Here are our patients who decided to come back to Chicago from different states of the US and meet together to give their testimony as well as share their experience about islet transplantation.
Over last 20 years safety and efficacy of islet transplantation for patients with Type 1 diabetes have been proven in clinical trials in the US and other countries. Consequently, the procedure became available as a standard of care and reimbursed to patients in Canada, Australia, Japan, UK, France and other European countries, but not yet in the US.
The main obstacle has been inadequate regulations of islet in the US, FDA has been considered islets as a drug in contrast to other countries, where islets are regulated as any organ/tissue for transplantation. Regulatory requirements for drug manufacturing preclude academic institutions from islets isolation beyond clinical trials on one hand. On other hand, even if drug regulations and manufacturing systems are implemented, they do not reassure quality safety and efficacy of the islet after transplantation.
Leaders in the field of transplantation and diabetes (Islet for US Collaborative) have been calling for the urgent regulatory update allowing islets to regulated as any other organ for transplantation under UNOS/OPTN oversight, however without any success (more on www.isletsforus.org)
Currently, islet transplantation can be performed in the US only in settings of clinical trials completed funded by research. Due to high cost and limited funding only few centers are actively enrolling patients in the US. The further progress in the field is impossible without amending the current regulations , so islet transplantation could be reimbursed by insurance, more patients to be treated and cost of research more affordable.
Our patients are as disappointed as we are from the current regulatory obstacles and wish that every American who experiences what they did living with diabetes, could have an access and opportunity to benefit from islet transplantation, like they did. Therefore, our patients are all happy to provide their testimony and to give hope to all those patients who failed all available means of glucose control and loss control of their lives.
These testimonies are also for physicians, who are not fully aware of possible positive impact of islet transplantation on their patient lives and do not advocate for that.
Some patients have had great outcomes with full long-term insulin independence. Others have had partial islet function, which still prevents them from severe hypoglycemic episodes, while requiring some insulin supplementation. Few patients lost their islet graft function after a while and resumed their insulin pumps. Lack of funding did not allowed for subsequent islet transplant.
However, once they experienced already benefits of insulin independence despite immunosuppression, four of our patients without hesitation requested subsequent pancreas transplantation and have been enjoying insulin independence again.
Importantly, none of patients have ever regretted going through the process of islet transplantation. Complications varied, but none of them were as life threatening or compromizing daily life as hypoglycemia unawereness with severe and unpredicted lows. Our patients again experience their joy of life and feel again being in charge of their lives fully participating socially, emotionally and professionally. It is an ultimate satisfaction and award for them.
Here are the stories of individuals with long standing, type 1 diabetes with problematic hypoglycemia, who received islet allotransplantation.
All of them suffered for years from very similar, debilitating symptoms, leading to the same beginning narrative:
....After many years of taking insulin and religiously keeping my blood sugar under
control, I gradually stopped feeling when it was low, too low. I used to get agitated, shaky, hungry and knew I needed to grab a snack... Not anymore! Now, it happens without any warning. I can't predict it. I am completely unaware when my speech starts to slur or when I am getting confused. Sometimes finding myself in unknown places, sometimes I pass out and wake up surrounded by family members, strangers or paramedics who injected glucagon. The frustrating and scary part is that I can't control it, and can't anticipate when it will happen. It may happen at night, and I am terrified that I may never wake up. My wife and children check on me several times a day and they panic when I am not picking up the phone. Not only my life, but the life of my family is badly compromised. I have been listening to my endocrinologists, trying several different settings on my pump a day and more at night but still lows happen.
The only thing I can do, is to run my glucose high when I know I will be driving or have stressful days at work. But it means- everyday! Now, my A1c is 8-9 but I can't live like that either. I don't want to lose my sight, have toe amputations, a heart attack, or lose my kidneys because of high blood sugar. I am trapped, depressed, Prozac does not help anymore. ... I live in constant fear and am miserable. Please help!
....and below, you will find the rest of each patient personal story .... after the islet transplants!
Tony and Mark
Both celebrating their
8th off insulin anniversary
after only one islet transplant!
Both had brittle T1DM with severe hypoglycemic episodes
Both had hypoglycemia unawareness,
Both had very poor quality of life
Both had high BMI=29
Both have had stable islet graft function
Both physically active (play tennis, run)
Both have now A1c 5.5
Both came to celebrate their anniversary with us
Nov 12, 2018
Tony: "I was rejected by two other islet transplant programs due to my high BMI, which was almost 30. I was so happy to be accepted into a study at University of Chicago. I am even happier today celebrating 5 years completely off insulin after only one transplant and testing today confirmed my stable islet graft function!"
Mark: "Dr. Witkowski, do you remember that you wanted to reject me too due to my high BMI, slightly over 30?"
Dr .W: "Yes, I believed I could not help you, even with multiple islet transplant."
Mark: "But I did loose weight and you had no choice to accept me :)"
Dr. W: "Yes, and I still can't believe you not only were able to stop insulin completely after only one transplant but also remained off insulin for over 5 years. It is extraordinary outcome and we all need to learn from that!"