Kirstie Danielson, assistant professor of medicine and public health.

Minimally invasive islet transplantation for patients with type 1 diabetes achieves insulin independence and reverses the progression of atherosclerosis in the first few years after transplant, according to a University of Illinois at Chicago study.

The research is published in the February issue of the journal Diabetes Care and is available online.

Patients with diabetes, particularly women, have a substantial increased risk of dying from ischemic heart disease, according to previous research. However, future cardiac events may be prevented with intensive glycemic control.

In the current longitudinal study, UIC researchers looked at changes over time in carotid intima-media thickness, or CIMT — a marker for atherosclerosis — in a group of type 1 diabetes patients without kidney disease or previous cardiovascular events.

“This is the first study to look at what happens to diabetes-related cardiovascular complications after islet cell transplantation alone without kidney transplant,” said Kirstie Danielson, assistant professor in the UIC College of Medicine and School of Public Health, and lead author of the study, who noted that previous research has focused on metabolic changes and glycemic control after transplant.

The 15 adults (two men and 13 women) suffered from type 1 diabetes for more than five years and had hypoglycemic unawareness despite best efforts to manage insulin levels. The patients received a total of 27 islet transplants (one to three transplants each) and were followed from one to five years after their first transplant. CIMT was measured before and approximately every 12 months after the first islet transplant.

The researchers found a significant decrease in CIMT one year after islet transplant. The CIMT measures started to progress again — slightly more than they would in healthy individuals without diabetes — between 12 and 50 months. At 50 months, post-transplant the CIMT measures were still lower than pre-transplant levels, Danielson said.

“The decline of CIMT we saw at one year is not generally seen in patients with diabetes,” said Danielson, who attributes the improvements to better glycemic control achieved through islet transplantation and better management of cholesterol, or lipid levels, post-transplant.

All 15 patients achieved insulin independence after receiving one to three islet transplants at the University of Illinois Hospital & Health Sciences System. At the end of the current study, 11 patients were insulin free, three remained on insulin but at greatly reduced doses, and one patient withdrew from the trial because of islet graft loss.

The next step would be to replicate these results in a larger trial, Danielson said.

Co-authors include Dr. Jose Oberholzer, Dr. Enrico Benedetti, Dr. Alessandra Mele, Dr. Meirigeng Qi, Joan Martellotto and Katie Kinzer from the UIC College of Medicine, Dr. Betul Hatipoglu from the Clevelend Clinic, and Dr. Bruce Kaplan from the University of Arizona.

The University of Illinois Hospital & Health Sciences System provides comprehensive care, education and research to the people of Illinois and beyond. The UI Health System includes a 495-bed tertiary hospital; the University of Illinois at Chicago Colleges of Medicine, Dentistry, Pharmacy, Nursing, Applied Health Sciences, School of Public Health and the Jane Addams College of Social Work; 22 outpatient clinics located in Chicago; 12 federally qualified health centers throughout the city; and Colleges of Medicine and affiliated health care facilities in Urbana, Peoria and Rockford.

For more information: The University of Illinois Hospital & Health Sciences System.

Participating in a marathon is a pretty amazing feat for anyone, but five people taking part in the 26.2-mile Bank of America Chicago Marathon on Oct. 7 share something that makes this amazing feat extra special: all of them were formerly dependent on insulin, but have had an islet cell transplant and are now living their lives diabetes-free!

Islet cell transplantation is what connects the five together as members of the athletic team Cellmates On The Run (!), going after the opportunity to compete in marathons, triathlons and other endurance fitness events together. In addition to the Chicago Marathon, Cellmates will also participate in the Chicago Half Marathon in September and the NYC Marathon in November!

Aside from the fact that it’s so cleverly named, the team serves as a research funding mechanism for the Chicago Diabetes Project (CDP) headquartered at the University of Illinois Hospital and Health Services. A global collaboration of scientists working on islet cell transplants, encapsulation, and new cell creation, the CDP is modeled after the Human Genome Project and has conducted 10 islet cell transplants in Phase I clinical trials since the program began in 2004.

So far, all of the transplant patients successfully came off insulin.

As the only program of its kind, the CDP helps raise money for its research by recruiting transplant recipients to be a part of the Cellmates team. Founded in 2009, the team has a total of 180 runners, ranging in age from 17 to 70 and including beginner athletes and experienced marathoners. Team organizers estimate about half of the team has a specific D-connection, with about 10% being type 1 PWDs — including the five islet transplant recipients who are technically not type 1s anymore! — and about 40% being people who have family or friends with diabetes.

While only 10 have gone through this Chicago-based research trial, hundreds of patients across the U.S. and globally have had these Islet cell transplants done in the past few years. This procedure, which is still in the clinical trial phase, is currently the only way to “cure” a PWD. But it’s not a complete cure because there are a lot of imperfections to the process. Most importantly, anyone undergoing this procedure must be on lifelong immuno-suppressant drugs to keep the autoimmune system from destroying the foreign islet cells.

Also, there’s the sourcing issue. For the average PWD, it takes 2-3 pancreases obtained from cadavers (organ donors) to do an islet cell transplantation. Several pancreases are needed per procedure because islet cells are incredibly fragile and many of them are destroyed in the transplant process. Keep in mind that there are only approximately 15,000 cadaveric pancreases available in the country each year — definitely not enough to cure everyone with diabetes! This is one of the reasons behind the push for using embryonic stem cells to create islet cells.

The procedure itself takes just about an hour, and is basically a “big injection” into the portal vein of the liver, done while the patient is awake but drowsy. You can read the details of how it’s done here.

The Chicago Diabetes Project, along with other research centers, is working on ways to transplant the islets into patients without the need for immuno-suppressant drugs. Because of the low number of available islet cells and the dangers of the drugs, not just any PWD can get a transplant. PWDs who wish to be part of the studies must demonstrate that their quality of life with the disease is currently very poor, and that living with diabetes (because of hypoglycemia unawareness or other complications) is worse than the dangers that come from a transplantation procedure.

Suzi Johnson, transplant patient

Such is the case for Suzi Johnson, a 55-year-old transplant recipient and runner for Cellmates, who says that the Chicago Diabetes Project changed her life after she developed hypoglycemia unawareness.

“The severe blood sugar swings left me both physically and emotionally drained and occurred without any warning that a life-threatening condition existed,” explained Suzi, who was diagnosed 18 years ago at age 37. “When friends and family became apprehensive about leaving me alone, I feared that I was soon going to lose my independence or, the worst-case scenario, my life.”

Suzi researched her options and discovered the CDP, a four-hour drive from her home in Decatur, IL. After applying and being accepted into the trial, she received her islet transplantation in 2007 and has been completely off insulin ever since.

