Nerve disorders are largely divided into brain disorder and spinal cord disorder, and FCB-Pharmicell has both domestic and foreign patents on nerve cell activity technology using stem cells. As part of the next generation growth project of the Ministry of Health and Welfare we are developing drugs for cerebral hemorrhage, brain infarction, Parkinson's disease and traumatic brain disease, and especially received authorization of clinical tests for commercialization of the brain infarction treatment drug from the KFDA in 2005(IND-III). We are preparing for clinical tests for commercialization for spinal cord disorder patients based on our positive clinical spinal disorder drug tests.

Mesenchymal stem cell (MSC) transplantation improves recovery from ischemic stroke in animals. We examined the feasibility, efficacy, and safety of cell therapy using culture-expanded autologous MSCs in patients with ischemic stroke. We prospectively and randomly allocated 30 patients with cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits into one of two treatment groups: the MSC group (n=5) received intravenous infusion of 1×108 autologous MSCs, whereas the control group (n=25) did not receive MSCs. Changes in neurological deficits and improvements in function were compared between the groups for 1 year after symptom onset. Neuroimaging was performed serially in five patients from each group. Outcomes improved in MSC-treated patients compared with the control patients: the Barthel index (p= 0.011, 0.017, and 0.115 at 3, 6, and 12 months, respectively) and modified Rankin score (p= 0.076, 0.171, and 0.286 at 3, 6, and 12 months, respectively) of the MSC group improved consistently during the follow-up period. Serial evaluations showed no adverse cell-related, serological, or imaging-defined effects. In patients with severe cerebral infarcts, the intravenous infusion of autologous MSCs appears to be a feasible and safe therapy that may improve functional recovery.

Changes in infarct volume were not observed in both groups (A), but ventricular dilations secondary to atrophic changes of periinfarct area were more prominent in the control group than in the mesenchymal stem cell group (B). (C) Volumetric analysis of infarct size (left) and ventricular size (right). Asterisk indicates volume ratio of lesions on fluid-attenuated inversion recovery image performed at 1 year after symptom onset to initial diffusion-weighted imaging lesions. Dagger indicates volume ratio of the lateral ventricle of symptomatic side to the contralateral lateral ventricle.