For those with type 1 diabetes, taking multiple injections of insulin every day or wearing a pump are parts of life. But varying levels of insulin can lead to low blood sugar, a life threatening condition, and for some, their only alternative is a pancreas transplant. Now, a new technique is giving these patients their lives back without the need for insulin.
Working out has always been a part of life for Rick Cataldi, but when he developed type 1 diabetes 15 years ago, wild blood sugar swings threatened to take his life.
Diabetes led to a massive heart attack and another scare later with his fiancé.
“She came over to the house and I was sitting there conscious, like comatose. My eyes were opened and foam was coming out of my mouth,” Rick told Ivanhoe.
Then, Rick found out about a new therapy involving insulin producing cells known as islets
“The red one is insulin, and these are very healthy islets,” Ali Naji, MD, PhD, Surgical Director of the Kidney and Pancreas Transplant Program at Penn Medicine, told Ivanhoe.
Lead investigator Dr. Ali Naji says the purified islets are injected into the patient’s liver where they settle and produce insulin.
“Then, they start to sense what the blood glucose level of the recipient is and they just precisely produce the right amount of insulin needed,” Dr. Naji said.
Now, two years after therapy, “I’m 100 percent off of insulin and I have perfect blood sugars, which is insane,” Rick said. “I can do basically anything better. It’s like I was a young man again.”
To optimize their function and the chances for a successful transplant, the donor islet cells are rested for three days prior to transplant. All patients in the study suffered with severe hypoglycemia unawareness—meaning they had no warning signs of low blood sugar. After their islet transplant, all patients were able to stop daily insulin injections, and have remained so for at least a year.
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Ali Naji, MD, PhD, Surgical Director of the Kidney and Pancreas Transplant Program at Penn Medicine, talks about a new therapy for type 1 diabetics.
Can you talk a little bit about these islet cells and how they can help folks with Type 1 diabetes and why they’re so important?
Dr. Naji: Some individuals with long standing type I diabetes develop a very severe complication called hypoglycemia unawareness. When the blood glucose is very low, the brain is deprived of its glucose metabolism and they can have seizure activities. So in a number of these patients their condition is so severe that they really need continuous attendance by other people to make sure that they don’t become hypoglycemic. Unfortunately, the hypoglycemia is induced by injection of insulin, which is the drug of choice for management of diabetes. And under these circumstances for these individuals with hypoglycemia unawareness, insulin has become a very dangerous drug for them.
Could you talk a little bit about the trial and how these islet cells are helping these patients avoid transplants?
Dr. Naji: One of the intrinsic characteristics of the islet cells are that they respond to the level of glucose in the blood. So if the level of glucose is high, they just produce the right amount of insulin to get it to normal level. And if it goes down, it shuts down these cells that produce insulin. So, in a normal individual, the excretion of glucose is very tightly regulated; regardless of our physical activity or what we eat. However in an individual with type I diabetes who does not have beta cells to produce a regulated insulin response, they rely on injections of insulin under the skin. But, the absorption and the impact of the glucose is variable. So you can have certain periods of time that the glucose is within normal limits. But in many occasions during the 24 hour profile you have very high or very low glucose levels. Those highs and lows are dangerous, and also detrimental to the metabolism of other cells in the body such as the eyes, the brain and the kidneys. Ultimately one of the complications of long-term diabetes is micro vascular disease where small tiny vessels in most of these organs are damaged, and unfortunately it leads to blindness, loss of the kidney, heart attack, stroke, or amputations.
How do these islet cells offer an alternative to the insulin?
Dr. Naji: For individuals who have or are suffering from severe imbalance of glucose metabolism or hyperglycemia unawareness, transplanting normal islets would allow them to regulate their blood glucose in a way that a normal individual does. They don’t go through this severe excursion of glucose and they would not be put in the hazardous danger of becoming hypoglycemic and having complications later from the hypoglycemia. What it provides is the normal, precise control of the blood glucose in individuals who have undergone the transplantation. In successful islet transplantation, the individuals are completely off insulin. They don’t have the exogenous administration of insulin on a daily basis.
Islet transplantation isn’t really new, but the new component of this is leaving them for three days?
Dr. Naji: Right. The concept of islet transplantation has been tested for about three decades. Within the three decades many improvements have been made, from moving this promising therapy from rodent models to human clinical trials. Many advances have been done. One of them, which is very important, is the ability of automating the isolation of human islets in a specific facility. Another is the ability to procure very viable and healthy human islets. Finally, the simple technique of injecting islets into the liver of the recipients has been really a remarkable and encouraging innovative therapy that has come within less than a decade. All these advances really have happened in about 10 years.
Once you inject islets into the liver, then that’s going allow the body’s own response to kick in?
Dr. Naji: Exactly. So, what happens after the injection of islets into the liver, the islets take a route into the liver sinusoids and they get new capillaries. They have blood supply, and they have oxygen supply, and then they start to sense the blood glucose level of the recipient and they precisely produce the right amount of insulin needed to keep the blood glucose within the normal range.
How big of a breakthrough do you think this is in the medical community?
Dr. Naji: I believe the course of islet transplantation as an attractive therapy for type I diabetes has gone through milestones. I believe the current trial, which was supported and funded by the National Institutes of Health, is really the first time that a clinical trial has taken place, with all its regulatory elements. And in fact I think that tremendous credit goes to the FDA and the National Institutes of Health to be able to initiate these trials among a number of academic centers in the United States, and also in Canada. I believe the current trial in itself is a milestone, but the momentum of islet transplantation continues. We are not where we want to be. We have made significant progress but we have many miles still to go.
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