht, P.O. Box 85500, Utrecht, 3508, GA, The Netherlands.
Abstract:
Cell therapy, gene therapy, and tissue engineering have been explored as potential strategies to repair or regenerate damaged cardiac tissue. Despite the presence of encouraging preclinical data, clinical trials of regenerative cardiac therapies have yielded mixed results. Our study aimed to investigate the fate of all registered clinical trials within regenerative cardiac medicine, with the purpose of exploring the potential role of publication bias (or trial-completion bias), how published and unpublished research affects the field, and to draw lessons and recommendations for future clinical trials. In this analysis, we show that only a third of all registered trials has yielded results and that a significant number of trials are not completed. Furthermore, we identified significant heterogeneity in study design, study phase, funding, specific therapies used, primary outcome measures and methods of outcome assessment. These observations might hinder the successful translation of cardiac regenerative therapies into clinical practice.
Insights
Regenerative cardiac medicine clinical trials show poor completion rates, with only one-third reporting results. This highlights issues like publication bias and heterogeneity, hindering progress in cardiac repair therapies.
Area of Science:
- Cardiovascular research
- Regenerative medicine
- Clinical trial analysis
Background:
- Cell therapy, gene therapy, and tissue engineering are investigated for cardiac repair.
- Preclinical data is promising, but clinical trials for regenerative cardiac therapies show mixed outcomes.
Purpose of the Study:
- To analyze the outcomes of registered clinical trials in regenerative cardiac medicine.
- To explore publication bias, the impact of unpublished research, and derive recommendations for future trials.
Main Methods:
- Systematic analysis of registered clinical trials in regenerative cardiac medicine.
- Assessment of trial completion rates, publication status, and study design characteristics.
Main Results:
- Only one-third of registered trials have reported results; a significant number are incomplete.
- Substantial heterogeneity exists in trial design, phase, funding, therapies, and outcome measures.
- Publication bias and trial completion bias may be influencing the field's perceived success.
Conclusions:
- The high rate of incomplete trials and heterogeneity in regenerative cardiac medicine pose significant challenges.
- Addressing publication bias and standardizing trial methodologies are crucial for successful clinical translation.
- Lessons learned can guide more effective future clinical trials in cardiac regeneration.
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