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Global trends in clinical trials involving engineered biomaterials.

ABSTRACT: Engineered biomaterials are materials specifically designed to interact with biological systems for biomedical applications. This paper offers the comprehensive analysis of global clinical trial trends involving such materials. We surveyed 834 studies in the ClinicalTrials.gov database and explored biomaterial types, their initiation points, and durations in clinical trials. Predominantly, synthetic and natural polymers, particularly silicone and collagen, are used. Trials, focusing on ophthalmology, dentistry, and vascular medicine, are primarily conducted in the United States, Canada, and Italy. These trials encompass a broad demographic, and trials enrolled fewer than 100 participants. The study duration varied ranging from 0.5 to 4.5 years. These biomaterials are mainly bioresorbable or bioinert, with the integration of cells in biomaterials remaining an underexplored area. Our findings shed light on current practices and future potentials of engineered biomaterials in clinical research, offering insights for advancing this dynamic field globally.

SUBMITTER: Lele M

PROVIDER: S-EPMC466960 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

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Global trends in clinical trials involving engineered biomaterials.

Lele Mahima M Kapur Shaunak S Hargett Sarah S Sureshbabu Nivedhitha Malli NM Gaharwar Akhilesh K AK

Science advances 20240717 29

Engineered biomaterials are materials specifically designed to interact with biological systems for biomedical applications. This paper offers the comprehensive analysis of global clinical trial trends involving such materials. We surveyed 834 studies in the ClinicalTrials.gov database and explored biomaterial types, their initiation points, and durations in clinical trials. Predominantly, synthetic and natural polymers, particularly silicone and collagen, are used. Trials, focusing on ophthalmo ...[more]

PMID: 39018412

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Project description:Pluripotent stem cells (PSCs) hold great potential for novel therapeutic approaches to regenerate or replace functionally impaired tissues. Since the introduction of the induced pluripotent stem cell technology in 2006, the number of scientific publications on this topic has constantly been increasing. However, so far no therapy based on PSCs has found its way into routine clinical use. In this study, we examined research trends related to clinical trials involving PSCs based on data obtained from ClinicalTrials.gov, the ICTRP database from the World Health Organization, as well as from a search of all individual databases that are included in the ICTRP using a multistep search algorithm. Following a stringent inclusion/exclusion procedure 131 studies remained that could be classified as clinical trials involving PSCs. The magnitude of these studies (77.1%) was observational, which implies that no cells were transplanted into patients, and only a minority of studies (22.9%) were of an interventional study type. The number of clinical trials involving induced pluripotent stem cells (iPSCs, 74.8%) was substantially higher than the one involving embryonic stem cells (ESCs, 25.2%). However, the picture changes completely when focusing on interventional studies, where in the majority (73.3%) of cases ESCs were used. Interestingly, also the study duration was significantly shorter for interventional versus observational trials (p = 0.002). When focusing on the geographical study regions, it became obvious that the greatest part of all observational trials was performed in the USA (41.6%) and in France (16.8%), while the magnitude of interventional studies was performed in Asian countries (China 36.7%, Japan 13.3%, South Korea 10.0%) and in the field of ophthalmology. In summary, these results indicate that only a limited number of trials were focusing on the actual transplantation of PSCs into patients in a rather narrow field of diagnoses. The future will tell us, if the iPSC technology will ultimately overcome the current challenges and will finally make its way into routine clinical use.

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Global trends in clinical trials involving engineered biomaterials.

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Global trends in clinical trials involving engineered biomaterials.

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