Cell Therapy Supported by Bioethics Recommendation
Cell Therapy Supported Through Bioethics Recommendation
AUCKLAND, Dec. 14 /MediaNet International-AsiaNet/ --
Living Cell Technologies (ASX: LCT) welcomes the final recommendation by Toi te Taiao: the Bioethics Council, that xenotransplantation should be allowed to develop in New Zealand.
The Bioethics Council report entitled ‘The Cultural, Spiritual and Ethical Aspects of Animal-to-Human Transplantation’ presents final recommendations to the New Zealand Minister for Environment after a year of public consultation and ethical review.
“The principal recommendation is a further positive step for cell therapy, as it continues to open the path to market for xeno-based therapies,” said Mr David Collinson, CEO, Living Cell Technologies Ltd.
LCT also welcomes the Council’s recommendation for the implementation of an appropriate regulatory and decision-making framework, as well as appropriate measures to ensure that all xenotransplantation research is conducted under these guidelines.
“LCT has developed its technology in line with the rigorous xenotransplantation guidelines administered by the US FDA and we would welcome New Zealand providing a similar, positive role to guide the development of xeno-based therapies.”
The Bioethics Council was established in 2002 to consider the cultural, ethical and spiritual issues raised by biotechnology. During the year, the Council has conducted a dialogue on animal to human transplantations, through open submissions, an online forum and a series of dialogue meetings. The report released today is a reflection of these discussions.
The Bioethics council recommendation follows LCT’s meeting with the US Food and Drug Administration (FDA) to discuss the pre-clinical data, research data, manufacturing and clinical trial strategy for its first cell therapy product, NeurotrophinCell.
“The meeting with the FDA was very positive, we have a clearly defined path to move forward and have no doubts on our ability to take our products to the clinic.”
Details of the meeting will be disclosed upon receipt of the meeting minutes.
“The legislative and regulatory environment is opening up to the potential of cell therapy, as a viable and accessible treatment for today,” said Mr Collinson.
About Living Cell Technologies: www.lctglobal.com
Living Cell Technologies Ltd (ASX: LCT) develops live cell therapy products to treat life threatening human diseases such as Huntington’s disease, insulin-dependent diabetes and haemophilia.
Further information / background brief:
What is xenotransplantation?
In medicine, xenotransplantation is the use of living non-human animal cells, tissues or organs to treat humans. Transplantation of tissues, such as bone marrow, or clusters of specialised cells, such as pancreatic islet cells are known as cell therapies.