About this Research Topic
For the past 20 years, mesenchymal stromal cell (MSC) have become the most studied cell type in the development of adult cell therapies for disease treatment. MSC can differentiate into many types of cells (neurons, hepatocytes, myoblast…) and this is one reason why MSCs hold great promise to the treatment of many immune diseases, cardiac and neurological injuries, and tissue regenerative applications. In addition, MSCs have a low immunoreactivity, because of the very low expression of HLA-DR. Xenotransplantation of the MSC support their low immunoreactivity, even if MSC immunotolerance is still on debate. In addition, MSCs can be used as Trojan horses as they can be genetically modified to release proteins of interest, or they can also be used in the 3D printing to bioengineer organs. Basic research has lit the pathway toward our understanding of MSC’s regenerative properties leading to the increase of its use in clinical trials.
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.
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.
