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Life-changing cellular therapy for type 1 diabetes.

DIABECELL® is a porcine, insulin-producing cell product for the treatment of type 1 diabetes. These islet cells are self-regulating and efficiently secrete insulin in the patient’s body.

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.

Clinical Trials

DIABECELL is currently in a late-stage clinical trial: A 30 patient registration study with a combined endpoint of reduction in unaware hypoglycaemia with no increase in HbA1c. 20 patients for this registration study will be provided from the trial currently ongoing in Argentina (announced as a Phase IIb on 22 November 2012). All 20 patients have been recruited, and at 30 June, 16 implants have been performed. The remaining 10 patients will be recruited in New Zealand once the application for the registration study is accepted by the New Zealand regulators Medsafe, which is expected to occur before the end of 2013.

Click here for information on the NZ trial

Product Demand

Around 8 million adults worldwide suffer from type 1 diabetes. The current total market for injected insulin is approximately A$2 billion p.a.

Product Development

Phase IIa safety and efficacy study (Argentina)
The trial, which is ongoing, involves eight patients split into two groups of four. Group one received two 5,000 IEQ/kg doses of DIABECELL (islet equivalents per kilogram of body weight). Group two received two 10,000 IEQ/kg doses of DIABECELL. In both groups, the second dose was implanted 12 weeks after the first.

Results of the interim analysis were announced in November 2012. At the time of the interim analysis, group one patients were at 24 weeks follow-up after the second transplant, and group two patients were at 12 weeks follow-up after the second transplant.

The results clearly demonstrated a clinically significant reduction in HbA1c, insulin dose and unaware hypoglycaemia, with greater benefit being seen in the patient group receiving the higher dose of DIABECELL. The most significant clinical benefits were:
  • average insulin dose reduced by 20%
  • a reduction of HbA1c from a pre-transplant average of 8.6% to an average of 6.7% at 12 weeks following the second implant
  • up to 70% reduction in unaware hypoglycaemic events.

This interim analysis was used to inform the 30 patient registration study.

Final results from the Phase IIa study in Argentina are expected to be released in the third quarter of 2013.

Phase IIa dose finding study (New Zealand)
A total of 14 patients at with type 1 diabetes were treated at Middlemore Hospital in Auckland and completed the trial. Patients were treated with different levels of islet cells: 5,000, 10,000, 15,000 and 20,000 IEQ/kg body weight. At 52 weeks, HbA1C levels were reduced in the 5,000, 10,000 and 20,0000 IEQ/kg treatment groups, compared with baseline. A statistically significant reduction in the number of unaware hypoglycaemic episodes was observed in both the 5,000 and 10,000 IEQ/kg groups. A reduction in insulin use was evident in all treatment groups, with marked mean reductions in the 5,000 and 10,000 IEQ/kg groups. The islet cell implants were well tolerated in all patients. Quality of life questionnaires revealed a positive impact of treatment.

This trial builds on an earlier Phase I/IIa trial in Russia, conducted in 2007–2010, which met its endpoints for safety and proof of principle for efficacy in humans.

Phase I/IIa safety study (Russia)
A total of eight 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.