“I have energy and zest for life now that enables me to get up early four times per week to walk or jog 15 to 20 miles per week, and I intend to increase that a little each week in preparation for the marathon,” Suzi says. “Being free from insulin has given me such confidence that I quit my 20-year paralegal career to follow my passion and open my own dog boutique. I help people train dogs and I show dogs in both obedience and the sport of agility. Life is good!”

If you happen to be interested in joining the Cellmates team, you don’t need to be a hardcore marathon runner, either. One of the transplant recipients, 67-year-old Judith-Rae Ross, who was diagnosed with type 1 in 1979, is walking the Chicago Marathon to support the research that changed her life.

“Walking the marathon proved to me that I’m not a diabetes hostage anymore,” explains Judith, who received her transplant in 2009. “I’m living an exciting, insulin-free life. I’m walking the marathon again because I want to be a foot soldier for the cure. If my walking helps raise money, then I’ll tromp the 26.2 whenever Dr. Oberholzer asks me to do so.

Support the Cellmates?

There’s still time to be a part of Cellmates on the Run and take part in the Chicago Marathon!

The team is accepting new participants until Sept. 1, and all new runners (or marathon walkers) will need to raise a minimum of $1,000. But if you’re not up for a marathon, you can still support the research by donating to the team. All of the donated money goes directly to the research. Last year, the Cellmates team raised a total of $300,000 and they’re shooting for $500,000 this year!

That seems to us like money well spent to support a cause they call a “functional cure” for diabetes. Right now, islet cell transplantation is the only thing that has taken a PWD off insulin for an extended period of time. Sure, there’s no guarantee that the islets will last forever. We know that the immune response doesn’t just stop once it’s attacked the islet cells at diagnosis, so it’s still there running the background (marathon pun intended).

But this is promising research that has so much potential! We hope researchers at institutions like CDP are able to find better ways to source islet cells, transplant the cells more efficiently, and safer ways to protect the islets from our immune systems.

A Brooklyn Heights marathoner is heading to the Windy City to try to run Type 1 diabetes out of town.

Dylan Kwait, 33, is the only New Yorker to run in the Chicago Marathon as part of a 13-person relay team led by members of the U.S. Women’s Soccer Team on Sunday.

Kwait, who has Type 1 diabetes, was picked out of hundreds to join the soccer stars and earn a $5,000 donation for the Chicago Diabetes Project.

“The goal for a Type 1 diabetic is to live your life without limits, as though you don’t have the illness,” he said.

Kwait was diagnosed with the disease five years ago - only a few months after his father began his own battle with prostate cancer. The avid runner and sports enthusiast said he wears a pump that circulates insulin through his body and allows him to stay active.

Now, the radiology resident from Maimonides Hospital is balancing a heavy work schedule and a daunting training regimen - all while managing his condition.

“It’s a huge part of who I am in that I have to think about it all the time but it doesn’t impact my life. I’m not limited by it,” said Kwait, who added that he’s run more than 60 miles a week for the past eight months to train for the marathon.

Abby Wambach, a forward on the U.S. Women’s soccer team, said her brother Andrew also was diagnosed with the disease as an adult and said she knows how devastating the struggle can be.

“What he’s doing is triumphant and courageous,” Wambach said of Kwait. “To put marathoning into his daily life is one of the most inspiring things.”

By Mark Morales / DAILY NEWS WRITER

Officials for marathon sponsors Bank of America said they sifted through hundreds of applications from runners who wanted to be part of the relay team.

“We were looking for what really drives them in wanting to run this relay,” said company spokeswoman Diane Wagner. “As they’re running, they’ll be able to raise money for the charity of their choice, and the emotional connection they have with their charity is very meaningful.”

Participating in a marathon is a pretty amazing feat for anyone, but five people taking part in the 26.2-mile Bank of America Chicago Marathon on Oct. 7 share something that makes this amazing feat extra special: all of them were formerly dependent on insulin, but have had an islet cell transplant and are now living their lives diabetes-free!

Islet cell transplantation is what connects the five together as members of the athletic team Cellmates On The Run (!), going after the opportunity to compete in marathons, triathlons and other endurance fitness events together. In addition to the Chicago Marathon, Cellmates will also participate in the Chicago Half Marathon in September and the NYC Marathon in November!

Aside from the fact that it’s so cleverly named, the team serves as a research funding mechanism for the Chicago Diabetes Project  (CDP) headquartered at the University of Illinois Hospital and Health Sciences System. A global collaboration of scientists working on islet cell transplants, encapsulation, and new cell creation, the CDP is modeled after the Human Genome Project and has conducted 10 islet cell transplants in Phase I clinical trials since the program began in 2004.

So far, all of the transplant patients successfully came off insulin.

As the only program of its kind, the CDP helps raise money for its research by recruiting transplant recipients to be a part of the Cellmates team. Founded in 2009, the team has a total of 180 runners, ranging in age from 17 to 70 and including beginner athletes and experienced marathoners. Team organizers estimate about half of the team has a specific D-connection, with about 10% being type 1 PWDs — including the five islet transplant recipients who are technically not type 1s anymore! — and about 40% being people who have family or friends with diabetes.

While only 10 have gone through this Chicago-based research trial, hundreds of patients across the U.S. and globally have had these Islet cell transplants done in the past few years. This procedure, which is still in the clinical trial phase, is currently the only way to “cure” a PWD. But it’s not a complete cure because there are a lot of imperfections to the process. Most importantly, anyone undergoing this procedure must be on lifelong immuno-suppressant drugs to keep the autoimmune system from destroying the foreign islet cells.
Also, there’s the sourcing issue. For the average PWD, it takes 2-3 pancreases obtained from cadavers (organ donors) to do an islet cell transplantation. Several pancreases are needed per procedure because islet cells are incredibly fragile and many of them are destroyed in the transplant process. Keep in mind that there are only approximately 15,000 cadaveric pancreases available in the country each year — definitely not enough to cure everyone with diabetes! This is one of the reasons behind the push for using embryonic stem cells to create islet cells.

The procedure itself takes just about an hour, and is basically a “big injection” into the portal vein of the liver, done while the patient is awake but drowsy. You can read the details of how it’s done here.

The Chicago Diabetes Project, along with other research centers, is working on ways to transplant the islets into patients without the need for immuno-suppressant drugs. Because of the low number of available islet cells and the dangers of the drugs, not just any PWD can get a transplant. PWDs who wish to be part of the studies must demonstrate that their quality of life with the disease is currently very poor, and that living with diabetes (because of hypoglycemia unawareness or other complications) is worse than the dangers that come from a transplantation procedure.

