Life-changing cellular therapy for Type 1 diabetes.
The treatment involves introducing encapsulated porcine cells into the abdominal cavity of the patient in a simple laparoscopic procedure. LCT’s unique proprietary encapsulation technology means that this procedure does not require the use of immunosuppression.
LCT is conducting Phase IIb clinical trials in New Zealand and Argentina on behalf of Diatranz Otsuka Limited, a joint venture company formed with Otsuka Pharmaceutical Factory Inc. The long-term safety of DIABECELL has been demonstrated in at least one patient whose implanted cells are still producing insulin after more than 10 years.
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- Diabetes is the world’s fastest growing chronic disease that affects 346 million people worldwide and the World Health Organisation predicts diabetes deaths will likely increase by more than 50% in the next 10 years.
- Type 1 diabetes represents an estimated 10% of all diabetes cases.
- In Australia, diabetes is the sixth leading cause of death.
- 890,000 Australians are currently diagnosed with diabetes. Total number (diagnosed and undiagnosed) of Australians with diabetes is estimated to be 1.7 million people.
- 275 new cases of diabetes develop every day in Australia
- More than 80% of diabetes deaths occur in low- and middle-income countries.
- The World Health Organisation (WHO) projects that diabetes deaths will double between 2005 and 2030.
- In 2007, diabetes cost the US economy $174 billion and it is estimated that one in every 10 health dollars in the US is spent on diabetes.
- WHO estimates that 2.5 to 15% of annual health budgets are spent on diabetes-related illnesses.
A Phase II DIABECELL trial has commenced in Argentina. Four patients will receive 2 implants of 5,000 islets per kilogram body weight, each implant three months apart. The dose for the second four will be decided after the outcome of the first four is known.
A Phase II trial with DIABECELL is being carried out at Middlemore Hospital in Auckland. Under the trial guidelines, 14 patients with unstable type 1 diabetes have been treated and are now being monitored. The first four patients received 10,000 islet equivalents per kilogram body weight (IEQ), the next four 15,000, two 20,000 and four 5,000.
This trial builds on an earlier Russian Phase I/IIa trial, conducted in 2007 – 2010, which met its endpoints for safety and proof of principle for efficacy in human.
LCT conducted a Phase I/IIa clinical trial in Russia. A total of 9 patients received DIABECELL implants of varying dose strength. Some patients received multiple doses.
Data analysis to date has confirmed that the trial successfully met its endpoints of demonstrating safety and tolerability. In addition, the trial showed proof of principle of efficacy in humans with insulin-dependent (Type 1) diabetes.
Six of the eight patients on the trial demonstrated improvements in blood glucose control as reflected by reduction in glycated haemoglobin (HbA1c %) levels and reduction of the required daily dose of insulin injections. Two patients discontinued insulin injections entirely for up to 32 weeks.