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      Global trends in clinical trials involving engineered biomaterials

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          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.

          Abstract

          A comprehensive analysis of global clinical trial trends in engineered biomaterials is explored, surveying 834 studies.

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          CAR-T cell therapy: current limitations and potential strategies

          Robert C. Sterner, Rosalie M. Sterner (2021)
          Chimeric antigen receptor (CAR)-T cell therapy is a revolutionary new pillar in cancer treatment. Although treatment with CAR-T cells has produced remarkable clinical responses with certain subsets of B cell leukemia or lymphoma, many challenges limit the therapeutic efficacy of CAR-T cells in solid tumors and hematological malignancies. Barriers to effective CAR-T cell therapy include severe life-threatening toxicities, modest anti-tumor activity, antigen escape, restricted trafficking, and limited tumor infiltration. In addition, the host and tumor microenvironment interactions with CAR-T cells critically alter CAR-T cell function. Furthermore, a complex workforce is required to develop and implement these treatments. In order to overcome these significant challenges, innovative strategies and approaches to engineer more powerful CAR-T cells with improved anti-tumor activity and decreased toxicity are necessary. In this review, we discuss recent innovations in CAR-T cell engineering to improve clinical efficacy in both hematological malignancy and solid tumors and strategies to overcome limitations of CAR-T cell therapy in both hematological malignancy and solid tumors.
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            The stiffness of living tissues and its implications for tissue engineering

            Carlos F. C. R. Guimarães, Luca Gasperini, Alexandra P. Marques … (2020)
            Article 0 comments Cited 373 times – based on 0 reviews     Review now
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              Clinical Trials With Mesenchymal Stem Cells: An Update.

              Tiziana Squillaro, Gianfranco Peluso, Umberto Galderisi (2016)
              In the last year, the promising features of mesenchymal stem cells (MSCs), including their regenerative properties and ability to differentiate into diverse cell lineages, have generated great interest among researchers whose work has offered intriguing perspectives on cell-based therapies for various diseases. Currently the most commonly used adult stem cells in regenerative medicine, MSCs, can be isolated from several tissues, exhibit a strong capacity for replication in vitro, and can differentiate into osteoblasts, chondrocytes, and adipocytes. However, heterogeneous procedures for isolating and cultivating MSCs among laboratories have prompted the International Society for Cellular Therapy (ISCT) to issue criteria for identifying unique populations of these cells. Consequently, the isolation of MSCs according to ISCT criteria has produced heterogeneous, nonclonal cultures of stromal cells containing stem cells with different multipotent properties, committed progenitors, and differentiated cells. Though the nature and functions of MSCs remain unclear, nonclonal stromal cultures obtained from bone marrow and other tissues currently serve as sources of putative MSCs for therapeutic purposes, and several findings underscore their effectiveness in treating different diseases. To date, 493 MSC-based clinical trials, either complete or ongoing, appear in the database of the US National Institutes of Health. In the present article, we provide a comprehensive review of MSC-based clinical trials conducted worldwide that scrutinizes biological properties of MSCs, elucidates recent clinical findings and clinical trial phases of investigation, highlights therapeutic effects of MSCs, and identifies principal criticisms of the use of these cells. In particular, we analyze clinical trials using MSCs for representative diseases, including hematological disease, graft-versus-host disease, organ transplantation, diabetes, inflammatory diseases, and diseases in the liver, kidney, and lung, as well as cardiovascular, bone and cartilage, neurological, and autoimmune diseases.
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                Author and article information

                Contributors
                Mahim Lele:
                ORCID: https://orcid.org/0009-0003-1468-6074
                Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ValidationRole: Visualization
                Shaunak Kapur:
                ORCID: https://orcid.org/0009-0007-8053-8167
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing - original draftRole: Writing - review & editing
                Sarah Hargett:
                ORCID: https://orcid.org/0000-0002-5389-6344
                Role: VisualizationRole: Writing - original draftRole: Writing - review & editing
                Nivedhitha Malli Sureshbabu:
                ORCID: https://orcid.org/0000-0001-8979-6719
                Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: ValidationRole: VisualizationRole: Writing - original draftRole: Writing - review & editing
                Akhilesh K. Gaharwar:
                ORCID: https://orcid.org/0000-0002-0284-0201
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing - original draftRole: Writing - review & editing
                Journal
                Journal ID (nlm-ta): Sci Adv
                Journal ID (iso-abbrev): Sci Adv
                Journal ID (publisher-id): sciadv
                Journal ID (hwp): advances
                Title: Science Advances
                Publisher: American Association for the Advancement of Science
                ISSN (Electronic): 2375-2548
                Publication date Collection: 19 July 2024
                Publication date (Electronic, pub): 17 July 2024
                Volume: 10
                Issue: 29
                Electronic Location Identifier: eabq0997
                Affiliations
                [ 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.
                Author notes
                [* ]Corresponding author. Email: gaharwar@ 123456tamu.edu (A.K.G.); drmalli_nived@ 123456tamu.edu (N.M.S.)
                Author information
                https://orcid.org/0009-0003-1468-6074
                https://orcid.org/0009-0007-8053-8167
                https://orcid.org/0000-0002-5389-6344
                https://orcid.org/0000-0001-8979-6719
                https://orcid.org/0000-0002-0284-0201
                Article
                Publisher ID: abq0997
                DOI: 10.1126/sciadv.abq0997
                PMC ID: 466960
                PubMed ID: 39018412
                SO-VID: 77a5add6-e259-4321-8381-7535ebcc267e
                Copyright © Copyright © 2024 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works. Distributed under a Creative Commons Attribution NonCommercial License 4.0 (CC BY-NC).
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial license, which permits use, distribution, and reproduction in any medium, so long as the resultant use is not for commercial advantage and provided the original work is properly cited.

                History
                Date received : 17 January 2024
                Date accepted : 11 June 2024
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000002, National Institutes of Health;
                Award ID: R21 NS121945
                Funded by: FundRef http://dx.doi.org/10.13039/100000005, U.S. Department of Defense;
                Award ID: W81XWH2210932
                Funded by: FundRef http://dx.doi.org/10.13039/100000070, National Institute of Biomedical Imaging and Bioengineering;
                Award ID: DP2 EB026265
                Funded by: FundRef http://dx.doi.org/10.13039/100000072, National Institute of Dental and Craniofacial Research;
                Award ID: R01 DE032031
                Funded by: FundRef http://dx.doi.org/10.13039/100000968, American Heart Association;
                Award ID: 24PRE1200460
                Categories
                Subject: Review
                Subject: Biomedicine and Life Sciences
                Subject: SciAdv reviews
                Subject: Engineering
                Subject: Health and Medicine
                Subject: Applied Sciences and Engineering
                Custom metadata
                Copyeditor Vivian Hernandez

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