Abstract

Background: The alarming disability burden and a high prevalence rate of Stroke in India has encouraged the researchers to develop new therapies to reduce clinical deficits. Stem cell therapy promises to restore function after stroke evidenced by experimental model studies and clinical trials. These cells are feasibile, multipotent and have homing-in characteristics to the lesioned cortex. The present study evaluates safety, feasibility and efficacy of autologous mononuclear and mesenchymal stem cell therapy in stroke patients evaluated on clinical scores and functional imaging including functional MRI (fMRI) and diffusion tensor imaging (DTI). Methods: Forty (n=40) stroke patients were recruited with the following inclusion criteria: 3 months to one year of index event; power in hand muscles of at least MRC grade 2; NIHSS between 4 and 15; conscious and able to comprehend. Fugl Meyer (FM), modified Barthel Index (mBI), MRC, Ashworth tone scale and functional imaging were used for assessments at baseline, 8 weeks and 24 weeks. Fourteen (n=14) patients were administered mononuclear stem cells and six (n=6) patients cultured expanded mesenchymal stem cells. 50 to 60 million cells were dissolved in 250 ml saline and infused intravenously over 2-3 hours. Twenty patients served as controls. Results: The clinical, laboratory and radiological tests were normal for patients with stem cell therapy. There was no mortality or therapy related adverse reactions. mBI showed statistical significant improvement (p0.05) in the stem cell group as compared to controls. There was an increased number of cluster activation in Brodmann areas BA 4 and BA 6 post stem cell infusion compared to controls. Conclusion: Autologous intravenous stem cell (mononuclear and mesenchymal) therapy is safe and feasible and likely facilitates behavioral recovery after stroke. Stem cells act as “scaffolds” / cellular mediators for neural transplantation and may aid in repair mechanisms in stroke.

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