Services


Laboratoire de Production Iso 7
© A. Moisan EFS-RA

 

ECELLFRANCE offers to assist academics and industrials with the implementation of their preclinical and/or clinical programs in the field of cell-based therapies.

 

The infrastructure provides services covering the entire MSC-based production and development pipeline:

 

 

Mesenchymal Stem Cell (MSC) production

   Clinical batches meeting the European directive 1394/2007 on ATMP

 

+ Quality control, potency tests and MSC safety testing

 

+ Immunomonitoring of MSC treated patients

   Phenotypic analysis of sub-populations of immune cells

 

+ Preclinical studies

  • MSC efficiency in validated disease models

-    Osteoarticular diseases
-    Auto-immune diseases
-    Cutanuous conditions
-    Ischemia
-    Stroke and neurological disorders

  • Regulatory pre-clinical studies

-    Biodistribution
-    Pharmacotoxicology

 

+ Assistance with regulatory dossier
   Investigator brochure, IMPD, CRF

 

+ Assistance with Phase I and II clinical trials
   Design, methodology, statistics, meeting with the French health authorities (CPP).

 

 

You may apply by filling the application form.

For more information contact us.