Such is the case for Suzi Johnson, a 55-year-old transplant recipient and runner for Cellmates, who says that the Chicago Diabetes Project changed her life after she developed hypoglycemia unawareness.

“The severe blood sugar swings left me both physically and emotionally drained and occurred without any warning that a life-threatening condition existed,” explained Suzi, who was diagnosed 18 years ago at age 37. “When friends and family became apprehensive about leaving me alone, I feared that I was soon going to lose my independence or, the worst-case scenario, my life.”

Suzi researched her options and discovered the CDP, a four-hour drive from her home in Decatur, IL. After applying and being accepted into the trial, she received her islet transplantation in 2007 and has been completely off insulin ever since.

“I have energy and zest for life now that enables me to get up early four times per week to walk or jog 15 to 20 miles per week, and I intend to increase that a little each week in preparation for the marathon,” Suzi says. “Being free from insulin has given me such confidence that I quit my 20-year paralegal career to follow my passion and open my own dog boutique. I help people train dogs and I show dogs in both obedience and the sport of agility. Life is good!”

If you happen to be interested in joining the Cellmates team, you don’t need to be a hardcore marathon runner, either. One of the transplant recipients, 67-year-old Judith-Rae Ross, who was diagnosed with type 1 in 1979, is walking the Chicago Marathon to support the research that changed her life.

“Walking the marathon proved to me that I’m not a diabetes hostage anymore,” explains Judith, who received her transplant in 2009. “I’m living an exciting, insulin-free life. I’m walking the marathon again because I want to be a foot soldier for the cure. If my walking helps raise money, then I’ll tromp the 26.2 whenever Dr. Oberholzer asks me to do so.

Support the Cellmates?
There’s still time to be a part of Cellmates on the Run and take part in the Chicago Marathon!
The team is accepting new participants until Sept. 1, and all new runners (or marathon walkers) will need to raise a minimum of $1,000. But if you’re not up for a marathon, you can still support the research by donating to the team. All of the donated money goes directly to the research. Last year, the Cellmates team raised a total of $300,000 and they’re shooting for $500,000 this year!

That seems to us like money well spent to support a cause they call a “functional cure” for diabetes. Right now, islet cell transplantation is the only thing that has taken a PWD off insulin for an extended period of time. Sure, there’s no guarantee that the islets will last forever. We know that the immune response doesn’t just stop once it’s attacked the islet cells at diagnosis, so it’s still there running the background (marathon pun intended).

But this is promising research that has so much potential! We hope researchers at institutions like CDP are able to find better ways to source islet cells, transplant the cells more efficiently, and safer ways to protect the islets from our immune systems.

When Marian Cardwell dives into the English Channel in July, she will be attempting a feat that has been completed by less people than those who have successfully climbed Mount Everest.

The swim is 21 miles from Dover, England to Cap Gris Nez, France, but it has been said people often swim up to 30 miles across the channel because the ocean currents and weather are unpredictable and can easily take people off course. As the tides change every six hours, swimmers often cross over the Channel in an “S” shaped pattern.

The Channel is part of the Atlantic Ocean that separates the south of England and the north of France. The Channel has been characterized as having some of the busiest shipping lanes in the world, so Cardwell will not only have to contend with large boats and their wake of wave patterns they create, but she will have to deal with cold water temperatures—which vary from between 57 and 62 degrees in the summer months—and could suffer potential jellyfish stings during her swimming trek.

In terms of her swimming experience, Cardwell swam in both high school and college having competed in the 400 yard individual medley, and 500 and 1650 yard freestyle. As many athletes do, she has suffered injuries along the way. She tore her labrum and rotator cuff in her left shoulder, with both injuries requiring surgeries. Later she was hit by a car while biking and separated the same shoulder. While the car accident did not require surgery or any extended physical therapy, it reaggravated an already vulnerable body part and added to chronic shoulder pain, which mostly flairs up when she swims.
Despite her nagging left shoulder pain and the potential obstacles of the Channel, Cardwell is the type of person who believes in taking challenges head on. For example, Cardwell is planning to go to medical school in the next few years and aspires to work as a physician in French-speaking west Africa. Therefore, to bolster her French speaking skills, she decided to move from her home in Wheaton, Illinois to France. Cardwell is living in the town of Lille working as an English teaching assistant for the year.

Along with her straightaway determination in tackling this incredibly rare athletic endeavor, Cardwell always has her beloved Uncle Wally in her mind while she trains. Wally Filkin has successfully navigated type 1 diabetes for nearly 57 years, and has served as an inspiration to his family.
While he has excelled with his disease management for decades, in the last couple of years, he has suffered a series of health problems starting with a stroke in 2010 and most recently being diagnosed with congestive heart failure last year.    

Knowing she was going to be thousands of miles away from her uncle during a time when his health was very fragile, she decided to bridge the miles physically by dedicating the Channel swim to him and raising money for the Chicago Diabetes Project, whose work her uncle admires.
 
She is currently training in a pool, but she lives close enough to the Channel to drive over and train there, which she expects to do in the next couple of months to acclimate herself to the frigid water temperatures. As part of the tradition but also to legitimize an official channel crossing, there are specific rules. Swimmers are only allowed to wear a regular swim suit—no full body suits allowed—head cap, goggles, ear plugs, and a special concoction of petroleum jelly and lanoline, which can be slathered on to help keep the body insulated.

DiabetesCare.net spoke with Cardwell to find out more about her Uncle Wally, the work of the Chicago Diabetes Project, and her quest to conquer the Channel.

DiabetesCare.net: What made you decide to say, ‘I’m going to swim the English Channel as a way of raising money for the Chicago Diabetes Project?’

Cardwell: Someone once suggested that I could swim the Channel. With my uncle’s condition and my placement in Lille, I started seriously thinking about it, and it became clear to me that I wanted to swim for him and for the Chicago Diabetes Project. It was hard for me to be away while he was getting sicker and swimming the Channel felt like a way I could continue to show my love and support from a distance.

DiabetesCare.net: Please tell us about your Uncle Wally (pictured here on the left, and her father, and Marian).

Cardwell: He is married, and has two married sons and eight grandchildren. He is a loving man, and everyone in our family has a great respect for him. He is clever, witty, and always has us laughing. At the same time, he is articulate. I would never want to get into a debate with him because I would definitely lose. 

He is also disciplined and athletic. He was diagnosed with type 1 diabetes when he was 15 and is almost 72 now. When he was diagnosed there were not a lot of treatment options and trying to figure out glucose control was more of a guessing game. When he was diagnosed, he was worried he wouldn’t be able to play basketball anymore but the doctor told him if he took care of himself he could play.   

