No More Insulin Injections
Procedure Offers Hope for Type I Diabetes

Last year, Jeanne Weido and Sue Wukoson had never met. This year, they are closely bonded, brought together as the first two Houston recipients of a revolutionary new procedure aimed at making diabetes patients free from daily insulin injections.

"We share a unique experience ... that makes us close, like family," said Weido.

Both women, who have Type I, or juvenile-onset diabetes, underwent an islet (pronounced eye-let) cell transplant – a procedure in which islet cells are removed from the pancreas of a deceased donor and implanted into a diabetic patient.

Islets are pancreas cells that produce the natural insulin that regulates how the body utilizes glucose, or sugar. When viewed under a microscope, they look like small clusters of islands, or isles, floating in a sea of other pancreas cells. In Type I diabetes, the immune system mistakenly attacks islet cells, leaving sufferers unable to produce necessary quantities of insulin. To counter this deficiency, patients self-administer multiple insulin shots each day.

Since childhood, Weido, 36, and Wukoson, 47, have taken as many as four insulin injections each day, worn bulky pumps designed to deliver measured doses of insulin, and carried glucose tablets on all outings to combat a "dip" in blood sugar, a phenomenon Wukoson likens to "suddenly falling off a cliff."

But with their surgeries, they’re free.

"I’m liberated. I can go anywhere, do anything. The burden has been lifted," said Wukoson, an interior designer who owned her own business until diabetes forced her to quit. Now she’s weighing career options and considering restarting her company.

Both women are participating in a clinical study conducted jointly by Baylor College of Medicine, The Methodist Hospital and the University of Miami, and approved by the U.S. Food and Drug Administration. In the study, eight individuals with Type 1 diabetes, in addition to Weido and Wukoson, will undergo islet cell transplants using a method called the "Edmonton protocol," developed at the University of Alberta in Edmonton, Canada two years ago, and first announced in the June 6, 2000 issue of the New England Journal of Medicine.

Here’s how the procedure plays out in the Houston study: First, a pancreas is secured from a donor who has suffered brain death. The pancreas is then transported immediately from Houston to the University of Miami Diabetes Research Institute, where the institute’s scientific director, Dr. Camillo Ricordi, and his team separate the islets from the surrounding tissue.

"The islet isolation laboratory at the University of Miami is the world’s best. That’s why we’re partnering with them. The success of a transplant relies heavily upon the expertise of the team performing the isolation," said Dr. Charles Brunicardi, chair of the surgery department at Baylor and chief of surgery at Methodist.

Typically, islets are cultured before transplant, but the Edmonton protocol uses freshly isolated islets. And while the Edmonton method calls for two donor pancreases to be used for a single patient in order to maximize the number of insulin- producing cells, each of the Houston patients required only one donor pancreas to achieve an optimal number of cells.

After being isolated, the islets are flown back to Houston within 18 hours from the moment the donor pancreas was first identified, and the transplant is performed in the Endovascular Center at The Methodist Hospital. Using X-rays as a guide, Dr. John Goss, principal investigator of the trial and a liver transplant surgeon at Methodist, injects the islets via catheter into the patient’s liver, where they lodge and begin producing insulin, just as they normally would in the pancreas.

"In essence, the liver now does the job the pancreas would normally do," said Dr. Goss, who also is an associate professor of surgery at Baylor College of Medicine.

Both Weido and Wukoson, whose surgeries were Jan. 17 and Feb. 8, respectively, began producing insulin on their own within 24 hours of their transplants. And three weeks after her surgery, Weido passed a glucose tolerance test with flying colors, proving that her body can successfully handle a heavy intake of sugar – a sure sign that her islets are working. Wukoson is slated to take the same test after spending time recovering from her surgery.

"So far the results are not only successful, but wildly successful," Dr. Brunicardi said.

Baylor and Methodist have received more than 700 phone calls in the past few weeks from individuals wanting to enroll in the trial, but at this point the study is limited to 10 patients who meet the participation criteria and have already been selected he said.

"Our hope is that the trial will be expanded to include more people once the results are known from the initial 10," Dr. Brunicardi said.

In undergoing this procedure, patients commit to a lifelong regimen of immunosuppresive drugs, the same as those taken by heart or liver transplant patients to prevent rejection of donor organs.

"After an islet cell transplant, the autoimmune destruction that led to the initial development of diabetes continues its attack on the new cells," Dr. Goss explained. "In addition, the body’s natural defenses go on full alert, recognizing the transplanted islets as a foreign invader and launching additional attacks. Patients are trading their insulin-dependent diabetes for becoming a transplant patient."

Still, the anti-rejection medication beats four shots a day, says Weido, a former pharmaceutical representative who for the first time in years feels well enough to return to work.

Unlike the immunosuppressive drugs of days gone by that contained steroids, the three drugs used in the Edmonton protocol are steroid-free.

"The lack of steroids is believed to contribute to the success of the Edmonton protocol, because steroids themselves may be toxic to newly transplanted islets," Dr. Brunicardi explained.

Just how successful islet transplantation for treatment of diabetes will be in the long run remains to be seen. Roughly 400 procedures have been performed worldwide since the first transplant in 1988, but until the development of the Edmonton protocol two years ago, the outcome was poor, with only 8 percent of patients becoming free from insulin injections. Transplants performed with the Edmonton protocol, however, are "stunning successes," Dr. Brunicardi says, with all patients to date remaining free of insulin.

"Still, we need about another 10 years to know the true success of the technique. The first patient transplanted with the Edmonton protocol is only two years post-surgery, and it’s possible that patients will need more than one transplant if their transplanted cells cease to function," he said.

Even if and when the Edmonton protocol is deemed a tried-and-true method for restoring the body’s normal insulin production levels, one problem still remains -– the lack of donor pancreases.

"One million patients in this country require insulin, but only 6,000 pancreases are available each year," said Dr. Goss, commending families who agree to organ donation. "It’s the ultimate act of kindness from a family that is having its worst day ever."

Currently, 10 centers around the nation are participating in a multicenter trial of the Edmonton protocol, including the University of Miami, where the Houston patients’ cells were isolated; the City of Hope National Medical Center and Beckman Research Institute in Duarte, Calif.; Columbia University’s College of Physicians and Surgeons in New York City; the Joslin Diabetes Center in Boston; Puget Sound Blood Center in Seattle; the University of Colorado Health Science Center in Denver; the University of Minnesota in Minneapolis; the University of Pennsylvania in Philadelphia; the University of Tennessee in Memphis; and Washington University in St. Louis.

Dr. Brunicardi hopes that after data from the initial Houston trial is completed, Houston will also be selected as a site, and considered for funding from such sources as the National Institutes of Health, the American Diabetes Association and the Juvenile Diabetes Research Foundation. Philanthropic efforts in the Houston community are currently supporting the trial, with each islet cell transplant costing between $150,000 and $300,000.

The cost is well justified, says Weido.

"I’m free, and that’s worth any amount of money. When I die years from now, it won’t be from diabetes."

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©2006 Texas Medical Center

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