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 Transplant Summit - Part 3

We made our way in to the larger meeting room where the actual Summit was to occur. The room was arranged with a podium beside a long table facing the audience.  There were about 300 people in the audience.  We were told that there would be people with various connections to diabetes.  There were physicians and researchers, diabetes educators, and patients and their families.




Dr. Bortz gave an introductory speech that was very compelling.  His perspective was how important this was to our health and well being and how fortunate we were to have had this option available to us. 

Dr. Hering spoke first.  He explained how islet cell transplants enable diabetics to live a healthy life both in the present and offered a much brighter future.  He had slides that showed some recent results of how complications can actualy be reversed following islet cell transplantation.  Another slide compared the difference in managing diabetes by tight control using current methods such as the pump and continuous monitor with that of transplant patients.  The difference, not surprisingly was huge.  Another slide showed the CITR (Collaborative Islet Transplant Registry) which includes data from all of the transplant centers results to that of the U. Minnesota (SDI).  I might be biased, but I wasn't surprised to see that the Minnesota results fared better.

I was the first recipient speaker.  We had decided that we would speak from our seats instead of the podium.  It was probably a good thing, because my nerves were getting to me.  Mary had to reassure me instead of vice versa which is what we had planned. 

I began by thanking the Diabetes Research and Wellness Foundation for putting this on.  We all think that this is such an important message to relate.  We are in a very unique position to be able to offer hope to people who are in need of some.  I commented on something that Dr. Bortz had said in his introduction comparing us to the miners in Chile who survived their ordeal thanks to a lifeline.  I had described my transplant several times as the feeling that I had made a miraculous escape from a place that I didn't want to be.  Then I told of how I had first seen the pig picture that led me to the Spring Point Project and then to the U. Minnesota site.  I attempted to describe the freedoms that were allowed after I no longer needed to be on insulin.  I compared my former path of controlling my diabetes with the mechanics offered by the pump and continuous monitor to the biological treatment of a transplant.  It is like the comparison of  Pinocchio and a real boy.  I feel that this is a real and complete adjustment of my body's physiology.  I tried to explain how it feels to have so much more energy.  Some of these things you really have to experience to understand.  I related that I now need to use a small dose of insulin.  I admitted that this was frustrating, but that I understand that there are no guarantees at this point.  Its just part of being treated in a clinical trial.  The important thing is that I can still control my blood sugars.  I ended by saying that if these islet cell don't last forever that I will go back to where I began and see if I can get pig islets cells after all.

Next was Mary Buche.  She is the one of us who has remained insulin independent.  She spoke of the many ways that her life has changed since her transplant in 2007.  The part that struck me the most deeply was when she said that her coworkers who knew her well could tell when her blood sugar was low even when she could not.  They would tell her to go sit down and  test her blood sugar.  When she did, it would be very low.  She also had one incident when her son had to call 911 for her when she was experiencing a severe low.  Since then, she became even more afraid of having lows to the point of keeping her BGs in the 150 range.

Dave Thoen was the third one of us to speak. He has received two islet cell transplants.  One in 2008 and the second in 2009.  He spoke of how difficult it was before the transplant because of his hypoglycemia unawareness.  He would be fine one moment and low the next.  Unfortunately, when he was very low, he would experience seizures.  During one of his lows, his 3 year old son was able to help him through it. He said that was a low point for him in dealing with his diabetes and that he remembers thinking that his son might one day have to care for him, but not at age 3!

Ellen Berty was next.  She was the only local recipient having had hers performed at the NIH Hospitals in 2001.  Her stories were of driving incidents.  She would feel a low coming on and stop her car wherever she might be.  Sometimes in the middle of the road.  The local police and paramedics who came to revive her came to know her well.  She has written a book about her transplant experience.  Its called  I Used to Have Type I Diabetes: Kiss My Islets.  If the book is as animated as she is, it will be very interesting.  I intend to find out.




Gary Kleiman had his transplant at the DRI.  He also has had two kidney transplants, one from his mother and one from his brother.  He said his family is afraid to have reunions anymore. He had his transplant at the time of his second kidney transplant in 2002.  His background with the DRI makes him very knowledgeable about the transplant process and a very credible speaker.  He also seems genuinely pleased with his results.  He is a strong diabetes research advocate.


