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xpsychiatricmd, it's so interesting to read about the beginnings of your Tcelna trial experiences. Please keep posting updates, a lot of us are excited about these kinds of novel therapies, so keep the updates coming thick and fast! Are you seeing a change in symptoms?

Hello vikingquest,
Thank you for your encouraging words. I have only received two treatments, so there are no noticeable changes. This is not surprising since we don't even know if I got the Tcelna and not the placebo. It would be great if others in the Abilit-T trial would post so that experiences could be compared. I don't know why Opexa or the FDA went for the double-blind placebo when they were previously doing an open label trial when funding dried up. One of the things evident from the TERMS trial was that Tovaxin or Tcelna for that matter, has no significant side effects. Although in that trial Tovaxin did not statistically separated from placebo, it has been mentioned that the randomizing did not provided a fair assessment of the drug.

Well, I am scheduled for the third treatment next April. I feel that there hasn't been any improvement even slightly, yet you may say that the MS continues to progress. I made a decision to withdraw from the study. Perhaps, I would be more patient if assured that I was receiving the real product This is done in spite of having pursued the trial quite activelyl. I don't know what I was thinking when I made my mind to go forward. No more double blind placebo studies for me. Although there are no treatments of value in SPMS ( Novantrone has many problems ), I can't get involved on trials without an assurance that they can work. In order to be effective, you have to receive the product and not placebo. Back to steroids or wait for BG12 when it gets out.

xpsychiatricmd wrote:I made a decision to withdraw from the study. ... Back to steroids or wait for BG12 when it gets out.

Was there a specific restriction in being part of the trial? or was it the hassle of the trial itself with no guarantees?

No, there were no restrictions other than having to adandon the previous MS therapy. I was on Rebif and every 2 months or so IV solumedrol. I was offered Acthar by the neurologist, but I decided to seek the Tcelna trial. The second question is more like it...no guarantees.

Were you allowed to continue with a supplement regimen while in the trial? If so, could this be freely modified, i.e., try out a new supplement or discontinue an old one?

Thanks, NHE

Supplements were not restricted. The supplements that I was taken are D3, Ocean Blue (Omega 3), Multivitamins (Centrum Silver), B complex, B12 sublingual, Citrocal, in addition to lisinopril and baby aspirin.

Wow. You were allowed to stay on lisinopril?! That's wild! It's in trial for ms.

They followed the trial protocole to the T! If desired, refer to the trial at ClinicalTrials.gov under Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis (Abiliy-T). Sorry that I can't provide the link.

From the exclusions:

Previous treatment with any other investigational drug 1 year prior to screening

Uh...do they not know lisinopril is in trial? I think it's for rrms but still!

I knew of the statins being looked at but not of lisinopril. I have been on it for many years, only 5mgs though. It hasn't improved the course of my disease. Following the post, I found out that lisinopril is being looked at MS in mice. Anyway, it's not relevant to me now since I quit the study. Thanks for the info.

Nope. It's being studied in Pwms. http://m.prnewswire.com/news-releases/t ... 06903.html I thought the "study people" would be aware, not you!

I'm not surprised it isn't helping you. It loses control of aldosterone a couple of months into therapy...and probably wouldn't help spms anyway.

Hope your next treatment choice proves more successful.

Thanks for the link and concerns, Anonymoose. I had spoken on the phone with a research neurologist, who knows my brother, before the trial who was more positive for BG12. Any thoughs?

http://en.m.wikipedia.org/wiki/Dimethyl ... #section_4

Dimethyl fumarate is a lipophilic, highly mobile molecule in human tissue. As a α,β-unsaturated electrophilic compound, dimethyl fumarate is rapidly attacked by the detoxifying agent glutathione (GSH) in a Michael addition reaction.[9][10][11] Dimethyl fumarate is highly reactive: when administered orally, it does not survive long enough to be absorbed into blood without being attacked by GSH. However, part of it is hydrolyzed by esterases to produce monomethylfumarate, which is more resistant.[12] GSH depletion and subsequent induction of the anti-inflammatory stress protein HO-1 is thought to be one of the mechanisms responsible for the immunomodulatory actions of DMF.[13]

The EU Commission Decision 2009/251 of 17 March 2009 requiring Member States to ensure that products containing the biocide dimethylfumarate are not placed or made available on the market has definitely forbidden any marketing of products containing dimethyl fumarate into the European Union.[45] The ban on dimethyl fumarate as laid down in Decision 2009/251 establishes a maximum concentration of dimethyl fumarate in products of 0.1 ppm. Products containing more than 0.1 ppm dimethyl fumarate shall be withdrawn from the market and recalled by consumers as of 1 May 2009.

BG12? I think it's poison. It helps by depleting our bodies of a natural detoxifying agent to induce an anti-inflammatory reaction. I wonder what wonderful long term side effects this will have. You won't suffer too much from MS but you get cancer or some other horrid disease instead? Sorry to be a Debbie downer but how could you not be looking at that info?! I think something better is on the horizon.

Thanks!