Adacolumn

My guess would be because it's a very invasive procedure and could potentially expose us to all sorts of pathogenic organisms.

Dialysis also isn't "simple." It requires people to maintain a port for the dialysis (putting them at risk for septicemia.) It is time-consuming and expensive. It has caused infection issues in the past and well could again. Did you know that 20 years ago, nearly 100% of dialysis patients had become HIV positive because at the time the transmission wasn't as well known? Finally, long-term dialysis is known to cause mental deterioration in many people. They tend to become much like dememtia patients, with poor memories and poor emotional control.

Maybe that's why we're not doing this.

The Adacolumn is approved for use in Japan. Adacolumn Apheresis phase 3 studies for UC in North America ended a few years ago. I participated in the study hear in Toronto. I had 12 treatments in the first part of the study and later found out that I had the placebo. I then went on the open label (actual treatment) and had another 17 treatments with no improvement in symptoms. When the study was over I received a letter telling me I was on the placebo and that the effectiveness of the treatment compared to the placebo was only slightly better and as a result the treatment will not be approved for use in Canada and the US.

After talking to my GI about it he gave me several reasons why the study may not have worked out in North America but was fine in Japan.

1. UC in Japan may be slightly different then in North America.

2. The Adacolumns were manufactured in the US and may be slightly different than in Japan.

3. The Testing in North America may be more rigorous.

My GI said if they do find a reason they may correct it if possible and conduct more studies in North America.

The North American Phase 3 studies for both UC and CD are closed. The study was a long process for me. A few times I thought my symptoms were improving but latter they would get worse, the normal ups and downs with this disease. I had the treatment twice a week for the first 2 weeks and once a week after that for both the placebo and the actual treatment. It was very time consuming. My blood was pumped from my right arm through the Adacolumn and back to my left arm. The needle in my right arm was slightly larger and a little more painful when inserted. I had 3 different nurses that hooked me up and one was much better than the other 2. Each treatment would take one hour. I never felt anything unusual with any of the treatments. Once in a while the machine would alarm because the blood flow was low or had stopped. The nurse would then take a syringe of saline and flush out the needles in my arm. During one treatment the blood in the lines and the Adacolumn completely gelled and would not flow. The nurse then called the doctor and a representative from the study about it. Since I completed more than half of that treatment they stopped it and said it was long enough. Less than half and I would have had to repeat it with a new Adacolumn. I lost all the blood in the lines and the Adacolumn but didn’t feel any different from it. During the treatment I either slept or watched a DVD.

Isnt this the treatment for UC in States??