Exploratory endpoints
Disability, atrophy, cord gadolinium-enhancing lesions
ATROPHY
In addition to safety endpoints, we evaluated exploratory endpoints to obtain preliminary data on the possible Disability and cognitive progression assessed through:Expanded Disability Status Scale (EDSS)9-Hole Peg Test (9-HPT) in dominant hand (DH) and non-dominant hand (NDH)Symbol Digit Modalities Test (SDMT)Longitudinal changes in:Motor-evoked potentials (MEP)Somatosensory-evoked potentials (SEP)Visual-evoked potentials (VEP)Optical coherence tomography (OCT): peripheral retinal nerve fiber layer (pRNFL) thicknessBrain and spinal cord MRI measures:Number and volume of brain and spinal cord T2 lesions, number of new lesions and changes in T2 lesion volume at weeks 48 and 96Total brain and spinal cord gadolinium-enhancing lesions at baseline, weeks 48 and week 96Brain and spinal cord annualized atrophy rates, as defined by percentage in brain volume and spinal cord cross-sectional area changes from baseline to week 96Longitudinal plasma measurement of NfL, GFAP, UCH-L1 and TAUCSF analysis at baseline and 3 months after the transplantation:Donor-recipient chimerismImmunological profileMetabolomic and proteomic profile