Qualifying For A Clinical Trial
Posted 11 April 2007 - 07:45 AM
Posted 11 April 2007 - 12:45 PM
I'm sure one of the few who have qualified can provide more insight to your question, but I know that I was disqualified from the SCOT Trial due to my pacemaker. I found this out by emailing the "contact us" person on their main page. I received a very nice email back stating my automatic disqualification. It save me a lot of time. I'm sure you could get your question answered in the same manner.
Please let us know what you find out.
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Posted 11 April 2007 - 02:08 PM
I have actually been in a few studies as well as disqualified for a few. The one's that I was disqualified from where because I have had sclero too long. The studies alll stated "date of diagnosis must be no more than X years". I am always way more than the "X"!
Hope this helps!
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Posted 11 April 2007 - 03:34 PM
The clinical trials for the stem cell transplants have the following:
If you want to participate in the SCOT trial ANY use of Oral cytoxan will disqualify you. Similarly more than 3 doses of Cytoxan IV will disqualify you. And your skin score needs to be a certain amount -- I think 15 is the minimum.
For the ASIST trial at Northwestern, there is no disqualification for cytoxan usage and they have removed the skin involvement score if you have internal organ involvement.
Both studies will disqualify you if your heart is not in great condition as the SCT procedure itself is very taxing on the heart due to the medications given.
Hope this helps. Gidget
Posted 17 April 2007 - 04:04 AM
Posted 18 April 2007 - 07:04 AM
I am waiting to hear if I've qualified for the SCOT trial. The minimum skin score to participate is 16, mine was 26. I am also an ex-smoker. They want active people with sclero to participate especially since the stem cell and high-dose cytoxan are so hard on the body.
MUSC doctor told me that I was a good candidate but that he wanted to see me off of the pain meds and to get rid of the cane. I use the cane for balance not necessarily because I can't walk. You have to have been diagnosed within the last 5 years and have diffuse sclero with organ involvement. In other words, your condition has to be bad enough to be considered because the risks are so great. That' the bad news, the good news is that both treatments are considered to be worth the risk. My prognosis with regular treatments and care is 50% for 5 years. They will consider that as well. What they didn't tell me is that the trial is to track organ damage at 44 months as well as set the Standard of Care for people like me.
If I don't make this trial, I will definately look for something else. Hopefully, all of us can find something to supress our conditions since there is no cure.
Posted 18 April 2007 - 08:49 AM
I have had diffuse scleroderma for 5 years and iam currently on plaquenil and pariet. I have only been on these drugs and prednisone. Do you think I would qualify for the scot? I'am 26 years old and my oirgans aren't affected, may be slightly on lungs, not sure if fibrosis on lungs or acid?
Posted 18 April 2007 - 08:51 AM
Has anyone heard of IVIG and it's affects with scleroderma? My sister has Lupus and went on this for 18months and has been in remission for 5 years now.
Posted 19 April 2007 - 01:06 PM
I would try if I were you. If you are in relatively good health- do it now. The SCOT trials have a time limit and you need to have a minimum 16 on your skin score. Call them, this site has listings of open trials- but I don't know where it is off hand.
I have heard of IVIG, but don't know of any trials that are studying this method. If you find out let me know please! If I don't make this study, will try Northwestern, if I don't make that - I'll try somewhere else.
Sounds like your progression is fairly slow is this correct? My was fast and aggressive. Diagnosed Jan. 4, '07 and have total body skin involvment, lung, heart & Kidney (mild) and esophogus (sp?).
Take Care - TJ
Posted 02 May 2007 - 04:52 AM
I just had my translant 3 weeks ago and I am doing great. I know there is a link to my blog here somewhere.
I realize that both trials have some of the BEST of the BEST doctors behind them, but after going thru both screenings and talking EXTENSIVELY with docotors on both sides, I feel that I absolutely made the right decision for myself.
Feel free to contact me if you have any questions. It is a difficult decision to make. I am 39 and I have 2 small children. I had minimal skin involvement-a score of 16 and my DLCO was at 43%. I wanted to nip this thing in the bud and not wait around until I was knoking at death's door. I choose not to try other medications first and to just GO FOR IT! It hasn't been an easy road, but it has definitely been the right road.
Posted 02 May 2007 - 05:49 AM
Thanks for posting this and updating us all on what is going on with you. I am so happy to hear that the transplant went well and you are doing great! That is such awesome news! I am sure this was such a hard decision for you, and it is great to hear that you believe you made the right decision at this point. Please do keep us updated on your progress.