Objective | Endpoint |
---|---|
Primary endpoint of efficacy: | Â |
Functional outcome | Categorical shift in mRS at 90 days after treatment |
Secondary endpoints of efficacy: | Â |
Disability | Change in NIHSS between pretreatment and 90 days post-treatment ≥5 points improvement or score of 0 to 2 on NIHSS score at 14 days after treatment |
Functional outcome | mRS ≤2 at 90 days after treatment |
Change of mRS between pretreatment and 90 days post-treatment | |
mBI ≥60 at 90 days after treatment | |
Change of mBI between pretreatment and 90 days post-treatment | |
Further demonstration and characteristics of motor recovery | Change of gross motor function between pretreatment and 90 days post-treatment |
Motricity index and Fugl-Meyer assessment (upper, lower) | |
Change of fine motor function between pretreatment and 90 days post-treatment | |
Purdue pegboard test (simple) and box and block test | |
Change of mobility between pretreatment and 90 days post-treatment | |
Functional ambulatory category and 10-m gait speed | |
Cognition | Change of MMSE between pretreatment and 90 days post-treatment |
Quality of life | Change of EQ-5D between pretreatment and 90 days post-treatment |
Secondary endpoints of safety: | Â |
Death | All causes of death |
Recurrence | Recurrent stroke or transient ischemic attack |
The immediate reaction | Allergic reactions (tachycardia, fever, skin eruption, leukocytosis) |
Local complications (hematoma or local infection at the site of bone marrow aspiration) | |
Vascular obstruction (tachypnea, oliguria, or peripheral vascular insufficiency) | |
Systemic complications (infections, AST/ALT, or BUN/Cr levels) | |
Long-term adverse effects possibly related to MSC treatment | Tumor formation (physical examination, plain X ray, f/u MRI at 90 days after treatment) |
Aberrant connections (newly diagnosed seizure or arrhythmia) | |
Other parameters related to efficacy: | Â |
Exploration of biomarkers to further demonstrate the mechanism of action and genetic profile | SDF-1α (chemokine) |
S100β (protection and regeneration) | |
HIF-1 (preconditioning) | |
Circulating MSCs and MSC-derived microparticles | |
BDNF levels and polymorphisms and VEGF levels | |
Multimodal MRI | Resting-state functional MRI and diffusion tensor imaging |
Neurophysiologic study | Motor evoked potentials |