Actually just to remind investors the primary end point is "safety" so it will definitely be "successful". The secondary end points though are the real points of interest.
Primary Outcome Measures:
The safety of xenotransplantation of NTCELL as measured by the incidence of adverse events related to treatment [ Time Frame: up to 26 weeks ]
Adverse events can result from, for example, abnormal clinical laboratory tests (including xenogeneic viral analysis), abnormal physical examination findings, any abnormal findings following review by an infectious disease physician. These multiple assessments result in the one outcome measure which is the incidence of treatment emergent adverse events
Secondary Outcome Measures:
Change in total Unified Parkinson's Disease Rating Scale (UPDRS in the 'off' and 'on' state) over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III in the 'on' state) over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
Change in Quality of life as assessed by Parkinson's Disease Questionnaire (PDQ-39) over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
Change in L-dopa dosage over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
Change in scores measured by the Unified Dyskinesia Rating Scale (UDysRS Parts I, II, III, IV - Parts III and IV will be performed in the 'off' and 'on' state) over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
Change in scores measured by the modified walking test in accordance with the CAPSIT-PD protocol (Defer et al. 1999) over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
Change in Modified Hoehn and Yahr stage over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
Estimated Enrollment:
18
1
Study Start Date:
February 2016
2
Estimated Study Completion Date:
February 2017
3
Estimated Primary Completion Date:
February 2017 (Final data collection date for primary outcome measure)
LCT Price at posting:
11.0¢ Sentiment: Buy Disclosure: Held
(20min delay)