hiPSC-derivatives production and Transplantation
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).
Objectives
- Establishment and standardization of protocols for generate hiPSC-derivatives for cell therapy and their scaling.
- Establishment of safety and regulatory requirements for hiPSC-derivatives transplantation.
- Establishment of transplantation protocols for hiPSC-derivatives therapy (including immunotherapy).
- Follow up of clinical trials.
WG7 Leaders
Description of Work
T7.1
Literature review on differentiation protocols for generate the most demanded hiPSC-derivatives for manufacture of cell-based medicines and cell manufacturers and regulatory experts meeting selection of the most suitable method for generate hiPSC-derivatives for cell therapy and their scaling. (Selection of SOP’s).
T7.2
Literature review on clinical trials with hiPSC-derivatives and cell therapy and cell manufacturers, clinical researchers, immunologists and regulatory experts meeting establishment of safety and regulatory requirements for cell therapy with hiPSC-derivatives.
T7.3
Development of a data resource and access platform and registry for clinical trials with hiPSC-derivatives on the existing European human Pluripotent Stem Cell Registry (hPSCreg) and for the follow-up of clinical trials with hiPSC-derivatives on the existing European human Pluripotent Stem Cell Registry (hPSCreg).
Deliverables and milestones
D7.1
Standard Operating Procedure’s for the recommended hiPSC differentiation protocols and their scaling. (M36).
D7.2
Summary of safety, clinical and regulatory requirements for cell therapy with hiPSC-derivatives (M48). D7.3: Report on Database for inclusion of clinical trials and their follow-up in hPSCreg (M48).
M7.1
Selection of the most suitable method for the manufacturing and scaling of hiPSC derivatives for cell therapy.
M7.2
Evaluation of the safety and regulatory requirements for cell therapy with hiPSC-derivatives.
M7.3
Evaluation of the clinical and immunological requirements for cell therapy with hiPSC-derivatives.
M7.4
Provide a tool for Registry and Follow up of clinical trials with hiPSC-derivatives.
