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Cell therapy
• Successful clinical translation needs consistent high quality hPSCs and
derivatives that assure safety and efficiency to the patient.
• Differences in embryos or cell types of origin, reprogramming methodologies, reagents, culture conditions, differentiation protocols, create significant variability in the generated products.
• Need for robust and standardised methodology.
• Need for preclinical development, guided by the appropriate regulatory body, such as Food and Drug Administration (FDA) in US or the European MedicinesAgency (EMA) in Europe
• hPSC derivatives classified as Advanced Therapy Medicinal Products (ATMPs) (FDA and EMA).
• Production under current Good Manufacturing Practice (cGMP) conditions. PCC Stem Cells - ESHRE Vienna 2019
The Global Alliance for hiPSC Therapies
(GAiT) http://www.globalallianceforipsctherapies.com
• Initiative to support the implementation and clinical application of therapies derived from pluripotent stem cells.
• Supported by an international consortium of organizations including the Cell and Gene Therapy Catapult (London, UK), the Centre for Commercialization of Regenerative Medicine (Toronto, Canada), the Korea HLA- Typed iPSC Banking Initiative (Seoul, Korea) and the New York Stem Cell Foundation (New York, USA).
• Central, international resource for organizations developing therapies from clinical-grade hiPSC.
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