Sorry, but I just wanted to clarify a point on the primary endpoint of the trial ...
As per the trial protocol (https://clinicaltrials.gov/ct2/show/NCT02683629), the sole primary outcome measure was :
"The safety of xenotransplantation of NTCELL as measured by the incidence of adverse events related to treatment [ Time Frame: up to 26 weeks ] ".
This primary outcome has been achieved. There were no significant adverse effects.
The protocol also states that the various secondary outcomes were measured to 26 weeks and compared against the baseline .... the trial did not produce statistically significant improvements in this timeframe, which (in hindsight) was too short for the full benefits of the treatment to become apparent.
After 18 months, ""The principal investigator, Dr Barry Snow, Auckland City Hospital, says “The statistical improvement seen at 12 months has been sustained; variation between recipients is expected with the small number of subjects. The next step is further in-depth analysis to understand the data on all efficacy measurements both on and off normal symptomatic treatment.”" http://www.lctglobal.com/upload/news/2018/181102%20NTCELL%20Parkinsons%2018%20month.pdf
Looking forward to seeing the final results in June ...
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