The objectives of this study was to test hypothesis that ischemic stroke patients having moderate to severe persistent neurologic deficit will have better outcomes with intravenous transplantation of autologous mesenchymal stem cells (MSCs) expanded with autologous serum that is obtained at acute phase of stroke than patients receiving standard treatment.
In this study, we will use autologous 'ischemic' serum that obtained at the earliest time point as possible (immediate after randomization) for the purpose of ischemic preconditioning. We have recently conducted preclinical studies on the effects of ischemic preconditioning on the MSC functions. We have evaluated the characteristics of rat MSCs after culture with fetal bovine serum (FBS) or serum obtained from rat stroke model. Compared to FBS, the use of serum obtained from rat stroke model resulted in more rapid expansion of MSCs, which reduces cell preparation time by increase in G2/M phase, decreased cell death/senescence, increased trophic factor secretion, and increased migration capacity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
intravenous transplantation of autologous mesenchymal stem cells expanded with autologous serum
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
RECRUITINGCategorical shift in modified Rankin scale (mRS)
Categorical shift in mRS at 90 days after the cell treatment
Time frame: 90 days after the cell treatment
Change of National Institutes of Health stroke scale (NIHSS)
Change of NIHSS between pre- and post-treatment 90 days
Time frame: 90 days after the cell treatment
Early improvement of National Institutes of Health stroke scale (NIHSS)
≥5 points improvement or score of 0-2 on NIHSS score at 14 days after treatment
Time frame: 14 days after the cell treatment
Dichotomized modified Rankin scale (mRS)
mRS ≤2 at 90 days after treatment
Time frame: 90 days after the cell treatment
Change of modified Rankin scale (mRS)
Change of mRS between pre- and post-treatment 90 days
Time frame: 90 days after the cell treatment
Dichotomized modified Barthel index (mBI)
mBI ≥60 at 90 days after treatment
Time frame: 90 days after the cell treatment
Change of modified Barthel index (mBI)
Change of mBI between pre- and post-treatment 90 days
Time frame: 90 days after the cell treatment
Change of gross motor function
Change of Gross motor function (Motricity index and Fugl-Meyer assessment)between pre- and post-treatment 90 days
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Time frame: 90 days after the cell treatment
Change of Fine motor function
Change of Fine motor function (Purdue Pegboard test and Box and block test) between pre- and post-treatment 90 days
Time frame: 90 days after the cell treatment
Change of Mobility
Change of Mobility (Functional ambulatory category and 10m-Gait speed) between pre- and post-treatment 90 days
Time frame: 90 days after the cell treatment
Change of mini-mental status exam (MMSE)
Change of MMSE between pre- and post-treatment 90 days
Time frame: 90 days after the cell treatment
Change of quality of life
Change of EuroQol 5d (EQ-5D) between pre- and post-treatment 90 days
Time frame: 90 days after the cell treatment
Safety outcome
1. Death: All causes of death 2. Recurrence: Recurrent stroke or transient ischemic attack 3. 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,laboratory findings). 4. 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)
Time frame: During 90 days after the cell treatment