Preclinical research, including research at the UTHealth Medical School,
has suggested that stem cells can promote the repair of the brain after
an ischemic stroke caused by a blood clot in the brain.
The trial -- the only randomized, double-blind, placebo-controlled intra-arterial clinical trial in the world for ischemic stroke -- is studying the safety and efficacy of a regenerative therapy developed by Aldagen Inc., a wholly-owned subsidiary of Cytomedix, Inc. (CMXI), that uses a patient’s own bone marrow stem cells administered between 13 and 19 days post-stroke.
In a very small trial that may suggest the possibility of significant future results, the PISCES study conducted at the University of Glasgow with scaled fetal neural cells produced by ReNeuron Group is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, ReNeuron’s ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. ReNeuron is located in the UK and is traded on the London AIM market under the symbol RENE.L.
To date, six patients have been treated in the PISCES stroke study, representing the first two of four dose cohorts. The interim data being presented are from the first five patients treated, at 2 x 12 month, 1 x six month and 2 x three month follow-up points.
Reductions in neurological impairment and spasticity were observed in all five patients compared with their
