Tissue-engineered products (TEPs) are at the forefront of developmental medicines, precisely where monoclonal antibodies and recombinant cytokines were 30 years ago. TEPs development for treating skin wounds has become a fast-growing field as it offers the potential to find novel therapeutic approaches for treating pathologies that currently have limited or no effective alternatives. This review aims to provide the reader with the process of translating an idea from the laboratory bench to clinical practice, specifically in the context of TEPs designing for skin wound healing. It encompasses historical perspectives, approved therapies, and offers a distinctive insight into the regulatory framework in Brazil. We explore the essential guidelines for quality testing, and nonclinical proof-of-concept considering the Brazilian Network of Experts in Advanced Therapies (RENETA) and International Standards and Guidelines (ICH e ISO). Adopting a multifaceted approach, our discussion incorporates scientific and industrial perspectives, addressing quality, biosafety, non-clinical viability, clinical trial and real-word data for pharmacovigilance demands. This comprehensive analysis presents a panoramic view of the development of skin TEPs, offering insights into the evolving landscape of this dynamic and promising field.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.ijpharm.2024.124319 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Insights on the role of cryoprotectants in enhancing the properties of bioinks required for cryobioprinting of biological constructs.
J Mater Sci Mater Med
January 2025
Tissue Engineering & Additive Manufacturing (TEAM) Lab, Centre for Nanotechnology & Advanced Biomaterials (CeNTAB), ABCDE Innovation Centre, School of Chemical & Biotechnology (SCBT), SASTRA Deemed University, Thanjavur, 613401, India.
Preservation and long-term storage of readily available cell-laden tissue-engineered products are major challenges in expanding their applications in healthcare. In recent years, there has been increasing interest in the development of off-the-shelf tissue-engineered products using the cryobioprinting approach. Here, bioinks are incorporated with cryoprotective agents (CPAs) to allow the fabrication of cryopreservable tissue constructs.
View Article and Find Full Text PDFConsiderations for manufacturing of cell and gene medicines for clinical development.
Cytotherapy
December 2024
Cancer Institute, University College London, London, UK. Electronic address:
The global changes from 2001 that elevated substantially modified cell therapies to the definition of "medicinal product" have been the catalyst for the dramatic expansion of the field to its current and future commercial success. Europe was the first to incorporate human somatic cells into drug legislation with the medicines directive of 2001 (2001/83/EC), which led to the development of the term "advanced therapy medicinal products" (ATMPs) to cover all substantially modified products, tissue-engineered products and somatic cells that are not substantially modified but that are used non-homologously. For convenience, I use the term "ATMPs" throughout this review.
View Article and Find Full Text PDFMultifunctional electrospinning periosteum: Development status and prospect.
J Biomater Appl
January 2025
State Key Laboratory of New Textile Materials and Advanced Processing Technologies, Wuhan Textile University, Wuhan, China.
In the repair of large bone defects, loss of the periosteum can result in diminished osteoinductive activity, nonunion, and incomplete regeneration of the bone structure, ultimately compromising the efficiency of bone regeneration. Therefore, the research and development of tissue-engineered periosteum which can replace the periosteum function has become the focus of current research. The functionalized electrospinning periosteum is expected to mimic the natural periosteum and enhance bone repair processes more effectively.
View Article and Find Full Text PDFsiRNA Treatment Enhances Collagen Fiber Formation in Tissue-Engineered Meniscus via Transient Inhibition of Aggrecan Production.
Bioengineering (Basel)
December 2024
Meinig of Biomedical Engineering, Cornell University, Ithaca, NY 14853, USA.
The complex collagen network of the native meniscus and the gradient of the density and alignment of this network through the meniscal enthesis is essential for the proper mechanical function of these tissues. This architecture is difficult to recapitulate in tissue-engineered replacement strategies. Prenatally, the organization of the collagen fiber network is established and aggrecan content is minimal.
View Article and Find Full Text PDFSpatial Transcriptomics, Proteomics, and Epigenomics as Tools in Tissue Engineering and Regenerative Medicine.
Bioengineering (Basel)
December 2024
Department of Odontology, Umeå University, 90187 Umeå, Sweden.
Spatial transcriptomics, proteomics, and epigenomics are innovative technologies which offer an unparalleled resolution and wealth of data in understanding and the interpretation of cellular functions and interactions. These techniques allow researchers to investigate gene and protein expressions at an individual cell level, revealing cellular heterogeneity within, for instance, bioengineered tissues and classifying novel and rare cell populations that could be essential for the function of the tissues and in disease processes. It is possible to analyze thousands of cells simultaneously, which gives thorough insights into the transcriptomic view of complex tissues.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!