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Table 1 Primary objectives of the MESEMS project

From: MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis

Aim

Measures

Safety of IV therapy with autologous BM-derived MSC in RRMS, SPMS, and PPMS subjects

Number and severity of AEs within each treatment arm

Activity of autologous BM-derived MSCs in MS subjects

Reduction compared to placebo in the total number of contrast-enhancing lesions (GEL) at MRI acquired on conventional MRI scans (minimum magnetic field intensity 1.5 T) over 24 weeks