Parkinson's Clinical Trial Yields Positive Interim Results.
All patients in the first cohort who are receiving 30 million ISC-hpNSC cells are meeting the primary endpoint, which is safely.
The relatively small sample size makes it difficult to observe statistically significant differences, the interim efficacy results are very encouraging, the company said.
The first dose tested was used to determine the safely and tolerability of ISC-hpNSC therapy and is below the optimal therapeutic dose established in our preclinical studies.
The company anticipates strong results in the second cohort (receiving a higher dose of cells) in which two patients have been treated already.
These clinical results build a strong foundation to start Phase 2 clinical trials in PD and traumatic brain injury.
The percent OFF-Time, which is the time of day when levodopa medication is not performing optimally and PD symptoms return, decreased an average of 24 percent for the first cohort at six months post-transplantation.
The percent ON-Time without dyskinesia, which is the time of day when levodopa medication is performing optimally without dyskinesia, increased an average of 19 percent for the first cohort during the same period.
One hundred percent of the patients improved their mood six months post-transplantation with an average improvement of 35 percent in the Beck Depression Inventory and 33 percent in the Emotional Wellbeing dimension of the Parkinson's Disease Quality of Life Score-39 (PDQ-39).
All (100 percent) patients improved or retained the same cognitive abilities with an average improvement of 14 percent in the Cognitive Impairment dimension of the PDQ-39.
Conducting routine daily activities seemed easier after six months as demonstrated by the average improvements of 22 percent in Activities of Daily Living and 15 percent in Mobility dimensions of PDQ-39.
The Bodily Discomfort dimension of PDQ-39 also improved an average of 12 percent after six months. The Unified Parkinson's Disease Rating Scale in the OFF period did not improve six months post-transplantation.
Impulsive and compulsive disorders were diminished, as demonstrated by the 53 percent reduction in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease.
No test article related serious adverse events have been reported in the clinical trial. There is no evidence of tumors, cysts, enhanced inflammation or infection.
No Human Leukocyte Antigen antibodies against the implanted ISC-hpNSC have been detected.
The Phase 1 clinical study is a dose-escalation safely and preliminary efficacy study of ISC-hpNSC, intracranially transplanted into 12 patients who have moderate-to-severe Parkinson's disease.
The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30 million to 70 million neural cells.
Following transplantation, the patients are to be monitored for 12 months at specified intervals to evaluate the safely and biologic activity of ISC-hpNSC.
ISCO's proprietary ISC-hpNSC consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells.
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|Title Annotation:||In The Clinic|
|Publication:||Stem Cell Research News|
|Article Type:||Clinical report|
|Date:||Nov 20, 2017|
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