REgenerative Stem cell therapy for STroke in Europe
Call identifier: H2020-PCH-2015-RTD
Grant agreement nº: 681044
This project has received funding from the European Community's Horizon 2020 Programme under grant agreement no. 681044.
The primary objective of the RESSTORE translational project is to provide, through a European multicentre randomised phase IIb clinical study, essential information on the therapeutic efficacy of IV delivery of allogenic adipose tissue derived MSCs (ADMSCs) in 400 stroke patients.
More precisely, RESSTORE objectives are:
- To demonstrate the clinical efficacy and safety of ADMSC on functional recovery in 400 stroke patients with a main primary endpoint at 3 months after stroke onset and a 2-year follow-up
- To assess and monitor in patients the expected restoring effects of ADMSC using novel biomarkers (multimodal MRI and blood markers).
- To validate the societal value and cost-effectiveness of cell-based regenerative in real conditions based on health economics and predictive in silico (virtual population) models
- To define in experimental murine stroke models i) whether or not the treatment response can be further enhanced by intensive rehabilitation and ii) the mechanism(s) underlying the therapeutic effect.
In this project, HISTOCELL is going to be involved in the production, control (identification, safety and functionality) and release of the Adipose derived Mesenchymal Stem Cells (ADMSC) (Tissue Engineered Advanced Therapy Medicinal Products, EMA/CAT/600280/2010). According to a harmonized manufacturing process under cGMP conditions Histocell, as well as the Cell Therapy Units of Málaga Hospital (Spain) and of Tampere University (Finland), will deliver the Working Banks (MSC to be injected in patients).