Global trends in clinical trials involving engineered biomaterials

Author:

Lele Mahim1ORCID,Kapur Shaunak2ORCID,Hargett Sarah3ORCID,Sureshbabu Nivedhitha Malli3ORCID,Gaharwar Akhilesh K.3456ORCID

Affiliation:

1. Bridgeland High School, 10707 Mason Rd., Cypress, TX 77433, USA.

2. Seven Lakes High School, 9251 S Fry Rd., Katy, TX 77494, USA.

3. Department of Biomedical Engineering, College of Engineering, Texas A&M University, College Station, TX 77843, USA.

4. Interdisciplinary Program in Genetics, Texas A&M University, College Station, TX 77843, USA.

5. Center for Remote Health Technologies and Systems, Texas A&M University, College Station, TX 77843, USA.

6. Department of Material Science and Engineering, College of Engineering, Texas A&M University, College Station, TX 77843, USA.

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.

Publisher

American Association for the Advancement of Science (AAAS)

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