3. THAT RANDOMIZED CONTROLLED STUDIES WERE ALREADY UNDERWAY IN BUFFALO. ANYONE KNOW ABOUT THAT?
It's a small study of 30 patients. First ten are getting the treatment as a safety/pilot twenty. Of the next twenty, half will get the treatment and half will get placebo. I don't know how 'underway' it currently is.
I cannot believe this. But it'll be ok. You cannot keep a good doctor down.
People are starting to get contacted and scheduled for this. But they MUST be on DMDs or they are disqualified from the study!!!!
This is true. I am in Buffalo and was contacted yesterday to be in the first cohort of 10 people to receive testing (to be conducted today and tomorrow) and, if positive for CCSVI, receive treatment next Wednesday.
I was disqualified because I do not take any disease modifying drugs (DMDs). It was mentioned that 5 others preceding me were disqualified for the same reason.
I was told that the first cohort of 10 were to prove the safety of the procedure. The second cohort of 20 would have a 50% chance of actually receiving angioplasty. The other half would receive a sham procedure.
I would not have had to pay for any of this were I able to participate.
At this time, this is the only treatment study the BNAC is doing. All of their other studies are for imaging. The results from the first study of 500 were released this spring. The primary current study will ultimately have 1,700 people and I participated in this in April. That's a blind study, the results are not given to participants and I did not pay for it.
Another study is the self-funded study. For this, they are charging $4,300 for a set of tests (more than just MRv and Doppler ultrasound) and a clinical visit, in which the results are given. However, they require you to sign a legal disclaimer that states "any information you gain from these Tests is purely informational and educational and will not be able to be used by you or any other person to diagnose, cure, treat, mitigate, or prevent your MS." I'd have to say that's just a CYA because they know darned well what people will do with their positive results.
I am so very sorry to hear that Dr. Sclafani did not get IRB approval. It makes no sense. I will offer to help in any way I can with finding a facility that will support Dr. Sclafani and assist with fundraising.