ECellFrance (www.ecellfrance.com) is a national network for adult’s MSC-based therapy development. ECellFrance offers to assist both academic and industrial partners with the implementation of their pre-clinical and/or clinical programs in the emerging field of cell-based therapies. The ECellFrance network for regenerative medecine provides services covering the entire MSC-based production and development pipeline:
- MSC production
- Safety and potency tests for MSC
- Immunomonitoring of MSC-treated patients
- Pre-clinical development of MSC-based medicinal products
- Regulatory support services
- Clinical trial support services for phase I and phase II trials
Currently, adult MSCs are increasingly used in clinical trial. Production, development and use of MSC-based medical products require safety and potency test. Toulouse platform STROMALab is intended to provide new quality control test in order to improve MSCs-production safety but also new potency assay in order to evaluate MSCs functional ability before therapeutic administration.
STROMALab laboratory is involved in ECellFrance national network at different levels:
- It provides its MSCs and ASCs (adipose tissue derived mesenchymal stem cell) expertise. This team is involved in the field of :
- Safety and potency test standardization of MSC/ASC based-medicinal products.
- Genetic stability of CSM/ASC.
- Regenerative and immunomodulatory property of MSC and ASC.
- Ischemic diseases
- In collaboration with EFS, it provide expertise for the national network in:
- GMP production of Advanced Therapy Medicinal Products (ATMP) in accordance with regulation in EFS production platform (Toulouse, Créteil, Grenoble and Besançon).
- Manufacturing processes development.
- Drafting of Investigational Medicinal Product Dossier (IMPD) for clinical trial.
Both team’s managers are involved in steering and scientific advisory board.
- BD LSR Fortessa Cell Analyzer, 5 lasers which enables the detection of up to 18 colors simultaneously.
- BD Canto II Cell Analyzer, 8 colors.
- BD FACSAria Fusion Cell Sorter, 4 lasers.
- Perkin Elmer Operetta High Content Screening Systems.
- Amnis ImageStreamX Mark II Imaging Flow Cytometer.