A NOVEL APPROACH TO GMP PRODUCTION, CRYOPRESERVATION AND DISTRIBUTION OF TOOTH DE
Small Business Information
GENERAL BIOTECHNOLOGY, LLC
1102 INDIANA AVE. (formerly STADIUM DR.), INDIANAPOLIS, IN, 46202
AbstractDESCRIPTION (provided by applicant): The overall goal of this proposal is to build on our understanding of the collection, processing and cryobiological characteristics of stem/progenitor cells recovered from extracted teeth with the ultimate culmination of these data to develop a cryobank of dental pulp derived stem cells (DPSCs) for research and/or potential transplant or other clinical utilization as a human cell product processed under current good tissue practice (cGTP) as described under 21 CFR 1271. Recent studies investigating this exciting source of post-natal stem cells have identified a population of clonogenic and highly proliferative cells derived from enzymatically digested dental pulp tissue (Gronthos et al., 2000; Perry et al., 2008). Result s from these studies have indicated that these cells may have the potential to be utilized in stem cell mediated therapies as well as tissue engineering applications (Seo et al., 2005). To allow further study and potential therapeutic use of these cells, o ur group has begun to evaluate the ability of these cells and their respective tissues of origin to survive cryopreservation processing. Ideally, the optimum cryopreservation process will be straight forward and effective when applied to the tissue as a wh ole, with the idea that stem cells could be extracted post-thaw. The rationale for this would be to preserve clinical samples for subsequent stem cell recovery as it is reasonable to speculate that cryopreservation of tissues in the clinic will be more pra ctical than direct primary isolation of stem cells, which would require additional equipment and personnel (Seo et al., 2005; Perry et al., 2008). A cryobank of these cells would add great flexibility to their use by allowing, among other things, shipment of cells to investigators and/or clinicians and adequate time for donor characterization and/or potential testing. To achieve this overall goal, we propose the following Specific Aims: (I) Final development of optimized, cGTP protocols for development of a tooth stem cell bank for distribution and use; (II) Final development cGTP protocols for cryobanking of tooth tissue for later stem/progenitor cell isolation and expansion; and (III) Development and validation of a closed container for packaging and distr ibution of cells for clinical use. The ultimate goal of the proposal is a cryobank of DPSCs or tissue with e90% consistent functional recovery of cells based on the most sensitive assays available when compared to their unfrozen counterparts. For Specific Aim III the goal will be an FDA approved packaging system useful for clinical utilization of stem/progenitor cells derived from teeth. This system will also be useful for other clinically relevant stem cell sources where smaller volumes are required. PUBLIC HEALTH RELEVANCE: Stem cells can develop into different tissues types in the body. Post-natal or adult stem cells offer an alternative to obtaining stem cells from embryos. Such stem cells exist in human teeth, but more research is required b efore these cells can have direct clinical use. A bank of frozen stem cells from teeth would be ideal to facilitate this research. This proposed project would optimize methods for processing and freezing these cells for ease of distribution for research, t esting, and eventually clinical use, as well as present the ability for one to store tissue from their own teeth for potential use of their own cells if/when needed.
* information listed above is at the time of submission.