My uncle once spent an afternoon with Ron Santo (former Chicago Cubs third-baseman who also had type 1 diabetes), and found Ron had a similar experience. They were diagnosed at about the same point in their lives, and they both believed that a love of a sport helped them with their own disease management. What baseball was for Ron, basketball was for my uncle. It was a great motivator and taught him how to take care of himself. He ended up playing basketball in high school, college, and for various church leagues after college.

DiabetesCare.net: Why are you donating to the Chicago Diabetes Project?

Cardwell: I decided to choose this organization because of my uncle. He is well read on diabetes research and he likes to stay informed, as he has lived with the disease for most of his life. He is enthusiastic about the Chicago Diabetes Project and believes they will provide a cure for type 1 diabetes.
Because of his enthusiasm, I looked into the CDP’s research and quickly understood why it was exciting. They are performing islet cell transplants and have had a very good success rate. The patients who have successful transplants are no longer insulin-dependent. 

DiabetesCare.net: Your uncle has certainly been a survivor. Why the decision now? Was there a point at which you said, ‘I want to do this for this particular reason?’

Cardwell: In 2010 he had a stroke, and it radically changed everything for him and his immediate family. He had to relearn how to do everything. Slowly things improved, and we celebrated milestones like swallowing and walking. After a tough three months, he was released from the hospital, and six months after the stroke he was able to maintain a regular routine in his life. He was even able to celebrate my sister’s wedding.

Almost seven months after the stroke, he slipped and cracked his pelvis. Despite the setback, he kept his determined spirit to heal, and he recovered. He and my aunt were even able to return to Florida where they spend about half the year. But almost a year after he broke his pelvis, he fell again—this time breaking his hip. As before, he kept the same mindset of, “I will get through this,” and he did. After he recovered from his broken hip, he was doing quite well, and he and my aunt returned to Florida. But this turned out to be an unexpectedly quick trip—soon after they arrived, my uncle started to get sick. He was diagnosed with congestive heart failure.  

My uncle and aunt returned home this past Thanksgiving, and it was hard for me because I was here in France, unsure of what was going to happen. Surgery was an option for him, but the doctor told him the recovery would be too hard on his body. Fortunately, even without surgery, his condition has been stable over the last few months.

Battling injuries and health issues are difficult enough, but when they keep coming, you just want to say, ‘come on I want a break,’ yet he is always determined to recover and he always does. While he is not likely to return to the same level of health and activity that he enjoyed before the stroke, that doesn’t stop him from doing as much as he can.

Stroke and congestive heart failure are both side effects of lifelong diabetes. There have been quite a few times where I have thought about and appreciated the shortness of life and I would like to do this to honor him rather than in memory of him. He is alive and my shoulder is strong, so in a way it is like we are both able to do this now.

DiabetesCare.net: Can you talk about your training routine?

Cardwell: Right now, I lift weights twice a week. I also swim twice a day, three or four days a week and once a day two or three days a week for a total of six days every week.  Normally, I swim about 30-35 kilometers a week (about 18 to 21.8 miles), but this week I hit over 40.
In May, I will go up to training 40-50 kilometers per week. Then in July, I will begin to taper my miles back right before the channel swim.

DiabetesCare.net: In training for endurance events like marathons or long swims, there is a long training run or swim a few weeks before the big event to ensure the person is ready. How long will your long swim be? 
 


Cardwell: I would like to do one 30K swim before the end of June in cold water. There are also a series of swims in the middle of June that I will be doing including a 5K, 10K, and a 25K. I will do these in a three-day period.

DiabetesCare.net: As it is March, it is a bit too cold to go into the ocean right now. At what point will you be looking to get into the Channel to acclimate your body to the frigid waters?

Cardwell: I will likely start swimming the ocean water in May. I’m lucky to be close enough to the Channel (pictured below) that I could go there on a Saturday. Since the water will be about 60 to 62 degrees when I swim, and because I’m not allowed to wear a wet suit, I’m eager to start acclimating myself to cold water.  Also, in order to qualify for the Channel, I must do a six-hour certified cold-water swim. Otherwise, the boat captain won’t take me out.

DiabetesCare.net: In terms of support, who is helping you during the training and during the actual swim?

Cardwell: The people here, in the north of France, have been unbelievably welcoming. I had initially been going to a public pool, but then I met a coach and he welcomed me onto his team. I train with them in the afternoons. This coach also introduced to me to the coach of their ‘sister team’ who I train with in the mornings. If it weren’t for these two incredible people, this swim would not be possible.

During the actual swim, my mom and two dear friends will accompany me on the boat. Their job will be feeding me, keeping me hydrated, encouraging me, and hopefully not getting too seasick.
 


DiabetesCare.net: Aside from the actual distance what are the biggest physical challenges you believe you will face?

Cardwell: The cold temperature will be one. There is also a good possibility that I will be stung more than once by a jellyfish. As I have never had to swim that long, I am also concerned about my shoulder. But at the same time, the cold water or a jellyfish sting could distract me from my shoulder—that’s positive (she laughs). 

DiabetesCare.net: When are you planning to swim the Channel?

Cardwell: I have a time slot between July 10 and July 18.  My boat captain has three other people trying to cross that week, and I am in the fourth position. The swimmer in the first position will be offered a chance to swim first, but if he turns it down, it will go to the second person, etc, and finally to me. I will call my captain every day and he will either say, yes or no depending on the weather and the other swimmers’ responses. So it’s a waiting game. I won’t ever know the day until about 12 hours before. 

Like the day, the time also depends on the weather. Some people start at two or three in the morning and others start around seven or eight. If I do head out before the sun, I will have a little flashlight attached to my cap, so the boat crew can see me.

Though the weather directs when I will be able to swim, my captain directs me. He has a good record for successful crossings, and I feel very lucky to have him. According to other Channel swimmers, he is the best there is.

DiabetesCare.net: How long do you expect to be in the water, and do you have any specific goals for your swim?

Cardwell: I hope I will be in the water for about 12 to 14 hours. My biggest goals are to finish and to enjoy it. By the time July comes around, I’ll have done all the hard preparation work. The only thing left will be a chilly, and perhaps stinging swim. So when it finally comes to the swim, my goal is to do it with a smile on my face and to enjoy the ride. I’m thrilled to have this opportunity to honor my uncle.
  
Contributions for Cardwell’s fund to support the Chicago Diabetes Project can be made directly here, and to read her blog go to her website here. 

By: John Parkinson, Clinical Content Coordinator, DiabetesCare.net

Waiting for the phone call. Islet cell transplant recipients often speaking of waiting for the go-ahead to prepare themselves for going to the medical center to have their transplant performed as one of the most difficult and exciting times during the transplant process. There are moments of trepidation and others filled with the hopeful joy of thinking about what may lie ahead after a transplant.

