From Living Cell Technologies www.lctglobal.com:
Living Cell Technologies Limited today announced that DIABECELL® was successfully implanted yesterday in the first patient with type 1 diabetes in Auckland, New Zealand.
DIABECELL®, LCT’s encapsulated porcine cells that produce insulin, was implanted by a laparoscopic procedure into the abdomen of a 47 year old man who has had type 1 diabetes for 20 years.
This is the first of eight DIABECELL® implants to be carried out under LCT’s clinical protocol for New Zealand. The protocol was approved by the Minister of Health in June 2009 following international peer review of LCT’s DIABECELL® clinical programme.
The patient was selected based on the protocol criteria for poor control of blood glucose. Despite meticulous specialist supervision of frequent daily insulin injections, he has continuing frequent episodes of high blood glucose, high glycated hemoglobin levels (HbA1c) and unacceptable swings including low blood glucose levels (hypoglycemia).
The trial is being conducted by Dr John Baker, principal investigator and diabetes specialist based at Middlemore Hospital in Auckland. The protocol requires patients to be monitored for 8 weeks before receiving the implant. The first four patients are to receive 10,000 islet equivalents per kilogram body weight (IEQ) of encapsulated pig islets and the next four patients the higher dose of 15,000 IEQ. All recipients of DIABECELL® implants will be followed up intensively for a year and less frequently thereafter. An independent Data Safety and Monitoring Board will assess progress and provide a report six months after the first implant. Details of the trial are available at www.ClinicalTrials.gov.
Dr Paul Tan, Chief Executive Officer LCT said, “The trial in New Zealand has attracted wide global attention with more than 200 reports in the international media. With positive results from our trial in Russia to date, LCT believes it may be able to deliver even better results for people with diabetes as this trial will be using higher doses.”
DIABECELL® is designed to normalize blood glucose levels in type 1 diabetes sufferers.
DIABECELL® comprises encapsulated porcine insulin-producing cells which can be administered without the need to use immunosuppressive drugs.
Type 1 diabetes occurs when the body’s own immune system destroys the insulin-producing cells of the pancreas (called beta cells). Five to 10 percent of the more than 200 million diabetics worldwide have insulin dependent type 1 diabetes. Type 1 diabetes is associated with kidney failure, blindness, nerve damage, life-threatening cardiovascular disease and limb amputations. Current treatment options include multiple daily injections of insulin.
For further information: www.lctglobal.com