Prospective, single center, open label, phase I/IIa escalating dose study. To evaluate the safety and efficacy of escalating doses of SCM-010 in subjects with SPMS.
Twelve (12) SPMS subjects will be enrolled in this study in two dose cohorts. Each subject will receive SCM- 010 by intrathecal (IT) administration at baseline and will be followed up for 24 weeks for efficacy and 48 weeks for safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
SCM-010 is comprised of adipose derived expanded mesenchymal cells (ADSC), suspended in Plasma-Lyte and intended for intrathecal (IT) administration.
Tel Aviv Medical Center
Tel Aviv, Israel
Adverse Events (AEs) reported during the trial
Safety data will be collected following the one IT administration of SCM-010 at baseline visit
Time frame: 48 weeks
Change in MRI scans from baseline
Changes in lesions from baseline MRI scan.
Time frame: 24 weeks
Change from baseline in EDSS score
The Expanded Disability Status Scale (EDSS) will be measured during the study. range of the scale 0-10
Time frame: 24 weeks
Time to Confirmed Disease Progression (CDP)
CDP for an individual subject is defined as at least 3-months confirmed EDSS increase from baseline. The Expanded Disability Status Scale (EDSS) will be measured during the study. range of the scale 0-10
Time frame: 24 weeks
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