proof of efficacy.
Dr John Court, a Diabetologist and Scientific Advisor to LCT, said, “This is only one patient’s experience but it does show that pig cells can survive at least 10 years in a micro-capsule coating and continue to release insulin into the patient’s bloodstream.”
LCT has significantly advanced the encapsulation process since the 1996 clinical trial and there is an even greater understanding and control over the longevity and robustness of the encapsulation process, as well as the porcine islet cells. The product is produced under a GMP manufacturing license.
LCT will be conduct trials of the DiabeCell pig islet cell transplant in patients in a phase I/IIa clinical trial in the second quarter of 2007. In addition, LCT is awaiting approval to conduct an additional trial in New Zealand this year with a different treatment protocol. Subsequent trials in the US or Europe are intended following initial results from these studies.
The trial will involve the simple injection of encapsulated neo-natal pig islet cells into them peritoneal (abdominal) cavity of the diabetic patients. The procedure is quite simple and carried out under local anesthetic. Patients will then be monitored by LCT’s well-established protocols, which are in accordance with international xenotransplantation guidelines.
“This is strong evidence that LCT’s DiabeCell product holds significant potential to address the key issues of finding renewable donor cells and not using immunosuppression, as outlined in the National Institutes of Health (USA) and Juvenile Diabetes Research Foundation (JDRF) strategic plans,” said Dr Paul Tan, LCT’s CEO.
“LCT’s clinical trial program intends to test three different treatment regimens, in order to find the most appropriate, long-lasting and effective transplant possible,” Dr Tan said.
DiabeCell is a porcine pancreatic cell product for the treatment of insulin
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