Karla was the last speaker.  She also had her transplant at the DRI in 2005.  Her story began early in her life.  She was diagnosed at age 6.  She had one incident with a low that sent her to the emergency room where they found her blood sugar at 10.  She was very lucky to have survived that.  Hearing this also made me feel for her parents.  It must have been a constant fear for them for so many years.  She does not take any insulin at this point, but does take one unit of Byetta before breakfast and dinner.

Our stories were varied in some ways.  Different ages of onset, different drugs, different diets, and so on.  We all have different lives but have this one gigantic part that we share.  The common threads that I noticed were: physically- we had all lost weight and not gained it all back.  We all seemed to feel very lucky to have had this opportunity and very compelled to tell others about it.  We all had the highest regard for our doctors.  None of us seemed to have any serious problems with the immunosuppressants.  Our ages were similar.  We don't take any of this for granted.

A question and answer period followed our talks.   Members of the audience formed a line at a microphone and asked about what interested them.  Many of the questions were medical and Dr. Hering fielded those.  Looking at the audience, I noticed that when Dr. Hering spoke, everyone leaned in to catch every word.  He answered questions about when this might be available to everyone, about encapsulation of islets, the success rates of the transplants and many others.

The questions covered many aspects of our experiences.  People wanted to know about the drugs that we took and their side effects, about our weight, how we decided to do this, how we felt now, and more.  We answered questions that we had experience with or opinion on.  Sometimes several of us would give our thoughts on a question.  Several questions were on behalf of a family member.  Many people had never heard of islet cell transplants before the announcement of this summit.

Then it was over.  We were able to speak directly to some of the members of the audience who approached us.  I was able to exchange contact information with a few of the panelists.  I hope to establish contact with each of them. It was an incredible experience that I will never forget.  I felt extremely honored to be there for many reasons and had a wonderful time.  I wish I could go back and relive it again and am hoping that I can in part by watching the video that was recorded during the various parts of the day.  I'll post what I can here.

I'm so grateful to the Diabetes Research and Wellness Foundation for putting this summit together.  I hope that the goal of spreading this message is reached to the fullest.  I believe that doing this is an important step in reaching the cure which is what we all want.  This message might serve to encourage more people to try this option and if not, to at least have hope that the cure is within reach.  I also hope that this will encourage funding and advocacy because these things are all needed to fuel the fire that is being created by these incredible researchers.

Diabetes Transplant Summit experience Part 2

This is going to be a work in progress for awhile.  I'm still hoping to get some more pictures.  My camera must not have been set correctly during most of this. (see below).

After the TV interview and during breakfast, I was able to meet Mary Buche, a Minnesota transplant patient, and her husband Joe.  They joined Dr. Hering and me for the rest of our breakfast.  Mary and I connected immediately.  We were both so excited for the Summit and to be able to share and compare our transplant experiences with each other.  She had her transplant in 2007 and is over 3 years insulin free now.  She takes Myfortic and Prograf for immunosuppression and has no side effects other than an occasional mouth sore.


After breakfast, I joined Mary and Joe for a tour of the DC area.  We found out that you are not supposed to take pictures of the Pentagon.  A nice young police officer stopped me and watched as I very ineptly tried to delete my pictures. After all the buttons I pushed to accomplish that, its no wonder my camera was in a strange setting later for the Summit.  We also toured a botanical garden and drove around the city.  I think we got lost a few times, but neither one of us cared or was even very aware.  We were so intent on learning all that we could from and about each other.  Joe was a patient and very competent tour guide.  He seemed to just enjoy us enjoying each other.  We found that we both have the highest regard for the people at the SDI.  We both love the movie Forrest Gump.  We recognized that fountain pool from that movie.  We feel insulted when people tell us disapprovingly how thin we are.  We take our diet and exercise seriously.  We are both health care professionals.  She is a nurse, me a medical technologist.  We agree that having this background helps us to understand the process and to communicate with the transplant staff.

When we returned to the Marriott hotel, we sat outside to worship the sun and have a diet Coke. It was a nice sunny and warm afternoon.  When we went inside, Dave Thoen was just arriving.  He is the other Minnesota patient.  I had met Dave before and was looking forward to seeing him again.  We correspond through email and I really appreciate having him to consult with.  We are in the same transplant protocol and our experiences are very similar.  He has had two transplants and is currently taking just 2 units of Lantus.  We both started back on insulin at about the same time. He was able to tolerate the Cellcept, and is still taking that and Prograf.  Dave and Mary both live in Minneapolis.  I'm hoping that we can get together again while I am up there for a future clinic visit.