The surgeons are also waiting, because there is limited availability of islets as their only source is pancreases from cadavers.
Waiting for a suitable donor can mean there is a lull between procedures that limits their ability to help more type 1 patients. This is one of the biggest frustrations for Dr. Oberholzer who performs these procedures. 

As director of the Chicago Diabetes Project, Dr. Oberholzer and his team are investigating ways to grow islet cells.

In addition to his work on the Chicago Diabetes Project, Dr. Oberholzer (pictured, lower left) is a Professor of Surgery, Endocrinology and Diabetes, and Bioengineering at the University of Illinois at Chicago (UIC), the Director of the Islet and Pancreas Transplant Program, and the Chief of the Division of Transplantation at the University of Illinois Hospital.


Still many of the patients who have gone through the entire islet cell transplant process are excelling and remain insulin-independent for years. It is important to provide an understanding of what the process entails; therefore, DiabetesCare.net spoke to Dr. Oberholzer about what it is like to walk a person through the transplant process from the clinical criteria for prospective patients, to the challenges associated with the transplants, and the expectations for potential outcomes post operatively.

DiabetesCare.net: When talking with prospective patients, what is the criteria you are looking for in determining if they would be a good candidate for islet cell transplantation?



Oberholzer: When seeing if someone is suitable, the first question I have to ask is does the patient have a problem that would justify some risks? With someone with perfectly controlled diabetes, I would not consider the person for treatment.
 
The most common problem where we can justify the risks for the transplant and the immunosuppressant drugs is hypoglycemic unawareness. Luckily, it is not a very common condition. 
 
We will try to treat the patient conservatively first. We will put him or her on a pump, and glucose sensor, but in most cases when they have hypoglycemic unawareness, the only way to treat them is to do a pancreas transplant or an islet transplant.
 
We are not seeing this as frequently but occasionally we will get a call from a patient’s ophthalmologist, who is seeing someone who has rapidly progressing diabetic retinopathy. In these cases we will do a pancreas or islet transplant. For those who are suitable, I would rather go for an islet as opposed to a pancreas procedure.



DiabetesCare.net: How do you decide when a person is a better candidate for a pancreas or islet cell transplant?



Oberholzer: An islet cell transplant cannot offer as many islets as a pancreas, because in the process of isolating the islets you lose a percentage of them. 
 
If someone is obese or has high insulin requirements, then an islet cell transplant is going to be difficult. In those cases, I would opt for a pancreas transplant. And the opposite applies for whom I would consider a candidate for an islet transplant.
 
Generally, we calculate how many units of insulin a patient needs per day and then we divide it by the body weight. 
 
Islet cell transplantation is an experimental procedure and can only be offered with the framework of a clinical trial, and in these, there are inclusion and exclusion criteria. Even if someone presents with the aforementioned criteria, there may be reasons within the trial parameters that they cannot fit the protocol.
 
Reasons for exclusion might be reduced kidney function or tissue sensitivity or maybe there are other reasons outlined in our FDA-approved protocol.
 


DiabetesCare.net: How do you characterize islet cell transplantation when you speak to a patient about the surgery? Is it a cure? A remission of symptoms? Both?
 


Oberholzer: When I talked to patients about the procedure, I talk about it being a “functional cure.” This means from patients’ perspectives, they will feel like they no longer have diabetes. Their blood sugars will be normal; they won’t have to inject insulin; and so in that way, they are cured. 
 
The reason I tell them they are not cured from a traditional standpoint, is if they reject the transplant, they will be back to being diabetic. We can reproduce the function of the insulin producing cells, but the transplant cannot eliminate the underlying disease. 
 
As long as they take their immunosuppression medicines, most patients will be safe from their diabetes. However, if for some reason they don’t remain on their medication regimen, or their immune system gets activated, they may lose the transplant. 
 


DiabetesCare.net: Speaking of immunosuppressants, it was recently reported that Rapamycin, a drug used for transplant and cancer patients, has been blamed for causing diabetes-like symptoms. Have you used it for transplant patients? What is the post-op regimen prescribed for islet cell transplant recipients? 



Oberholzer: You start off with a higher level of immunosuppression and then you taper the amount of the regimen later through the process. In the beginning we perform induction therapy and we use an antibody medicine. There are various drugs you can use. Our post-transplant regimen includes Prograf (tacrolimus) and Rapamycin (sirolimus).
Rapamycin is a complicated drug, but it has been a major contribution to the success of islet cell transplantation. Not all patients will tolerate it, and in those patients, we go to an alternative drug that we use called MMF.
The side effects of these medications can go from almost nothing to the point where a patient has to be taken off of them. The vast majority of patients tolerate them very well. I think it is a bit of a misconception that is out there about Rapamycin. Some people may think it is terrible, but if you talk to our patients, most of them have been taking it for years and don’t feel any effects.

DiabetesCare.net: Is there a medical metric or criteria to measure people on these immunosuppresants?



Oberholzer: We monitor the graft function and the blood sugar levels in the body. On a regular basis, we do metabolic tests, like an oral glucose tolerance test, just to make sure their glucose function is still normal.
In addition to those tests, we do monitor the immunosuppresion drug levels. Those medicines have to be titrated to reach a certain level because we don’t want to give too much and reach toxicity or give too little and the patients reject the transplant. We have to find the right balance.
In the blood work, we monitor for potential side effects, and we look for things like a low white blood cell count or kidney dysfunction.

DiabetesCare.net: Can you take me through what islet cell transplant recipients do post-op in terms of their care including which medical providers they see and how often?

Oberholzer: At the CDP, we do all the post-op care and collaborate with their primary care physicians. In general, we see more of the patients in the beginning, and then gradually less and less, once the risk of losing the transplant lessens.
In the first two weeks post-op, we will see them three times a week. Then we will see them twice a week for two weeks. Then we will see them weekly up until three months post-transplantation.
After three months, we will see them on a monthly basis. Once they go beyond the first year, we will see them every three months.  We will continue to do that for as long as the islet cell transplant works and they are on immunosuppression medications.
We will go through their glucose readings and there are educational aspects including how to take the medications and lifestyle issues, like dietary recommendations.
We answer any questions the patients have and go through general post-op recommendations on how to handle lifestyle situations.

DiabetesCare.net: Do you have a diabetes educator on staff who sees the patients post-op?

Oberholzer: Post-op, the patients generally don’t have diabetes, but patients may have questions about their diets. We offer any medical support a patient may need. We want them to remain as close to a diabetic diet as possible. Sometimes there are questions that a dietitian can answer.
We also have other support such as social workers or psychologists available to address mood change issues or related problems.

