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CYTX Phacilitate Cell & Gene Therapy Forum
1. Unique Challenges with Autologous Cell Therapies Kenneth K. Kleinhenz Vice President Regulatory Affairs and Quality Assurance Phacilitate Cell & Gene Therapy Forum The Grand Hyatt, Washington, D.C. January 24-26, 2011 1
27. US Food and Drug Administration Considerations
28. Key US FDA Regulations 21 CFR 1271.15(b) â you are not required to comply with the requirements of this part if you are an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure.
29. Minimally Manipulated Autologous Peripheral Blood Stem Cell Draft Guidance Document -2007 For autologous PBSCs processed at the clinical site, the presence of all the following 5 factors supports the conclusion that the cells are removed and subsequently implanted in the âsame surgical procedureâ and, therefore, compliance is not required. The cells are autologous and are intended for use for a specific clinical indication The cells are minimally manipulated The device is solely responsible for the production of the autologous cells (i.e., no other manufacturing steps take place outside of the device other than the recovery of the source cells) The cells are used within a short period of time (i.e., they are not stored or shipped) The device and selected cells are only used at the point of care (i.e., cell processing is performed at and by the clinical site where cells are directly administered).
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31. The HCT/P in intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturerâs objective intent
32. The manufacture of the HCT/P does not involve the combination of the cell or tissue component with a drug or a device, except for a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the HCT/P, and
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34. Is for allogeneic use in a 1st degree or 2nd degree blood relative, or