Description of the action
HAPLO-iPS aims to create a collaborative network to provide a framework for hiPSC generation
The aim of the COST Action HAPLO-iPS is to establish a collaborative network that provides a framework for generating human induced pluripotent stem cells (hiPSC) homozygous for frequent HLA haplotypes. These hiPSC lines will be compatible with a significant percentage of the population, allowing their use in cell therapy clinical trials. Additionally, the network aims to develop a data collection system based on the hPSCreg registry for human pluripotent stem cell lines.
HAPLO-iPS will create an excellence network based in Europe, focusing on hiPSC-derived cell-based medicines. This network not only aims to advance the state-of-the-art in this research field but also contributes to Europe’s global leadership in medical, scientific, economic, and social development. By strengthening Europe’s competitiveness capacities, the network involves key stakeholders such as hiPSC generation/banking centers, cord blood banks, manufacturing centers compliant with Good Manufacturing Practices (GMP), immunology experts, chemistry and manufacturing controls professionals, regulatory bodies, national agencies, and ethics experts. The approach to this challenge involves networking among stakeholders, sharing knowledge, standardizing methodologies, and developing an educational training program for researchers.
HAPLO-iPS also promotes the participation of researchers from less research-intensive countries, as a significant percentage of the members come from these countries. Participants from these countries will have access to research facilities, training courses, and mentoring programs for young researchers, contributing to spreading excellence and widening participation. Furthermore, key leadership positions in the Action Management are reserved for COST ITC members.
Overall, this project pioneers new approaches that will drive the progress of haplo-selected hiPS generation for therapeutics. It achieves this through the development, implementation, and exploitation of a registry that consolidates all relevant information for the benefit of patients.
Objectives
Specific Objectives
- Develop a common understanding of the cord blood sample selection procedure;
- Coordinate information seeking, tracing, collection, and data curation of selected samples;
- Compare and optimize methodologies for generating hiPSC for therapeutic product manufacturing;
- Establish core requirements for evaluating hiPSC suitability, including differentiation potential and reprogramming vector elimination;
- Assess genetic stability and tumorigenicity testing for cell safety;
- Identify and test for a wider range of infectious diseases;
- Develop a data resource and access platform for hiPSC used in therapeutic product manufacturing;
- Establish ethical guidelines, regulatory landscape, and navigation support for CB-derived hiPSC donation and clinical use;
- Address medico-economic issues and develop a sustainability model;
- Identify optimal systems for safety-assured and reliable cell therapies to promote standardization.
- Promote knowledge exchange on hiPSC generation for cell therapy product manufacturing;
- Facilitate networking among stakeholders involved in producing suitable cell lines;
- Foster a multi- and interdisciplinary approach between scientists, clinicians, standards organizations, regulators, and ethics experts;
- Serve as a platform for applying hiPSC-based cell therapy and exploring network value for other areas of cell-based medicine;
- Provide training, educational programs, and exchange opportunities for young scientists and clinicians across member states.
