Journal ArticleDOI
FDA Regulation of Stem-Cell–Based Therapies
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The authors review existing regulations regarding cell and tissue products and discuss how they expect the Food and Drug Administration to apply these regulations to scientists' efforts to develop and test stem-cell–based therapies.Abstract:
The authors review existing regulations regarding cell and tissue products and discuss how they expect the Food and Drug Administration to apply these regulations to scientists' efforts to develop and test stem-cell–based therapies.read more
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Human Alternatives to Fetal Bovine Serum for the Expansion of Mesenchymal Stromal Cells from Bone Marrow
Karen Bieback,Andrea Hecker,Asli Kocaömer,Heinrich Lannert,Katharina Schallmoser,Dirk Strunk,Harald Klüter +6 more
TL;DR: PHPL was found to be the most suitable FBS substitute in clinical scale BM‐MSC expansion and quality and functionality including cell surface marker expression, adipogenic and osteogenic differentiation, and immunosuppressive action were similar in MSCs from all culture conditions.
Journal ArticleDOI
Teratoma formation by human embryonic stem cells: evaluation of essential parameters for future safety studies.
TL;DR: The teratoma assays are considered the gold standard for demonstrating differentiation potential of pluripotent human embryonic stem cells and hold promise as a standard for assessing safety among hESC-derived cell populations intended for therapeutic applications.
Journal ArticleDOI
The potential of adipose stem cells in regenerative medicine.
TL;DR: The safety, reproducibility and quality of the stem cells must thoroughly be examined prior to extensive use in clinical applications, as cell therapies are becoming more frequent and the need for control in the processing laboratory grows consequently involving a greater risk of complications and possibly adverse events for the recipient.
Journal ArticleDOI
Synthetic alternatives to Matrigel.
TL;DR: The limitations of Matrigel are discussed and synthetic alternatives for stem-cell culture, regenerative medicine and organoid assembly are highlighted and xenogenic-free, chemically defined, highly tunable and reproducible alternatives are highlighted.
Journal ArticleDOI
The Systematic Production of Cells for Cell Therapies
TL;DR: Bioprocess engineering fundamentals need to be combined with cellular systems biology principles to guide the development of next-generation technologies capable of producing cell-based products in a safe, robust, and cost-effective manner.
References
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Journal ArticleDOI
Embryonic Stem Cell Lines Derived from Human Blastocysts
James A. Thomson,Joseph Itskovitz-Eldor,Sander S. Shapiro,Michelle A. Waknitz,Swiergiel Jennifer J,Vivienne S. Marshall,Jeffrey M. Jones +6 more
TL;DR: Human blastocyst-derived, pluripotent cell lines are described that have normal karyotypes, express high levels of telomerase activity, and express cell surface markers that characterize primate embryonic stem cells but do not characterize other early lineages.
Journal ArticleDOI
Islet Transplantation in Seven Patients with Type 1 Diabetes Mellitus Using a Glucocorticoid-Free Immunosuppressive Regimen
A. M. J. Shapiro,Jonathan R. T. Lakey,Edmond A. Ryan,Gregory S. Korbutt,Ellen L. Toth,Garth L. Warnock,Norman M. Kneteman,Ray V. Rajotte +7 more
TL;DR: The observations in patients with type 1 diabetes indicate that islet transplantation can result in insulin independence with excellent metabolic control when glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet mass.
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Clonally Derived Human Embryonic Stem Cell Lines Maintain Pluripotency and Proliferative Potential for Prolonged Periods of Culture
Michal Amit,Melissa K. Carpenter,Margaret S. Inokuma,Choy-Pik Chiu,Charles P. Harris,Michelle A. Waknitz,Joseph Itskovitz-Eldor,James A. Thomson +7 more
TL;DR: The clonal derivation of two human ES cell lines, H9.1 and H.2, demonstrates the pluripotency of single human ES cells, the maintenance of pluripOTency during an extended period of culture, and the long-term self-renewing properties of cultured human ES Cells.
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Stem cell therapy for human neurodegenerative disorders-how to make it work.
TL;DR: Findings raise hope for the development of stem cell therapies in human neurodegenerative disorders and need to know much more about how to control stem cell proliferation and differentiation into specific phenotypes, induce their integration into existing neural and synaptic circuits, and optimize functional recovery in animal models closely resembling the human disease.
Journal ArticleDOI
Immunological reconstitution of sex-linked lymphopenic immunological deficiency
TL;DR: Treatment of a 5-month-old male with sex-linked lymphopenic immunological deficiency utilising immunologically competent cells from peripheral blood buffy coat and bone-marrow of a sibling donor resulted in reconstitution of both cellular and humoral immunity.