About this Research Topic
Although MSC research discoveries brought new information, the road for cell therapy approval is still at its dawn. Due to the insurgence of MSC therapies, federal agencies with regulatory oversight to healthcare (Food and Drug Administration, European Medical Agency, Pharmaceuticals and Medical Devices Agency, Federal Service for Surveillance in Healthcare, etc.) have adapted and continue to update their guidelines as needed. Similarly, cell therapy manufacturers need to move quickly to establish and adopt best practices that ensure safety, quality and reproducibility of the cell therapy product. Since then, many questions have surfaced around preclinical tests, scalability of MSC production and clinical application, the need for development of chemically defined culture media and GMP compliant animal component free ancillary materials, and the development of 3D structures mimicking the tissue organization.
This Research Topic will host Original Research articles, Systematic Review, Mini Review, Methods, Technology and Code from leading scientists and clinicians around the world who are studying and developing MSC-based therapy. Topics of interest should apply to therapeutic applications of MSCs and include but are not limited to: Cell Therapy, Ex Vivo Gene Therapy, Process Development Challenges, GMP Manufacturing Considerations, Regulatory Challenges, Exosomes and Extracellular Vesicles, MSC Mechanism of Action, Bioprinting for Tissue Regeneration. We also welcome any preclinical studies relevant to the treatment of COVID-19 with MSCs.
Topic editor Joan Oliva is employed by Emmaus Medical Inc. and Topic Editor Mayasari Lim is employed by RoosterBio Inc. All other Topic Editors declare no competing interests with regards to the Research Topic subject.
Keywords: Mesenchymal Stem Cells, MSCs applications, Ex vivo Gene Therapy, GMP Manufacturing Challenges.
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.