Islet Cell Transplant study completed - the good news/bad news

As I mentioned in my previous post, the islet cell transplant study that has been ongoing for several years has been completed.  The centers who make up the Clinical Islet Transplant Consortium have transplanted the needed 48 patients and now the study is closed.  That is certainly the good news.  It is a great coup for all the scientists and staff who have worked so hard to get this accomplished.  The data will be collected and submitted to the FDA for approval.  WHEN this occurs, islet cell transplants will become standard treatment for diabetics who can benefit from this type of intervention.  Of course, insurance coverage will be another battle, but thats a separate topic.  The estimated date is 2013, which is just amazing.  I'm going to look into the possibility of pelting the FDA with success stories from the islet cell transplant patients that I have met.  I don't think I would have to twist any arms to get them.  We're a very happy group.

So, how could there be any bad side to this?  Its the human element.  The patients who have invested their time, money, and most importantly their hopes in the process of qualifying for an islet cell transplant, only to get a call saying that the program is over/closed.  There are several on the Pancreatic Islet Cell Recipients facebook page.  My heart really goes out to them.  I would have been devastated to have received one of those calls after I had been waiting for THE call.  I know this is an unavoidable situation in the process, but I need to recognize it.  Its really hit me hard.

the Senator at 10 months

It sounds like there might be some hope for getting a transplant before they are made available to the public.  During the Transplant Symposium, Dr. Hering mentioned that through a program called "expanded access", patients with more extreme need, may be able to receive a transplant.   The webcast from the Transplant Symposium is available now and here is the link.  He talks about the process of the trial, submission to the FDA, and this expanded access possibility at about 1:18min. into the program.  Its very heartwarming to see him smile when the applause erupts about the possibilities he has created

I also asked what the patients at the SDI are being told when they get the calls as to what they can do.  It seems that the clinical trials.gov  site is a good place to search for any current islet cell transplant trials.  At the SDI, they are not enrolling for current transplant studies, but will hold a patient's information for use in any future trials.  Also, they are still performing islet cell after kidney transplants.The webcast, like the Symposium itself is very interesting and fun to watch.  I noticed a few things that I had missed the first time.  It is a very upbeat and informative session.  I still have yet to read anything on line as to the completion of the transplant trials.  I'm disappointed in my google alerts and in the lack of any press of this monumental achievement.

Diabetes Symposium experience

The recipients and a diabetes alert dog

The Diabetes Symposium was held in Minneapolis on Tuesday evening.  It was an exciting and emotional experience for me.  I'm still waiting for the video of the session to be released, and will post it when it becomes available.  The Minnesota Medical Foundation has a link to Fox News and parts of the program here.

I arrived in Minneapolis on Tuesday afternoon.  My friend, Camille, picked my up at the airport and I stayed with her while I was there.  Spending time with her and her husband Geoff, was a very nice part of my trip.

The Symposium was held at the Best Buy headquarters. A local Fox reporter who is a Type 1 diabetic was the MC.  Richard Schulze is the founder of Best Buy and a huge supporter of diabetes research.  The Schulze Diabetes Institute is named for him.  It was an impressive building (lots of blue).  Just as we arrived, Janet, my retired nurse coordinator walked in.  I was able to sit with her and chat before the program began which was an added bonus.  There were about 450 people who attended the event and it had to spill over into an auxiliary room.

There were a few surprises in store for me.  Inside the folder that we were given as we walked in was the story that the Diabetes Research and Wellness Foundation did about my transplant as well as the nice picture of Dr. Hering and me.  I was just getting over that surprise when the program began.  It started with the video of the interview that Dr. Hering and I did in Washington DC at the previous Diabetes Summit.  That was a shock to see in larger than life form as well!

The format of the program was for the eight recipients to tell of their experiences with diabetes both before and after the transplant.  Its getting very difficult for me to hear those before stories.  It brings back so many uncomfortable memories of my seemingly previous life.  In addition, there were questions that people had submitted  on line as well as some live questions for the patients and Dr. Hering.

One of the highlights of the evening for me was when Dr Hering answered a question about when islet cell transplants might be available for everyone.  He began to tell of how the main transplant study was just completed last week which involved the centers in the Clinical Islet Transplant Consortium.   They had transplanted the targeted number of recipients and that the trial was closed except for collecting the data from the more recent transplant recipients.  In a year, when all the data is completed, it will be submitted to the FDA for approval.  If/When the FDA approves it, it will become available.  He projected that as happening in 2013.  I'm not sure how the insurance coverage will work with that.  I'm guessing that that will be another battle.  But, it is a giant step in the right direction.

Another issue that Dr. Hering spoke of is the fact that so many people see the immunosuppression as a deal breaker in having an islet cell transplant.  He gave his views on this which are that he doesn't feel that this should be the case.  The immunosuppression isn't perfect, but it is less problematic than uncontrolled diabetes.  I hope that many people will hear this message.  Its the most common question I hear or read about the procedure.

The recipients ranged from about 6 months post-transplant to 10 years.  Most were insulin free.  Greg had his diabetes service dog with him which was very interesting to me.  He told of how the dog saved his life at least once by alerting him of a low.  Melissa stated how she never realized how sick she was until after the transplant when she was able to feel so good and healthy.  Most had stories that involved the paramedics and some had experienced seizures.  One of the questions that was answered by each person was whether they would do this again.  It was a unanimous "yes".  Another common thread was of the families' involvement with the disease.  Many had to rely on their children to understand the limitations of their parents and to have to physically help them at times.  Having lows at work and having to depend on the assistance of coworkers was something mentioned by several people.  All of them suffered with hypoglycemia unawareness.

All of the recipients and doctors

I had a different perspective for this Symposium as a member of the audience.  I couldn't help thinking about the people that I was sitting with and wondering what they must be feeling.  I worry that the parents of diabetics, like Camille, feel very sad when they hear how much better the daily lives are of the patients after the transplant.  It must seem so unfair to think that your child is suffering with this disease with no immediate relief available.  I think of the other adult Type 1s who can hear how wonderful it is to be free of the worry of having lows.  Its probably very difficult to even imagine and, as I remember, almost painful to hope for.  I know thats why everyone is here, but what is being offered here is not something they can physically take home with them.  I think it was probably hard to turn around and walk out the door leaving all of this behind.

I hope that hearing all of these stories was very rewarding to the doctors and staff of the SDI.  I don't think that they can hear often enough what an impact their work has on the lives of their patients.

I didn't attempt to summarize the stories of the recipients.  I will post the video when it becomes available so that people can hear for themselves.  They were all very moving.  I don't think there were many dry eyes in the place.