score entreat admission to the hospital: 16.2 ± 7.85; complete recanalization after treatment (TICI score 2b-3) was 60.3%. The rate of functional independence (90 day mRS score of 0 -2) was 34.6%; the death rate was 17.9%; intracranial hemorrhage and symptomatic hemorrhage rate was 22.5% and 10.1%, respectively. Thrombolysis and thrombectomy are important treatments that can reduce disability (not mortality) in some patients after acute ischemic stroke; however, it is necessary to introduce higher quality and safe services. For this purpose, a better integrated approach to stroke care in Vietnam needs to be developed.
Objective: To assess the safety and the efficacy of intravenous infusion of autologous bone marrow-derived stem cells (BMSC) in subacute middle cerebral artery (MCA) infarct. Subject and method: A prospective, open-label, non-randomized was performed in patients with MCA infarct, within 7-40 days from onset. Sixty-three patients, satisfying the inclusion criteria, were enrolled, and allocated into the IV-BMSC group (n = 32) or into control group (n = 31). Main follow-ups were at 6 months and 1 year after therapy. Adverse events were noted to conclude safety outcome. The primary efficacy outcomes were proportions of patients achieving a score of 0 to 2 on the modified Rankin Scale (mRS). The secondary efficacy outcomes were evaluated by the National Institutes of Health Stroke Scale (NIHSS), Barthel index (BI), Brunnstrom stages of hand (BRS-H), and infarct volume on head MRI. Result: There were no statistically significant differences in the rates of noted adverse events. There were no significant differences between the two groups on the proportions of the mRS 0-2 at both 6-month and 1-year follow-up (3.2% vs 6.9% with p=0.6, and 6.9 vs 9.7 with p=1.0, respectively). The improvement of BI at 6 months was significantly better in the IV-BMSC group compared to control group, however no significant differences on other secondary efficacy measures. Conclusion: Intravenous infusion of BMSC was safe in patients with subacute MCA infarct. Although the difference in the primary efficacy outcomes was not statistically significant, a favorable secondary outcome was observed in IV-BMSC group, presenting by the statistically significant improvement of the Barthel index at 6-month follow-up.
Objective: To implement the process and to evaluate the effectiveness of extracting necessary stem cell components and removing unnecessary cell components. Subject and method: 57 patients (40 male and 17 female patients) with subacute ischemic stroke (7th day - 30th day) including 40 male and 17 female patients. 240ml of bone marrow taken from iliac crests of each patient had diluted in 60ml of heparin solution for anticoagulation. Then, we continued to implement concentration process to reduce the volume in order to remove erythrocytes, granulocyte cells, concentrate process on mononucleus cells (including stem cells). Result: After the process, the components of stem cell package collected after concentrating were as follows: The bone marrow-derived stem cell product had the mean concentration of nucleus cells which was 29.07 ± 18.29G/l, the mean concentration of CD34+ stem cells was 549.79 ± 378.55 cells/pl; the rate of CD34+ in total nuclear cells was 1.87 ± 0.94% and the viable CD34+ rate was 94.65 ± 4.62%. The retain ratio of CD34+ stem cells was 57.64 ± 32.35% equivalent to the mean total number of CD34+ stem cells which was 10.99 ± 7.37 × 106 cells. Removal ratio of granulocyte and erythrocyte was 90.09 ± 10.82% and 99.59 ± 0.23%, respectively. Conclusion: The process of creating autologous bone marrow-derived stem cell product for the treatment of patients with subacute ischemic stroke has been effectively performed in term of collecting useful stem cells and eliminating unnecessary cell components.
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