SanBio has completed a two year, Phase 1/2a clinical trial of the Company's most product, SB623, to assess its safety and efficacy in patients with chronic neurological deficits resulting from ischemic stroke.
The study found no serious adverse events attributable to SB623. In particular, no data showing immunological reactions (i.e., formation of antibodies to donor cells) or tumor formation were found. And, statistically significant improvements in patient’s motor impairment were observed in this study.
In June 2014, the US Food and Drug Administration (FDA) reviewed the results of the Phase 1/2a study and approved advancing clinical development to Phase 2b. The phase 2b trial began to recruit patients in the United States in December 2015.
Results of the Phase 1/2a Trial
SB623 administration improved motor function in a number of patients in the phase 1/2a trial. These subjects included those with disabilities such as inability to raise their arms and inability to walk. Following SB623 administration, significant improvements in motor function were observed in some patients. For example, one patient regained her ability to raise her arms, and another who had required a wheelchair regained the ability to walk without support.
Chair of Dept. Neurosurgery, Professor Gary Steinberg (Principal Investigator for the clinical trial)
※Results of our clinical trial (Watch the first half from 2:10 to 3:35 for two patients’ status before and after the trial.)
You can see in this video that as a result of the administration of regenerative cell medicine SB623 to patients 2 years after the onset of stroke, one patient who had not been able to raise her arms came to be able to raise her hands over her head, and she also reported that her speech improved. Another patient who had required a wheelchair and was unable to move her leg could stand up and was able to walk.
Below, these results are plotted on the Fugl–Meyer (Motor) Scale, a typical index to measure motor function. The patients' continuous motor function improvement is clearly demonstrated.