Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
4 doses
placebo
CHU Grenoble Aples
Grenoble, France
RECRUITINGPhase Ia (Toxicity study)
cell-related serious adverse event
Time frame: 7 days after stroke onset
Phase Ib (Dose-effect study)
modelling the dose-effect
Time frame: 6 months after stroke onset
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability
Adverse events report and mortality over 2 years
Time frame: through study completion (2 years)
Functionnal recovery
NIHSS Evolution (0-42) over 2 years
Time frame: through study completion (2 years)
Post stroke handicap
Modified Rankin scale (0-6) over 2 years
Time frame: through study completion (2 years)
Motor recovery
Fugl Meyer score (0-226) assessed by physiotherapist over 6 months post-stroke
Time frame: over 6 months post-stroke
fMRI recovery
activation fMRI and resting state fMRI at 6 months after stroke
Time frame: at 6 months post-stroke
Blood biomarkers for stroke recovery
selection of candidate biomarkers for stroke recovery
Time frame: at 6 months post-stroke
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