Abstract

Background: To evaluate the efficacy and safety of hESC therapy on 22 patients with CVA. Materials and methods: The present study included patients with CVA and was conducted between 29 Dec 2004 and 03 Oct 2011 at a single site in New Delhi, India. The study consisted of six treatment phases (T1, T2, T3, T4, T5, and T6), each phase separated by a gap phase. Patients were evaluated for improvement on the basis of European Stroke Scale (ESS) at baseline and at the end of each treatment period. The ESS scores ranged from 0 (minimum score) to 100 (maximum score). Results: A total of 22 patients were included and all received intensive dosing with hESCs in T1. Eight patients returned for T2, 6 patients for T3, 4 patients for T4, and only 2 patients each for T5 and T6. Median ESS scores increased from baseline through all the treatment periods indicating improvement in the condition of patients. All affected patients showed an improvement in gait (22 patients); speech (15 patients); level of consciousness (2 patients); comprehension and gaze (1 patient each) by at least one point at the end of T6. In addition, patients showed improvement in walking, balance (sitting and standing), and spasticity after receiving hESC therapy. Overall, 11 patients (50%) experienced adverse events (AEs) during the study. No serious adverse events (SAEs) and deaths were reported. Conclusion: All the patients showed improved cognitive skills and regained their functional ability. No severe AEs or SAEs were reported during the study. hESC therapy was well tolerated among all the patients included in the study.