question about how placebo would work for stem cell trial

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Kristina1

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The neurologist told me that a trial for BrainStorm/NurOwn stem cell therapy would be starting in my area soon. She mentioned there would be a placebo group though. I don't understand how that would work. If you end up assigned to the placebo group are they seriously going to remove your bone marrow for no reason and then inject saline into your spine? It seems really invasive for the sake of having placebo group data.
 

Nikki J

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Yes that is my understanding. I wonder if they could roll in an extraction of spinal fluid for biomarker research? In a spirit of while I'm there? There are plenty of us who have had spinal taps purely for research and it has yielded some important information

But to go back to the question. How else can they do it? and presumably the researchers are blinded so they do not know either. The FDA usually insists on placebo groups
 

Kristina1

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I just feel like if they are going to put you through having your bone marrow extracted they should give you the real thing! I hope they at least will store it for you for future use or something.
 

Nikki J

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They might I suppose. There could also be an open label extension where everyone gets the real thing. That is happening with 2 current trials including the sod1 gene blocking where people have had multiple spinal taps and some are in a placebo group. You would not know that at the start though.

While we all hope for a clinical trial that helps ( and so do our doctors) the purpose is, of course, advancement of knowledge and the consent forms reflect that.
 

lgelb

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Yes, the placebo group does have to undergo "administration" of an excipient in the same manner as the treatment group, as has been the case in other trials. Otherwise, it's not blinded.
 

GregK

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many people object to the use of placebos, but they are unfortunatly a necessity.
 
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