I went back to my room and found a message telling me that they are ready to start the individual interviews.  I quickly changed and went to the lobby to find out about this.  The interview was fairly casual.  It was a one on one with questions about my experience.  Many of them covered topics that I was planning on talking about during my turn during the Summit.  One of the questions was about what it was like being in a clinical trial. I had intended to discuss this later, but my nerves made me forget this part.  So I was glad that I had a chance to say how much I enjoyed feeling like an important part of the research team and how well taken care of I was.  I'm really hoping to get a copy of all of these interviews.  I think we were all asked the same questions and it will be interesting to see how we compare.

The other recipients began to arrive for the interviews.  I met Karla Edge first.  She is a patient from the DRI in Miami and had her transplant in 2005.  She takes one unit of Byetta before breakfast and supper, but is otherwise insulin free.  I loved her southern accent.  She has been diabetic since she was 6 and is extremely pleased with hew new life.  Next, I met Gary Kleiman.  He had his transplant at the DRI as well.  He also had two kidney transplants and has been on immunosuppressants for most of his life.  He is the Executive Director of Medical Development at the DRI.  He is very knowledgeable about research toward the cure and I'm already looking forward to some discussions with him about this.  We were all gathered in a hallway and kept having to be shushed while the last interviews were being recorded nearby.  It was just so exciting to all be together.  Except for posing for a few pictures, we were left to ourselves for awhile.  I think it was quite obvious to those around us how important this time was to each of us.  This poster was in the hallway.

We were summoned into one of the banquet rooms where the Meet and Greet was to occur.  Here we all met Ellen Berty.  She had her transplant at the NIH in 2001.  She was insulin free for a few years, but now takes a small dose of insulin every day.  She was the farthest post-transplant of us all.  I enjoyed meeting her husband as well.  He was a psychologist and was interested in the behavior of people who were experiencing low blood sugar.  He says that there seem to be parallels between low blood sugar and lower IQ.  I told him that I always felt like my IQ was probably about the same as my blood sugar at low levels.  If only this was true at the higher levels!  During this time, we were able to gather together and to meet other interesting people who were involved in the Summit and diabetes research.  It all went  so fast.  Mary and I had determined that a glass of wine would be of benefit before we gave our talks at the Summit part.  Unfortunately, I lost mine somewhere in my travels.

We gathered into various groups for pictures.  And then we went into the large banquet room to prepare for the Summit.

The six islet cell recipients on the left.






The Diabetes Research and Wellness Foundation staff with the recipients, family members, and Drs. Hering and Bortz below.

Islets and Insuln

I have been taking insulin for about a month now.  I began with the Lantus and then added some Novolog before meals.  My dose seems to be holding steady at 5u of Lantus/day and 1u of Novolog before each meal.  The combination seems to be working well.  My numbers have been really good.  I have been about 100 before breakfast and my postprandials are under 180 and many are in the 120-130 range.

After the initial few doses of the Novolog, I stopped getting that tired feeling.  It has only happened one other time since. It was on a day when my post breakfast reading was 108.  Its a lot like the old days when I would see a reading in that range and know I might be in trouble.

At my recent visit, my endo added a C-peptide to my tests to see how that was faring.  It was 0.34 which is low.  I wondered if the insulin that I now take might have an effect on that reading and e-mailed Janet and Dr. Bellin with that question.  The answer was that yes it does.  It makes sense that my islets would not need to work as hard now that they are supplemented with the insulin.  I hope that they are enjoying this rest and are using this time to regroup or regenerate or recuperate or whatever it is that they are needing to do.

I'm getting myself prepared for the Diabetes Transplant Summit.  My involvement has progressed.  Now I'm going to do an interview that morning along with Dr. Hering on one of the local stations.  I get overwhelmed just thinking about it, but what an opportunity.  For the chance to stand beside my hero and talk about something that I feel so strongly about, I can withstand a few butterflies.

On the research front, the Sernova corp. has signed on Dr. Shapiro of the Edmonton Protocol and more recently Dr. Sutherland from U. Minnesota.  This is the islet sheet project where a pouch containing islet cells is implanted in the person and is permeable to glucose and insulin, but not to antibodies that would destroy it.  This means that no immunosuppression is necessary and it is replaceable if/when the islets give out.  And they use pig islet cells!

We had a good time carving these.