Workpackage 4 : Clinical trial
The main objective of this Workpackage is to coordinate the clinical trial and monitor its progress by providing operational support in all countries.
The specific objectives of this Workpackage are to :
- To design phase 2b clinical trial efficiently, with highest quality and according to Good Manufactoring Practice (GMP), Good Clinical Practice (GCP) and the national and international regulations.
- To conduct prospective, multicenter double blinded, placebo controlled phase 2b study, using culture-expanded, allogeneic adult BM-MSCs in subjects with chronic Low Back Pain (LBP) (> 6 months) due to moderate Degenerative Discopathy Disease (DDD) at one lumbar level from L1 to S1 and unresponsive to conservative therapy for at least 6 months (including physical therapy).
- To analyse and report the data of the trial
- To determine the biological effect of allogeneic MSC on recipient immune response
Several partners particpate to the clinical trial as CHUM, UNAV, UVa, ITRT, APHP, CHU of Nantes, ECRIN-ERIC, BG-BMT, UCBM and UM.