Not yet, but there are plans to have an Insitute in the late-summer of fall of 2009.

If anyone would like more information about the Institute, then the link is in my post above.

During yesterday's MJFF research forum Dr. Kordower answered a question about the use of sham surgery in gene therapy trials.. He mentioned that it passed the "Mom" test. Said if his mom was going to be in a clinical trial utilizing sham surgery, he would actually prefer that she be in the control group and receive the placebo (sham surgery) first. If the treatment were proven safe and effective, the control group could then receive it as part of an open label study, with less risk. Wondering if this option will be offered to the participants who received sham surgery in the CERE-120 trial, if Ceregene does go ahead with further trials?

Just remembered that sham surgery patients have received the treatment -because i have a friend in the original canadian fetal transplant trial - Lynda Mckenzie. We met in an obscure, underground ICQ chat room 10 years ago -the only ones that appeared. How could I forget this? She was being followed by a tv program [like Frontline or maybe it even was]...like a Canadian 60 Minutes.

She got the placebo and it took two years but she did get the treatment. She said she would do it all over again.

She has since had a DBS, and she visited last winter. SHe looks younger than me [we are close in age] and is doing better....for awhile she was very dyskinetic.

She is a very brave lady...quite exceptional.

paula

Paula, I do want to reply to post #53, but I have to go to bed. I have a meeting at 9am and I have never met these folks before and am walking into something that has been ongoing for a while and I need to be alert.

So, I will come back in the afternoon tomorrow and reply.

You really thought out these questions about gene therapy, didn't you? They are quite good, I might add.

Having participated in a trial that required transplanting retinal cells into the brain, I;d like to comment on some things you brought up:

You asked:
Have sham surgery participants ever been given a pd treatment at trial's end?

The only case that I can think of is the fetal tissue trials (our friend Lynda from Canada was one who had sham surgery, then received the cells after not knowing if she did or did not get the "real thing." ) I wish she would come back to talk with us. Her online name was Mischef. It seems there was a year or so between sham surgery and getting the cells.

As many of you already know, the fetal cell trials were dropped because they could not control the reproducing or growth of the cells. The patients got too much of a good thing and suffered with horrible dyskinesaias. I believe Miischef has had DBS since then and is doing better.

You asked:
Does their informed consent wording have a loophole that easily excludes sham surgery participants?

Not exactly, but most say something like "IF the treatment is found to be safe and effective" those having sham surgery will be given the opportunity to have the real surgery. That's a might big IF in my opinion!

You asked:
How much weight is given to the stress, anxiety,and depression that accompanies sham surgery knowing that the treatment is possibly going to work or has worked for some?

I believe more attention should be given to this point you make, but Mischef's story puts a different twist to the emotional stress. I recall and even have the video made of Mischef's story of having the sham vs the real surgery. (It's on an old VHS tape. I'll try to drag it out and get it converted). I remember the video showing Mischef and her family waiting around the phone for the call after the results were made known. Her symptoms had worsened and if she had gotten the real cells, that would have meant that the fetal cells were NOT producing dopamine. It was a very emotional time for her and her family, and they were so relieved when she was told she had sham surgery. Then as I said before, she did get the real thing a year or so later.

There are other questions or comments you have made that I'd like to discuss, but it's almosto midnight and (yawn) I'll have to address them later.

Thanks for this thread.
Peg

Lynda McKenzie very generously contributed her account of her experiences in the fetal cell transplant trial to a book i co-edited, "When Parkinson's Strikes Early. " You can read these sections from the book on Amazon.com. Search for the title. Then click on "Look Inside" and search for the word Lynda. Her story is mostly on pp. 178-84

She initially had the sham surgery, and although she felt some improvement at first, it only lasted about 4 months and could bbe a placebo effect. The difference is with some of the more recent studies, such as GDNF, some doctors said improvements that trial participants said lasted 3 and 4 years may also have been a placebo effect. Is this really possible? This question needs to be answered.
Lynda received the real treatment about 2 years later.
Lynda is a naturally upbeat, positive and optimistic person. She didn't believe the study was a "failure" because we learned so much from it. At the time she said she would do it all over again.

Thanks, Linda. I knew I had read this somewhere other than just seeing the video. Wouldn't a study in attitude and length of placebo effect be interesting? I thik we need to go back to the Biofeedback and psychological counseling days. (I feel that if I did the study, however, it would be very biased with skewed results, because ATTITUDE IS EVERYTHING!)

Peg

Does the sham surgery really make the trial blind? Did the patients who got the sham in the CERE trial have the exact physical reaction(s) (severe facial & eye swelling, etc) as those whose brains were invaded by the treatment?

If theír physical reactions were milder, then wouldn't the treating doctors & nurses see that and come to the obvious conclusion that they didn't get the real treatment?

Just wondering... how can we find out?

Jean, you have an excellent question. I would have to say NO to the swelling. But I don't know that any of the patients were told to expect facial swelling. I was not told to anticipate swelling of any degree, especially the amount of swelling I had.

I feel that if the participants in CERE had been told to expect swelling there that this would have pretty much unblinded the trial.

Because I lost those first 10 days and have never regained my memory of them, I only know how my face appeared the first day I have a memory of and that was day 11. And it was still swollen when I looked in the mirror that first day, but I was recognizable by Day 11.

I understand from family that my face was extremely swollen. Hence, just one more indication that I had the real "thing".

My first 30 days begs the question, how did that period of time effect me over the next 11 months post surgery? I still am not sure, but I have my thoughts on the topic.