Manufacturing pluripotent stem cells and their derivatives for clinical applications [WEBINAR]
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Human pluripotent stem cells (PSCs) and their derivatives hold great potential in regenerative cell therapies and recently have been used in a number of clinical trials targeting various diseases. For example, PSC-derived retinal pigment epithelial (RPE) cells have been tested in clinical trials for age-related macular degeneration and retinitis pigmentosa.
In this webinar, Chao Sheng will first introduce the established workflow from Miltenyi Biotec for GMP-compliant human PSC expansion using the CliniMACS Prodigy® Adherent Cell Culture process and the iPS-Brew GMP Medium.
Afterward, Christelle Monville will introduce the work done on developing a novel tissue-engineered product (TEP) consisting of RPE cells derived from clinical -grade human embryonic stem cells. These cells were disposed on a biocompatible substrate allowing the formation of a 3D functional sheet suitable for transplantation. After functional validation in a rodent model of Retinitis Pigmentosa (Ben M'Barek et al., 2017), they have tested the safety of the surgery and local tolerance in non-human primates (Ben M’Barek et al., 2020). These results lay the foundations for the start of a phase I/II clinical trial in 2019 that is now ongoing (NCT03963154). 7 patients have been transplanted so far and first results are showing no major adverse events. In parallel, they are developing protocols to upscale the production of RPE using culture automates (Régent et al., 2019) in GMP conditions.
Human pluripotent stem cells (PSCs) and their derivatives hold great potential in regenerative cell therapies and recently have been used in a number of clinical trials targeting various diseases. For example, PSC-derived retinal pigment epithelial (RPE) cells have been tested in clinical trials for age-related macular degeneration and retinitis pigmentosa.
In this webinar, Chao Sheng will first introduce the established workflow from Miltenyi Biotec for GMP-compliant human PSC expansion using the CliniMACS Prodigy® Adherent Cell Culture process and the iPS-Brew GMP Medium.
Afterward, Christelle Monville will introduce the work done on developing a novel tissue-engineered product (TEP) consisting of RPE cells derived from clinical -grade human embryonic stem cells. These cells were disposed on a biocompatible substrate allowing the formation of a 3D functional sheet suitable for transplantation. After functional validation in a rodent model of Retinitis Pigmentosa (Ben M'Barek et al., 2017), they have tested the safety of the surgery and local tolerance in non-human primates (Ben M’Barek et al., 2020). These results lay the foundations for the start of a phase I/II clinical trial in 2019 that is now ongoing (NCT03963154). 7 patients have been transplanted so far and first results are showing no major adverse events. In parallel, they are developing protocols to upscale the production of RPE using culture automates (Régent et al., 2019) in GMP conditions.
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