International Stem Cell Corporation Announces Successful Completion of Its Phase 1 Clinical Trial in Parkinson's Disease


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"We are excited about our phase 1 clinical trial results. Patients, followed for over two years after cell transplantation, have reported, on average, improvements in a Parkinson's Disease specific measures, when compared to baseline evaluations. In this context, the results are very encouraging that the ISC-hpNSC® transplanted cells are not only well tolerated, but also may be effective" commented Dr. Russell Kern, ISCO's Executive Vice President and Chief Scientific Officer.
In terms of preliminary efficacy, where scores are compared against baseline before transplantation, we observed a potential dose-dependent response, with an apparent peak effectiveness at our middle dose. The % OFF-Time, which is the time during the day when levodopa medication is not performing optimally and PD symptoms return, decreased an average 47% from the baseline at 12 months post transplantation in cohort 2. This trend continued through 24 months where the %OFF time in the second cohort dropped by 55% from the initial reading. The same was true for % ON-Time without dyskinesia, which is the time during the day when levodopa medication is performing optimally without dyskinesia. The % ON-Time increased an average of 42% above the initial evaluation at 12 months post-transplantation in the second cohort. The %ON result improved in the second cohort to 65% above the baseline in month 24. The quality of life of the patients as measured by the Parkinson's Disease Quality of Life Score-39 (PDQ-39) Summary Index, improved 43% for the second cohort at twelve months post-transplantation. This improved to a 45% better score in cohort 2 at 48 months.