G'day LCT gang,the National Health Committee has issued the...

G'day LCT gang,

the National Health Committee has issued the following press release relating to the Consultation on application by Living Cell Technologies:

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The Minister of Health has asked the National Health Committee to provide him with independent advice on an application by Living Cell Technologies (LCT) to conduct a clinical trial of pig cell transplantation in New Zealand.

The National Health Committee is inviting written public submissions on the proposed trial and whether it meets the criteria set out under Section 96E(1) of the Medicines Act 1981. The closing date for public submissions is Friday 25 July 2008.

This consultation relates only to the application made by LCT for this particular trial; it is not a more general consultation about xenotransplantation.

Reason for consultation

Living Cell Technologies Pty Limited (LCT) has applied to the Minister of Health to conduct a clinical trial of pig cell transplantation in New Zealand. The trial involves inserting pancreatic cells from pigs into eight people with type 1 diabetes, to test whether the cells will produce insulin, thus reducing or eliminating the need for these people to use injected insulin.

The trial is limited to testing the safety of the procedure for the patients, and will give early indications of whether the treatment is likely to be effective.

The National Health Committee has been asked to provide advice on whether the trial meets the criteria under Section 96E(1) of the Medicines Act 1981, which are that:

the conduct of the procedure or class of procedure does not pose an unacceptable risk to the health or safety of the public
any risks posed by the conduct of the procedure or class of procedure will be appropriately managed
any ethical issues have been adequately addressed
any cultural issues have been adequately addressed
any spiritual issues have been adequately addressed.

The National Health Committee is particularly interested to receive submissions from persons with type 1 diabetes, and anyone with expertise in the field of xenotransplantation and related fields.



How to make a submission

Submissions close on Friday 25 July.

Download from the Consultation Document on application by Living Cell Technologies (PDF, 65 KB)

If you would like to be sent a submission document, please phone 0800 990 028 or email [email protected].

If you wish to make a submission, you can do any one of the following:

Post your submission to:

LCT Application Submission
National Health Committee
PO Box 5013
WELLINGTON.

Hand deliver your written submission, in an envelope marked

“LCT Application Submission, National Health Committee”.
to
Ministry of Health offices
Level 2
No 1 The Terrace
WELLINGTON.

Fax your submission to
04 496 2191, attention “National Health Committee”

Email your submission, with the title “LCT Application Submission to
[email protected].

If for any reason you are unable to make a written submission, but would like your views to be conveyed to the NHC, please call toll free on 0800 990 028 as soon as possible.

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The link for the release is as follows:
http://www.nhc.health.govt.nz/moh.nsf/indexcm/nhc-news-consultationapplicationlivingcelltechnologies


Cheers

SW