In the next phase of this trial, four new patients will be given a higher dose of 15,000 IEQ/kg, by July 2010 with interim results due in October 2010 and final unblinding and reporting of results after one year follow up. LCT is now investigating the possibilities of conducting additional trials in other jurisdictions.
The protocol for the New Zealand trial of DIABECELL?® implants was approved by the NZ Minister of Health in June 2009 following international peer review of LCT's DIABECELL?® clinical programme. The protocol requires patients to be monitored for eight weeks before receiving the implant. All recipients of DIABECELL?® implants will be followed up intensively for a year and less frequently thereafter. Details of the trial are available at>
Insulin-dependent type I diabetes is caused by the autoimmune destruction of insulin producing cells. Presently, intensive treatment with insulin injections is necessary to normalize blood glucose to prevent future eye, kidney, nervous system and cardiovascular complications. Unfortunately, intensive insulin therapy causes swings in blood glucose levels and life threatening hypoglycaemic unawareness. The latter is a condition when no warning symptoms are felt when blood glucose falls to low levels that can impair consciousness resulting in accidents and coma. (www.diabetesnet and www.diabetesselfmanagement). Hypoglycaemic unawareness is related to the loss of the normal stress response to low blood glucose levels.
Source Living Cell Technologies
www.lctglobal