Recruitment for the SCUlpTOR trial has now officially closed:
https://kollinginstitute.org.au/sculptor-study
The finally patient numbers may or may not be updated on here at some stage at USYD's discretion:
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379726&isReview=true
With the primary outcome and 33 of the 34 secondary outcomes containing data points 24 months after the first injection and Professor Hunter stressing on the need for "high-quality trials like this one to produce the evidence" "with the potential to informclinical practice guidelines globally", I am now convinced that we won't see any data or get any indication on how the patients are progressing at any of the various data points, to avoid the risk of bias in any shape or form.
+ the trial has finished recruitment with patient numbers that provide sufficient statistical power
+ no further costs for Cynata in the form of providing cells
+ no adverse events reported, hence adding to the safety profile of the cells
- likely 24 months plus "x" for the results to be released, either via a Clinical Study Report and/or in combination with presentations
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Ann: Phase 3 Osteoarthritis Clinical Trial Commences, page-391
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