ReNeuron Group plc announces that positive data from a pivotal pre-clinical study using its lead CTX neural stem cell line in a stroke model has been published online in the leading journal Stem Cells.
The study was conducted in conjunction with Dr. Mike Modo and colleagues at the Institute of Psychiatry, King’s College London, prior to Dr. Modo’s recent move to the McGowan Institute for Regenerative Medicine, University of Pittsburgh. The first clinical application for the CTX cell line is ReNeuron’s ReN001 stem cell therapy for disabled stroke patients, currently in Phase 1 clinical development.
The data show significantly improved outcomes in the key behavioral tests in the CTX cell-treated group in a validated rodent model of stroke disability. A gradual improvement in function was observed between 4 and 12 weeks post-implantation of the CTX cells. Where stroke damage was confined to the striatal region of the brain, up to 83% recovery of sensorimotor function was recorded in the cell-treated group. Up to 20% of the CTX cells were seen to differentiate into astrocytes in the cell-treated group, a neuronal cell type associated with behavioral improvements in the chronic phase of stroke. Furthermore, implantation of the CTX cells restored Collagen IV expression to almost control levels, indicating restoration of damaged blood vessels and the formation of new blood vessels in the damaged striatal region of the brain, via the process of angiogenesis.
These results build on the findings of previous efficacy and mode-of-action studies with the CTX cells, confirming their efficacy in models of stable state stroke damage and providing further evidence of the ways in which the cells may promote recovery of function in these models. This study also demonstrates that the size and location of the stroke lesion is an important determinant of the degree of functional recovery seen, as is the site of implantation of the cells. Taken together, these findings therefore provide valuable information to assist in the clinical development of ReNeuron’s ReN001 stem cell therapy for disabled stroke patients, both in terms of the size and location of stroke lesion targeted and the optimum route of administration of the CTX cells.
Dr. John Sinden, Chief Scientific Officer of ReNeuron, commented, “We are delighted to see the results of this important and confirmatory pre-clinical efficacy study with ReNeuron’s CTX stem cell line accepted for publication. The degree of recovery of motor function seen in this study is striking. The results build on earlier published data using the CTX cell line in models of stroke disability and confirm the strength of ReNeuron’s position in the development of cell-based treatments for eligible stroke patients disabled by ischemic stroke, a patient population who currently have no treatments available to them. The data from this study also fully validate the clinical approach adopted in the ongoing PISCES clinical trial with our ReN001 stem cell therapy for disabled ischaemic stroke patients.”
Date: January 3, 2012
Source: ReNeuron Group plc