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Description of the action
HAPLO-iPS aims to create a collaborative network to provide a framework for hiPSC generation of hiPSC homozygous for frequent HLA haplotypes, compatible with a significant percentage of the population to be used for cell therapy clinical trials and to create a data collection system (REGISTRY) for such lines.
Specific Objectives
The aim of this COST Action is to create a collaborative network to provide a framework for hiPSC generation of hiPSC homozygous for frequent HLA haplotypes, compatible with a significant percentage of the population to be used for cell therapy and to create a data collection system (REGISTRY) for such lines.
Working group 1 is responsible for source material screening, selection, collection, and tracing. Together with immunology and cord blood bank experts from a number of countries, the team shall establish minimum criteria for sample quality, data and traceability in order to develop a common understanding of the (HLA) cord blood sample selection procedure.
Working group 2 is responsible for the generation and characterization of hiPSC. The team shall compare and optimize the methodologies for the generation of hiPSC suitable for the manufacture of therapeutic products and develop a Standard Operating Procedure (SOP) on hiPSC generation from haplo-selected cord blood samples based on assessment of cell preparation/selection and reprogramming methods.
Working group 3 shall identify optimal systems for safety-assured and reliable cell therapies to promote standardization of hiPSC scaling and banking for basic and clinical researchers and regulators. Based on the existing European human Pluripotent Stem Cell Registry (hPSCreg), the team of experts shall define the hiPSC-associated data to be collected and develop a data resource, access platform and registry for available hiPSC lines suitable for the manufacture of therapeutic products.
Working group 4 will bring together expertise in genetic stability and tumorigenicity testing for evaluation of best current scientific practice in cell safety testing and establish a consensus approach to identification and testing for the wider range of acute and emerging infectious diseases beyond the viral infections tested for in transplantation, as well as the regulatory landscape for donation and clinical use of cord blood-derived hiPSC and their derivatives.
Working group 5 will establish a consensus on the management of data handling and protection as well as ethical core documents for donation and clinical use of cord blood-derived hiPSC. WG5 is also responsible for the organization of Working Groups including identification of critical dependencies between their objectives.
Working group 6 is responsible for the establishment of a training and exchange network for young researchers and dissemination of the Action by creating a website, social media activity and participation in meetings and international conferences.
Working group 7 is responsible for the establishment and standardization of protocols for generate hiPSC-derivatives for cell therapy and their scaling. The team shall identify safety and regulatory requirements for transplantation of hiPSC-derivatives and establish transplantation protocols for hiPSC-derivatives therapy (including immunotherapy).
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