Islet Cell Transplants Improve Quality of Life
Type 1 diabetes who disease has advanced to the severe, or "brittle," stage experience total blackouts without warning. The episodes can occur at any time or any place. Patients with hypoglycemia unawareness live in constant fear of losing consciousness – while out in public, playing with their children, even while driving.
Luis Fernandez, MD, assistant professor of surgery in the Division of Organ Transplantation at the University of Wisconsin School of Medicine and Public Health, has performed islet cell transplants for the past six years and has noted a marked improvement in the quality of life for patients who undergo this procedure.
"The important thing to emphasize here is quality of life," Fernandez says. "It has improved significantly compared to (life) before the transplant."
"The stories of these people are so dramatic. This is a life-saving procedure for them."
Fernandez says the success rate at UW for islet cell transplantation is 75 percent insulin independence at one year and 50 percent insulin independence at two years. Even if patients have to go back to insulin after a period of time following islet transplantation, Fernandez says they require much less insulin than before the transplant and are much better off.
He adds that there is a 100 percent resolution of hypoglycemia unawareness – no more fear of blacking out.
Islet cell transplantation has come a long way since the early 1990s. From 1990 to 1999, only 8 percent of the transplants resulted in insulin independence for more than a year. In 2000, a group of researchers at the University of Alberta in Edmonton altered the therapy, transplanting a higher number of islet cells and using a different immunosuppressive regimen. The work become known as the "Edmonton Protocol" and the success rate continues to improve.
Hemoglobin A1c is used a surrogate marker of how good a patient's glucose control has been over the past three months. Less than six percent is considered outstanding glycemic control. Patients transplanted at UW have a hemoglobin A1c of 5.8 percent at two years after their transplant. A low hemoglobin A1c indicates that there is a much lower risk for secondary complications related to diabetes. If an individual has a hemoglovin A1c of less than 6.5 percent, the chance that he or she will have problems with their eyes, kidneys, heart or nerves is greatly reduced.
Of the ten patients who have undergone islet cell transplants at UW Hospital, three – soon to be four – have maintained insulin independence for more than two years. Others are being monitored, since the UW trial is still in a preliminary phase.
Currently, a family member cannot donate islet cells, since the entire pancreas must be used to recover enough islets for successful transplantation. Fernandez and his group hope that their ongoing research will allow them in the future to optimize the recovery of islets so that a partial pancreas will yield enough quantity to guarantee a successful long-term transplant.
Islet cell transplantation is a minimally invasive procedure with no surgery involved. Islets are recovered from a deceased-donor pancreas and are either injected directly into the portal vein of the liver or via a small incision. Fernandez says he maintains a conversation with the patient while he or she is undergoing the 30-45 minute procedure. The patient is hospitalized overnight to monitor glucose control and is sent home the following day.
The goal is to inject sufficient islets to the patient will begin producing enough insulin to maintain a normal blood sugar level without need for insulin injections. Multiple islet cell transplants are sometime needed, and recipients will be on immunosuppressive drugs for the rest of their lives.
Because islet cell transplantation is a tradeoff of insulin for anti-rejection medications, Fernandez says this option is the treatment of choice for only Type 1 patients who have reached a level of poor glycemic control and have hypoglycemic unawareness.
Another group of patients who benefit from islet cell transplantation are Type 1 diabetics who have already had a kidney or liver transplant. For these patients, who are already using immunosuppressive therapy, the inclusion criteria for islet transplantation is not as strict, since they will not be required to change their current immunosuppressive medications to maintain a successful islet cell transplant.
One of Fernandez's patients suffered seizures every day; paramedics knew her on a first-name basis. After having an islet cell transplantation, she has not had a seizure or seen a paramedic for three years.
"She's doing terrific," says Fernandez. "Her glucose control is just absolutely outstanding."
Islet cell transplantation is still considered an experimental procedure, so it is not covered by insurance companies or Medicare. Funding is provided in part by grants from the National Institutes of Health and from private sources. Fernandez says UW Hospital also has helped to offset the procedure's cost "because they believe in this therapy. The patients are clearly alive because of this procedure, and they support any initiative that translates into a healthier community."
The UW Division of Transplantation has a team dedicated to determining the patients' candidacy for islet transplantation and answering any questions involving the therapy.
"I never though that doing islet cell transplantation could actually save a person's life," says Fernandez. "And this is where we are now."
Fernandez also has used islet cell transplantation for patients suffering from chronic pancreatitis. In that procedure, a patient's pancreas is removed and their own islet cells are recovered and injected into the patient's liver to prevent development of diabetes and relieve intractable pain. Since the patient's own islet cells are used, there is no need for immunosuppressive drugs.
"The success has been wonderful," says Fernandez. "These are people who have been taking an amount of narcotic that is sufficient enough to kill you or me together. And they take it on a daily basis."
Fernandez reports 100 percent resolution of pain in these patients. And about 50 percent of them no longer need insulin therapy. "So it's quite successful," he says.
Learn more about the Islet Cell Transplant Program at UW Health