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Clinical Trial called “first step” in evaluating new therapy
Los Angeles, CA, May 13, 1993 - The first encapsulated pancreatic islet cell transplant in humans was reported today by physician scientists of the National Institute of Transplantation at St. Vincent Medical Center, Los Angeles.
"This clinical trial in humans is the first step in evaluating the potential of encapsulated islets as a new therapy for treating the estimated 1.4 million insulin dependent diabetics in the US," said Patrick Soon-Shiong, MD. "Although the transplant of encapsulated pancreatic cells has successfully reversed diabetes in animal research studies, we have much to learn about the application of this technique in humans."
The transplant recipient is Steven Craig, 38, of Lake Isabella, CA. Craig, who has suffered from insulin-dependent diabetes for over 30 years, underwent minimally-invasive surgery to receive the encapsulated islet cells on Thursday morning, May 6. During the transplant, a solution containing 680,000 encapsulated islet cells from donated cadaveric pancreata was placed free-floating into his peritoneum, or abdominal cavity. The cells are encapsulated in a thin microfilm bubble of alginate extracted from seaweed.
"It is premature to state when this procedure could be considered a clinical treatment," Dr. Soon-Shiong said. "Only when we have fully evaluated the results will we know the true potential of the therapy." Patients selected for Dr. Soon-Shiong's continuing investigations will be those who demonstrate end-stage kidney disease and have had a kidney transplant.
In his animal research studies, Dr. Soon-Shiong reported long-term islet function in five dog recipients of encapsulated islets. Graft survival ranges from 228 to 641 days in four dogs receiving multiple transplants, and for as long as 726 days in the fifth recipient which received a single transplant.
"Despite insulin therapy, major life-threatening and debilitating complications of diabetes still persist," Dr. Soon-Shiong stressed. "Our first recipient, Steven Craig, has suffered from eye problems as well as nerve damage in his lower extremities and kidney failure. The challenge we as physicians face is to intervene before these secondary complications take their toll. Encapsulated islet cells may be a step in that direction."
0 comments - Jun 1, 1993
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