Chris Schuh, 66, of Tallahassee, has suffered from Type 1 diabetes and hypoglycemia since she was 30.
She says she wouldn’t be alive right now if it weren’t for a life-changing procedure that enabled her body to produce insulin.
“My life was in jeopardy on a daily basis,” she said of life before pancreatic islet transplantation, which was done at Jackson Memorial Hospital by Dr. Camillo Ricordi and his team from the Diabetes Research Institute (DRI) and Cell Transplant Center at the University of Miami.
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“I didn’t think I’d live to see my daughter graduate from high school,” she said. “I’m alive because of those transplants.”
Ricordi, the director of the DRI’s Cell Transplant Center, is one of the world’s leading scientists in diabetes cure-focused research and cell transplantation. Thirty years ago he invented a device that isolates large numbers of insulin-producing islet cells, using the healthy pancreas of an organ donor. The cells can then be transferred into the liver of a patient with Type 1 diabetes via a transfusion.
“If you take islets from a donor who did not have diabetes and who was producing insulin,” said Ricordi, “you have live cells that are free from contamination, which is safe to transplant.
“They will produce a biologic function — as we have shown in this Phase 3 trial, which lasted over 10 years.”
In the Phase 3 trial, around 50 patients underwent islet transplantation and were monitored over the trial’s time span. More than 1,000 islet transplants have already been performed in Europe, Canada, Australia, and Asia, where the procedure is authorized. It’s currently awaiting FDA approval in the United States.
“If the FDA grants us approval of islets transplantation,” Ricordi said, “we will be able to serve patients in the US.”
The procedure, called the Ricordi Method, is used to treat Type 1 diabetes patients who suffer from hypoglycemia., or low blood sugar levels.
Before learning about islet transplantation, Schuh said she tried to do everything right in maintaining a healthy lifestyle, from eating healthy to exercising.
“I was the casebook classic case of doing everything right,” she said, “and nothing worked.”
In those with Type 1 diabetes, which often afflicts teens and young adults, the pancreas stops producing insulin. Type 1 diabetics require insulin injections in order to stabilize their blood sugar since they make little or no insulin.
Schuh, who says diabetes runs in her family, received two infusions of the insulin-producing cells from Ricordi and his team — one in 2002 and another in 2006. She was off insulin for all but four months after the first transplant and has been completely off insulin since the second transplant.
She first learned about the trial offered at the Diabetes Research Institute from reading a publication about diabetes while sitting in her doctor’s office in Tallahassee.
“I asked my doctor what he thought, and he said, ‘You’ve got nothing to lose!’ ’’
Schuh also suffered from hypoglycemia unawareness and was unable to detect the warning signs of her blood sugar dropping. This can lead to fainting or even seizures.
“I didn’t really understand how fragile I was,” she said. “I’d have to pull over to the side of the road and the police would find me, just sitting in my car with the motor running. I’d try and jump out of the window in the middle of the night. I had no conscious recollection of any of this,” she said. “That’s what your body does when your mind isn’t functioning properly.”
Today, her life is completely different, she said.
“It took me a long time to stop testing my blood six to ten times a day — probably 10 years after the transplants to stop doing that — because you just don’t believe it.”
Physical labor like gardening will still drop her blood sugar, she said, but she can detect it now and will get something to drink or eat to raise her levels.
“It’s worked incredibly well for me,” she says of transplants. “You’re in a semi-conscious state when they infuse the cells into you,” she said of the outpatient procedure.
Ricordi, who was born in New York and raised in Italy, developed the method for the automated procedure in 1986, while working in the laboratory of Dr. Paul Lacy, at Washington University in St. Louis.
The first islet transplantation was done in 1990 after Ricordi was recruited to the University of Pittsburgh’s Thomas E. Starzl Transplantation Institute. He was recruited to the University of Miami in 1993, where he’s remained.
Schuh and others who’ve had the procedure must take immunosuppressive drugs daily to prevent transplant rejection. The drugs reduce the strength of the body’s immune system but make the body less likely to reject the transplant.
Schuh gets her blood monitored every three months. She saw her daughter graduate from high school and then law school. And she’s now a grandmother to a 19 month-old baby girl.
She credits Ricordi and his team with saving her life and countless others.
“Dr. Ricordi developed the device and the procedure and taught everyone else how to filter out those islet cells from a cadaver,” she said. “Those people have advanced the search for the cure of diabetes considerably.”
In 2001, Ricordi was awarded the Nessim Habif World Prize in Surgery (University of Geneva) for developing a technology “that significantly contributed to the advancement of a surgical field.”
The following year, he was awarded the Outstanding Scientific Achievement Award by the American Diabetes Association.
The Ricordi Method is open-access, meaning the invention is free of intellectual property rights and is freely distributed and provided to investigators and clinical centers worldwide.
“Miami’s been at the core of making this technology available worldwide,” Ricordi said.
His most recent work with the DRI team involves a new technology called the DRI BioHub, a bioengineered mini-organ that mimics the pancreas to restore natural insulin production in those with Type 1 diabetes.
It was created to minimize the inflammatory reaction that happens when islets are implanted in the liver or in other sites with sudden contact to the blood. If these results are successful, it can pave the way for islet transplantation without immunosuppression drugs.
“Eventually we want to bring islet transplantation to all patients with Type 1 diabetes and eventually even to patients with Type 2 diabetes who require insulin,” Ricordi said. “We’re working hard to decrease the need for anti-rejection drugs and eventually be able to do this transplant without using anti-rejection drugs,” he says.