Abstract
Cell therapy practices date back to the 19th century and continue to expand on investigational and investment grounds. Cell therapy includes stem cell- and non–stem cell-based, unicellular and multicellular therapies, with different immunophenotypic profiles, isolation techniques, mechanisms of action, and regulatory levels. Following the steps of their predecessor cell therapies that have become established or commercialized, investigational and premarket approval-exempt cell therapies continue to provide patients with promising therapeutic benefits in different disease areas. In this review article, we delineate the vast types of cell therapy, including stem cell-based and non–stem cell-based cell therapies, and create the first-in-literature compilation of the different “multicellular” therapies used in clinical settings. Besides providing the nuts and bolts of FDA policies regulating their use, we discuss the benefits of cell therapies reported in 3 therapeutic areas—regenerative medicine, immune diseases, and cancer. Finally, we contemplate the recent attention shift toward combined therapy approaches, highlighting the factors that render multicellular therapies a more attractive option than their unicellular counterparts.
Highlights
Cell therapy refers to the transfer of autologous or allogeneic cellular material into a patient for medical purposes [1, 2]
Besides its use as an investigational product in different clinical settings [186,187,188], stromal vascular fraction (SVF) is used as a source to isolate adult stem cells (ASCs), which can constitute up to 10% of its fraction depending on the processing technique, usually involving serial straining and centrifugation of SVF and cell culture in growth media [189]
Tissues, and cellular and tissue-based products (HCT/P) are defined by the FDA under the Title 21 of the Code of Federal Regulations (CFR) Part 1271.3(d), or [21 CFR Part 1271.3(d)], as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”
Summary
Cell therapy refers to the transfer of autologous or allogeneic cellular material into a patient for medical purposes [1, 2].
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
