Saturday, October 8, 2011

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  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.

1 comment:

Dianne Mulholland said...

At our house it was the "bad news"... After 2+ years of being #1 on the waiting list at UPENN - Chuck got the dreaded call this morning. He was given no hope what so ever by the caller (all funding pulled).
I'm keeping my fingers crossed for the approval and hoping for a sooner date as Chuck will be 65 next year.