DiabetesCare.net: Can you provide some data on the surgical outcomes in terms of long-term transplant patients?
Success rates? Anything to provide a sense of the efficacy of the procedure?

Oberholzer: At present, we can get almost everyone off insulin. In our present trial, we are approaching 30 patients. We have had only one patient who lost their islet transplant within two weeks of the operation. At one year after transplantation, 8 out of ten patients are off insulin. Therefore, we have an 80 percent success rate after one year. And at five years, 60 percent of our patients remain insulin-independent.

DiabetesCare.net: How many transplants have you performed?

Oberholzer: Here in Chicago, we are approaching 30 patients. I believe we are at 28 total. In my previous experience in Geneva, I believe we were close to 50 transplants. Additionally, I was in Edmonton for a brief period, where numerous patients were transplanted.
While these are not huge numbers, I’m likely to be considered as someone who has performed more transplants than most surgeons who are doing the transplant world-wide.

DiabetesCare.net: What are the biggest learning curve elements for patients post-transplant?

Oberholzer: One of our researchers explained it very well when she said, ‘we are helping them to perform a transformation of their bodies.’ They go through a dramatic change where most of it is good, but some of it can feel unsettling at first. For example, for many of the patients who have diabetes, their nerves don’t operate or feel normal. Some patients post-op regain feeling in their feet and their nerves begin tingling when they start to regain the feeling. Other patients say their taste buds change. They didn’t realize their sense of taste was reduced, but then they start tasting things they didn’t before.

The biggest aspect that is most impressive to see is that these patients learn to regain confidence. Most of these patients had lost their confidence because they were scared they would have a severe low. These patients would always have someone with them to avoid this. And now post-op, they realize they can exercise and do things without having to worry about going low.

It takes some time to adjust to this; it is like a regained liberty. One of our patients wrote that she felt like she was in prison when she was diabetic, and now we let her out, and she had to relearn what it was like to be free.

This is the second installment in a two-part interview. In the first installment, DiabetesCare.net spoke with Dr. Oberholzer about the Chicago Diabetes Project’s islet cell research and its transplantation ambitions for the future. That story can be viewed here.

Published: May 21, 2012

The University of Illinois Hospital & Health Sciences System led by Dr. Jose Oberholzer, joined a coalition of healthcare organizations lead by MinuteClinic to help raise awareness about diabetes at a school on Chicago’s South Side. Students at Perspectives Charter School Calumet Campus participated in the screening throughout the week of May 14th and will be offered follow up care if they are diagnosed with pre diabetes or diabetes. Volunteers from UI Health provided the BMI screenings, and if a child had a high BMI then nurses from MinuteClinic did a finger stick test to measure blood glucose.

A highlight for many of the students was an appearance by Chicago Bears quarterback Jay Cutler. Cutler has type 1 diabetes, and runs his own organization which benefits children with the disease. His appearance brought nearly 10 media outlets to the event - raising even more awareness about the importance of living a healthy lifestyle and getting screened for diabetes.

As of Thursday morning over 160 kids ranging from 6th grade to high school seniors were tested.  The results show a significant need for continued education and screening.

  6th grade 13 of 21 were higher than 85th percentile = 62% with high BMI.
  7th grade 17 0f 40 were higher than 85th percentile = 43% with high BMI.
  8th grade 10 of 21 were higher than 85th percentile = 48% with high BMI.
  High School 31 of 78 higher than 85th percentile = 40% with high BMI.

Dr. Oberholzer and his team will be going through each screening result and providing the ACCESS clinic with the names of students who need to set up follow up appointments.

The representatives from the Greater Auburn Gresham Community Center and ACCESS Health Clinic located within the school see a great need for continued education and after school programs to help these children become more active and make healthier life style choices.  Educators thought the event was exceptionally successful at improving access to healthcare for the kids and their families, and they were exited to be partnering with the University of Illinois Health System.

The University of Illinois Hospital & Health Sciences System provides high quality care to those who need it most. As part of the UI Health System’s community outreach initiatives, physicians and nurses will continue to focus on educating and providing care for those with health disparities like diabetes.

Bank of America today recognized Dr. José Oberholzer, director of the Chicago Diabetes Project, as the second annual recipient of the Mayor Richard M. Daley and Maggie Daley Award. The award was established in 2010 to honor the Bank of America Chicago Marathon participant who raised the most funds for charity through the annual world-class endurance event. Dr. Oberholzer and his team, Cellmates on the Run, raised more than $125,000 for the Chicago Diabetes Project, which is a collaboration of scientists, researchers, physicians and surgeons dedicated to curing diabetes. Former Chicago Mayor Richard M. Daley joined race director Carey Pinkowski and Bank of America Illinois President Tim Maloney in presenting the award to Dr. Oberholzer at yesterday’s Bank of America Chicago Marathon Charity Reception.

“Dr. José Oberholzer and the Chicago Diabetes Project embody the charitable spirit and community focus of the Bank of America Shamrock Shuffle and Bank of America Chicago Marathon,” said Maloney. “It’s an honor to present this award to José, as he oversees a project in Chicago that is committed to advancing diabetes research, and to ultimately finding a cure for a disease that more than 1.3 million people in the United States are diagnosed with each year.”

The Chicago Diabetes Project’s charity team became an official charity with the Bank of America Chicago Marathon in 2009. In the last three years, the team has raised approximately $300,000 through Marathon fundraising efforts.

“The Cellmates on the Run team is grateful to participate in the Bank of America Chicago Marathon year-over-year as one of the official charities,” said Oberholzer. “The mission of the Chicago Diabetes Project is to make islet cell transplantation the most promising treatment for diabetes and a viable option for everyone who suffers from it. The Bank of America Chicago Marathon provides tremendous support for the Chicago Diabetes Project by helping our team to raise awareness in the fight against this aggressively growing epidemic.”

As director of the Islet and Pancreas Transplant Program at the University of Illinois at Chicago (UIC) and chief of its Division of Transplantation, Dr. Oberholzer has dedicated his career to finding a cure for diabetes. He is also an associate professor of surgery, endocrinology and diabetes, and bioengineering at UIC.

“Dr. Oberholzer and his team run with a simple, yet powerful, goal – to advance diabetes research,” said former Mayor Richard M. Daley. “The Chicago Diabetes Project and Cellmates on the Run demonstrate how the Marathon helps enable Chicago residents and organizations to expand on their charitable efforts – not just in Chicago, but throughout the world.”

At the 2011 Bank of America Chicago Marathon, the fundraising prowess of the Chicago Diabetes Project contributed to an event record $13.4 million for more than 160 nonprofit organizations to advance local, national and global causes.

