From Living Cell Technologies (LCT) Newsletter:
(More info about Living Cell Technologies: www.lctglobal.com)
First Patient Drops Insulin Dose In New Zealand DIABECELL® Trial
LCT is pleased to refer you to the report from Dr John Baker, diabetes specialist conducting the DIABECELL® clinical trial in New Zealand. The report was released today in response to numerous queries from the public on the progress of the trial. Dr Baker reported that there were no ill effects and the patient has dropped his dose of insulin by 30% while maintaining his usual blood glucose level. Prof Bob Elliott, LCT Medical Director says that the trial is still at a very early stage and he is pleased to see the patient respond to the implant as expected.
The next person is another man who is now scheduled for the implant in December. Four more candidates have been identified. Although only 8 candidates are required for the trial, the selection procedure is intensive.
All candidates must meet the selection criteria approved by the Regional Ethics Committee and Medsafe, the regulatory authority of the Ministry of Health. All are adults who have had diabetes for at least 5 years that is difficult to control or ‘brittle’ despite careful monitoring of blood glucose, insulin doses and lifestyle. They all have swings in blood glucose levels and frequent episodes of unacceptably low blood glucose.
Frequently Asked Questions on Availability of DIABECELL®
When is DIABECELL® likely to become available as a treatment?
LCT is targeting to get DIABECELL® registered as a human therapeutic by the end of 2012 so that it will be available as a treatment for insulin dependent type 1 diabetes.
Why does it take till 2012?
DIABECELL® has to be shown to be safe and effective in clinical trials approved by regulatory authorities. These trials are expected to continue to 2012. The treatment involves a surgical procedure and a clinical trial of 50 patients implanted with DIABECELL® is expected to be sufficient to obtain ‘pivotal data’ required by regulatory authorities before allowing the treatment to become available.
Where will DIABECELL® be available?
A new treatment is usually first available in a country that has done clinical trials, and to date the trials have been conducted in Russia and New Zealand.
How would a person with diabetes get this treatment from LCT?
DIABECELL® will be available from a few medical centres authorized or licensed by LCT. Staff at these centres will be trained to provide treatment with DIABECELL®. Patients will have to be referred to the medical centre by their doctor.
LCT or its commercial partner is to manufacture DIABECELL® and provide the encapsulated pig cells to the medical centre and not directly to the patient.