I, Tony Ryall, Minister of Health, pursuant to section 96C(4) of the Medicines Act 1981 ("the Act"), hereby vary the conditional authorisation, issued under section 96C(1)
of the Act to Living Cell Technologies Limited (LCT) and dated the 22nd day of June 2009*, to conduct a clinical trial involving xenotransplantation.
That authorisation is hereby varied in the following respects:
1. The protocol is amended as follows:
1.1 LCT is allowed to increase the number of participants in the study to 12.
1.2 LCT is allowed to increase the maximum dose of Diabecell that is to be administered to the four additional participants to 20,000 IEQ/kg.
1.3 LCT is required to introduce a further safety review by the Data Safety Monitoring Group before commencing administration of Diabecell 20,000 IEQ/kg to the four additional participants.
1.4 LCT is permitted to tighten the manufacturing specifications of Diabecell as described in LCT’s application to Medsafe dated the 21st day May 2010.
1.5 LCT is required to conduct additional testing for minor inflammatory responses post-transplantation.
1.6 LCT is permitted to improve the scoring system used to assess hypoglycaemia in patients as described in LCT’s application to Medsafe dated the 21st day May 2010.
2. Condition added:
2.1. LCT will, prior to implementing the amended protocol, provide Medsafe with evidence that the Northern X Regional Health and Disability Ethics committee has considered and approved LCT’s proposed amendments contained in its application to Medsafe dated 21 May 2010.
All previous conditions instituted in the authorisation issued to LCT dated the 22nd day June 2009* remain in effect for the period that the clinical trial has been approved
by the Northern X Regional Health and Disability Ethics Committee, unless sooner varied or revoked, pursuant to section 96C(4) of the Medicines Act 1981.
Dated this 20th day of July 2010.
HON TONY RYALL, Minister of Health.
*New Zealand Gazette, 25 June 2009, No. 94, page 2111