Although the 2012 Bank of America Chicago Marathon is completely sold out, the only way to register with a charity team is by visiting www.chicagomarathon.com for program details. The deadline to register through a charity is June 29, 2012 or until an individual charity has filled its available registration slots. This year’s race is on Sunday, October 7, 2012.

The Bank of America Shamrock Shuffle 8K and Bank of America Chicago Marathon combined are two of the largest fundraising events in the state of Illinois and act as drivers for economic growth for the city of Chicago. In addition to being the opening of the spring running season and a perennial festive event that features 40,000 runners, the Shamrock Shuffle kicks off a long fundraising effort – culminating with the Marathon in October. The Bank of America Chicago Marathon’s charity program was formally established in 2002, followed by the Shamrock Shuffle’s program in 2009. Since 2002, the events have raised more than $80 million for charitable causes.

Bank of America Shamrock Shuffle 8K

Long recognized as an annual rite of spring and the kick-off to the outdoor running season in Chicago, the Bank of America Shamrock Shuffle 8K takes runners on a scenic tour of downtown Chicago, starting and finishing in Grant Park. For more information about the event, go to shamrockshuffle.com.

About the Bank of America Chicago Marathon

In its 35th year and a member of the World Marathon Majors, the Bank of America Chicago Marathon annually attracts 45,000 participants, including a world-class elite runner and wheelchair field, and an estimated 1.7 million spectators. As a result of its national and international draw, each year, the iconic race assists in raising millions of dollars for a variety of charitable causes while generating $170 million in economic impact to its host city according to a report by the University of Illinois at Urbana-Champaign’s Regional Economics Applications Laboratory (R.E.A.L.). The 2012 Bank of America Chicago Marathon will start and finish in Chicago’s Grant Park beginning at 7:30 a.m. on Sunday, October 7. In advance of the race, a two-day Health & Fitness Expo will be held at McCormick Place Convention Center on Friday, October 5, and Saturday, October 6.

Bank of America

Bank of America is one of the world’s largest financial institutions, serving individual consumers, small- and middle-market businesses and large corporations with a full range of banking, investing, asset management and other financial and risk management products and services. The company provides unmatched convenience in the United States, serving approximately 57 million consumer and small business relationships with approximately 5,700 retail banking offices and approximately 17,250 ATMs and award-winning online banking with 30 million active users. Bank of America is among the world’s leading wealth management companies and is a global leader in corporate and investment banking and trading across a broad range of asset classes, serving corporations, governments, institutions and individuals around the world. Bank of America offers industry-leading support to approximately 4 million small business owners through a suite of innovative, easy-to-use online products and services. The company serves clients through operations in more than 40 countries. Bank of America Corporation stock (NYSE: BAC) is a component of the Dow Jones Industrial Average and is listed on the New York Stock Exchange.

For more Bank of America news, visit the Bank of America newsroom.

Publication Date: 4/20/2012
While the Chicago Diabetes Project (CDP) has thus far only performed islet cell transplants on a smaller subset of type 1 patients in clinical trials, their ultimate goal is to one day offer the transplant for everyone with diabetes—including type 2s. José Oberholzer, MD, director of the CDP, explains why this goal is possible, and how he intends to get there.

By: John Parkinson, Clinical Content Coordinator, DiabetesCare.net
An older man is walking down the beach and comes upon a young man collecting starfishes that a storm has stranded on the beach. Seeing the ones that are still alive, the young man throws them back into the ocean. The older man asks the young man, “what are you doing? There are so few starfishes that you can save.”

The young man bends down and picks up a living starfish and throws it back into the ocean, and he says, “it made a difference to this one.” This story came attached to a piece of crystal that is in Dr. José Oberholzer’s office and was given to him by one of his islet cell transplant patients. The patient—a long-time type 1 who became insulin-independent shortly after receiving a transplant—inscribed on the crystal, “Thanks for everything, starfish number 62.”

This story serves as a medical parable encapsulating both the hope and negativity surrounding islet cell transplantation. For people who have had a transplant, it has been life-transforming for a majority of them. On the other hand, there has been negative criticism coming from within the medical community that these transplants have served very few people and come attached with challenges like having to take a regimen of immunosuppression drugs. The procedure also still needs to be FDA-approved—some have speculated that might be coming in the next year or so.

Still, Dr. Oberholzer hears these criticisms, and chooses not to stay within these limitations, but rather moves beyond them in trying to transform this novel procedure for greater patient utilization. In fact, contrary to the view this procedure is limited in who it can help, the CDP has ambitious plans to try and treat the vast majority of both type 1 and type 2 diabetes patients with the islet cell transplant.

In speaking with Dr. Oberholzer, hope and resolve resonate through his voice. The fact of the matter is, this surgery is the closest thing to a cure that is out there on the horizon. Some of the patients who have this surgery remain insulin-independent for years.

To tell someone that has taken insulin for years that they no longer have to do so is unparalleled to any treatment out there for people who have type 1 diabetes and gives these patients a much improved quality-of-life. This is especially true in the patients who are the main recipients of the novel procedure through its clinical trials: those with hypoglycemic unawareness.

In describing the procedure, Dr. Oberholzer (pictured, lower left) calls islet cell transplantation a “functional cure,” where people become insulin-independent. He also points out that the underlying disease state is not treated; therefore, it is not a traditional cure.

Dr. Oberholzer is an Associate Professor of Surgery, Endocrinology and Diabetes, and Bioengineering at the University of Illinois at Chicago (UIC), the Director of the Islet and
Pancreas Transplant Program and the Chief of the Division of Transplantation at the University of Illinois Hospital . He has trained at the University of Geneva Switzerland, as well as at the University of Alberta in Edmonton, Canada—which was at the cutting of edge in developing the islet cell transplantation.

As director of the Chicago Diabetes Project, Dr. Oberholzer oversees a group of hand-picked scientists who fit a specific criteria. In creating this mini-elite team, the Chicago Diabetes Project has been able to focus on the specifics of creating a treatment for all people with diabetes and trying to deliver it without the use of immunosuppression drugs.

DiabetesCare.net sat down with Dr. Oberholzer recently to discuss his work on the Chicago Diabetes Project including its unique lab protocols, the CDP’s research philosophy, and how they are trying to overcome the post-transplant protocol of immunosuppression drugs by working on cell encapsulation.

DiabetesCare.net: How did you get involved in the Chicago Diabetes Project? 


Oberholzer: About 10 years ago, I was involved in a project with several scientists and we were talking about the human genome project. A few people involved in that research were able to pull many people together to focus on coding the human genome.

