Pluristem Therapeutics Inc (PSTI)

[HappyBee]

Hello Scott, in response to your question I may have a partial answer. I am having difficulty posting a link, but if you go on Pluristem’s website and click on ‘Clinical Programs’, then further click on ‘Clinical Limb Ischemia (CLI)’, you will find more detailed information regarding the Phase I/II/III trials for this indication.

It appears that Phase I/II was conducted ‘open label’ and that Phase III is conducted ‘double-blind’.
Regarding the terms ‘open-label’ and ‘double-blind’, this definition is from the website Medicinenet:

‘Open-label is a term used to describe the situation when both the researcher and the participant in a research study know the treatment they are receiving. Open-label is the opposite of double-blind when neither the researcher nor participant know what treatment the participant is receiving.’

It is my understanding that a double-blind trial has to be fully completed before anybody knows the full results, but reading the information below (contained in the detailed information referred to above) may suggest a possible exception in this case.

‘Our clinical development program for PLX-PAD in CLI was selected for Europe’s Adaptive Pathways pilot project. This program may allow for an interim analysis of efficacy following data from 50% of the patients (n=123), in support of an application to the EMA for Conditional Marketing Authorization (CMA), a significant opportunity to bring PLX-PAD more quickly to patients suffering from CLI.’