E Cell France – Potency test for therapeutic cell

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

Scientific Aim:

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 Involvement:

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.

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