We wrote a paper where we postulated that in order to find a cure for diabetes we would need a human genome project like-minded model where scientists would commit to work together and share openly the data before it is published.

This type of project would need a common funding source where scientists would not worry about grants and could just focus on their work.

When I came to Chicago to work at the University of Illinois at Chicago, I was approached by the Washington Square Health Foundation. They said they would like to fund my idea of having a small group of dedicated scientists working towards a diabetes cure. They would give me a grant, if I committed to this work.

I was intrigued by it, and the university agreed to help me in whichever way they could to make such a project possible. That was at the end of 2004.

The foundation asked me to bring in key players from the field. We were going to meet for one week and at the end of it, we would come up with a roadmap on how we would go about making islet cell transplantation available to everybody.

The two questions that came out of that week were: how do we get an unlimited amount of insulin producing cells and how can we implant those cells without immunosuppression drugs?

In trying to answer these questions, we had our roadmap.
DiabetesCare.net: What makes the Chicago Diabetes Project unique in its approach and philosophy?

Oberholzer: The uniqueness of the CDP is that everyone on the project has committed to each other, and we share everything including innovations and inventions. We have done this as a simple gentleman’s agreement.

Our philosophy is to make a functional cure available to everybody. The main challenge right now is that we can only do islet cell transplantation for a limited patient population.
 
The main reasons we cannot offer this transplant to more people is that as it is an experimental procedure, we have to pay for all the costs; there are a limited amount of organ donors; and we have to give our patients immunosuppression drugs. While the vast majority of patients tolerate these drugs very well, some do not. And we would be very hesitant to use them in children.
 
We have gotten criticized at CDP that what we are doing is not worth it, because it only helps a few people. I have been in this work for nearly two decades, and people say the stories are very touching but very few can have islet cell transplantation.
 
However, many in the medical community recognize that most type 2s would benefit from having an infusion of insulin-producing cells. We postulate that if we did a pancreas transplant in type 2 patients, it would cure a vast majority of these patients.

DiabetesCare.net: Are you talking about a functional cure or a traditional cure for people with type 2 diabetes?

Oberholzer: I would call it a functional cure because in type 2 diabetes, there is no autoimmune issue like in type 1 diabetes, but there is an inflammatory process. Therefore, there still would be the risk of reoccurrence of diabetes. A potential islet cell transplant cannot be an isolated event; it has to be accompanied by lifestyle changes such as weight reduction in those who are obese.

For someone who has type 2 diabetes and they are on insulin, it is very difficult for them to lose weight, and in fact they often gain weight when on it. For example, if they inject too much insulin, then they have to compensate by eating more, then insulin makes them hungry again. It can be a vicious cycle.

You can interrupt this cycle by giving these people just enough islet cells for their bodies to overcome the insulin resistance.

In the Chicago Diabetes Project, we are not only working on therapies for type 1s but we are looking to help all diabetic patients—understanding we won’t be able to treat everyone, but at least the vast majority of them.

Members of the CDP are successful, academic scientists and we have all climbed up the career ladders starting as assistants and associates and becoming full professors. We have all had NIH grants. We have gone through the academic and scientific world and we know what competition means.

We also realize we are never going to find a cure for diabetes, if we continue to work in the traditional grant-funded research model. It is good for having competitive professors, but it horrible for addressing a cure.

Whatever we do in the lab, we ask the question, ‘is it going to contribute to a direct path to a functional cure?’ We don’t want to ask questions, just for the sake of asking; it has to have a practical implication in either creating more insulin-producing cells or protecting them by other means other than medication.

To be a part of the CDP team, you have to have some specific qualifications. I only chose people that have had their own funding; have made significant findings; and they have to be open to share and continue to work on the project even if their own research did not work.

Initially, this concept was very challenging. We had difficulty keeping some people on the project when they realized their research didn’t work. Still the vast majority of the original scientists are still here. 

DiabetesCare.net: CDP has been a participant in the Phase 3 clinical trial being conducted by the NIH Clinical Islet Transplantation Consortium. Where is the CDP with that now, and is the CDP still actively doing islet cell transplants?

Oberholzer: We are approaching the end of the phase 3 trial. We are still performing transplants in the consortium. This is limited now to patients who have had a kidney transplant and are taking immunosuppression drugs already. This is going to be wrapping up in the summer.  

For patients who have normal kidney function, that part of the trial is finished. However, we have a University of Illinois trial that is still going on, and we are still accepting patients. We have been pretty active this year having performed 6 transplants since January.  We will continue until the end of the year and likely beyond that. 

DiabetesCare.net: One of the more challenging elements to islet cell transplantation is that for those who have successful transplants, and remain insulin-free, they have to take immunosuppressants. The CDP is researching cell encapsulation to overcome this challenge. Can you explain what this is, and how far along in the process the research is?

Oberholzer: With encapsulation, the principle is to place a shell around the cell, which would allow the cell to live, gain nutrients, secrete insulin, sense glucose, and protect the islet from the body’s immune system.

In some ways this would be a semi-permeable membrane that lets through small molecules and keeps out large ones that would go through the cell encapsulation to attack the islet cells.
We have had limited clinical trials of which we were a part of through the Chicago Diabetes Project. We worked with a university in Italy and one in Sydney, Australia. Unfortunately, both trials were not a success.

The trial in Italy showed that the islet cell could survive for some time and continue to produce some insulin, but not enough for the patient to be able to stop taking insulin.
We wanted to do a clinical trial in the United States, so we submitted a proposal to the FDA and they requested we do primate experiments.

In monkeys, these capsules provoke a foreign body reaction, and it leads to a little bit of inflammation and to a small scar around the capsules themselves. That scar impedes the free exchange of nutrients and oxygen and ultimately the cells in the capsule die off.

We have established models in the laboratory and we can do the transplant and screen the transplant for materials that will cause that type of reaction.

The biggest impediment to moving forward with this research is financing it. This is very expensive research and there really is no way around doing it with primates. It is an experiment the primates tolerate very well. We insert empty capsules into their abdominal cavity and we do this as minimally invasive microscopic surgery.

We are not as advanced as we hoped. This is something that is working in mice but monkeys and humans are not reacting the same.

DiabetesCare.net: How would you characterize the importance of the encapsulation research versus the other projects you are working on?

Oberholzer: In both energy and finances, we spend equal parts on transplant clinical trials, the capsules, and making the islet cells grow. Therefore, this is a major project. If we can make encapsulation work, it will be a major medical breakthrough and would have consequences that go well beyond diabetes. It would resolve the problems of numerous diseases.

In next week’s Up Close, Dr. Oberholzer’s will provide his clinical perspective when treating patients who have an islet cell transplant.