16-year-old West Fargo girl among handful of kids in Sanford trial seeking diabetes cure
WEST FARGO -- Karissa Driscoll at first credited her weight loss to a new diet. But it turned out to be the beginning of a rapid downward spiral. Not long after welcoming the loss of eight pounds -- which would help lighten her step on the volley...
WEST FARGO -- Karissa Driscoll at first credited her weight loss to a new diet. But it turned out to be the beginning of a rapid downward spiral.
Not long after welcoming the loss of eight pounds -- which would help lighten her step on the volleyball court -- the 16-year-old became breathless merely walking up and down the stairs.
Her sister, who came home for a holiday visit, remarked about her dramatic weight loss. She often became fatigued, requiring naps.
"That's not her at all," said her mother, Tami Wellman.
One Saturday in early January, as the severity of Karissa's symptoms progressed, she took her daughter to the emergency room.
A blood test identified the problem. Her blood glucose level was more than 500, far above the 80 to 150 range considered normal. Karissa discovered that she had diabetes.
"I was really surprised," she said.
She was so dehydrated that her veins had collapsed; she was admitted to Sanford Medical Center for two days.
Not long after, the student at West Fargo's Sheyenne High School learned she qualified for a new study, a trial at Sanford to test a new immunotherapy for juvenile type 1 diabetes.
Type 1 diabetes, which mostly strikes children, is an autoimmune disease. The body's immune system attacks the insulin-producing cells in the pancreas, causing diabetes.
The Sanford Project, a research initiative to find a cure for diabetes, recently launched what it calls its T-Rex study, a trial to test a therapy that uses patient's immune system to combat the disease.
"This is one of several approaches that we're investigating," said David Pearce, president of Sanford Research, based in Sioux Falls, S.D. "Our thought was this is the most cutting edge approach right now."
Last week, Pearce spoke about the T-Rex study at a Vatican conference about regenerative medicine in Rome. Sanford was recognized for its research with the Pontifical Key Innovation Award.
The treatment involves drawing the patient's blood and isolating what are called T-regulatory cells, which control the immune system. The sample is sent to Caladrius Biosciences, a California biotech firm and Sanford's partner in the research.
At the lab at Caladrius, the T-regulatory cells are multiplied, then infused into the patient's bloodstream in the hope they will calm the immune system to spare the pancreas from further damage.
Karissa is one of seven pediatric diabetes patients in Sanford's Fargo region taking part in the study. To qualify for the study, the patient's pancreas still must have the ability to produce some insulin.
"We have a high prevalence (of type 1 diabetes) here in North Dakota and Minnesota," said Dr. Luis Casa, a pediatric endocrinologist who is a principal investigator in the study.
The disease is most prevalent in Scandinavian countries and among those of Scandinavian descent.
"We're seeing more cases than ever before," Casas said, adding that researchers and clinicians can only speculate on the reasons. Sanford researchers hope to expand the T-Rex study to more than 100 patients at 15 sites around the country.
The T-Rex study is open to type 1 diabetics 12 to 17 years of age who were diagnosed no more than 100 days before enrolling -- a time limit Karissa considers herself fortunate to have met.
"I guess if you have to get diabetes now is the time to do it," Tami said.
Karissa doesn't know if she was given a therapeutic dose or a placebo. Doctors and researchers hope to get some indication of whether the therapy is working in about 91 days.
Meanwhile, how does it feel to be a subject in a research trial?
"To me, I think it's kind of scary," Karissa said. There is the nagging uncertainty of whether she got the treated blood or placebo, which has no therapeutic effect.
Regardless of the outcome, there is some consolation in knowing that she will have helped advance scientific knowledge. "If it doesn't work on you," Karissa said, "you can help other people."
The uncertainty also gnaws a bit at Tami, who clutches to a mother's hope. "Time will tell," she said. "And everything is crossed."