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Stem Cell Bank

Genea Biocells developed one of the world’s largest banks of diverse, ethically derived, NIH approved human embryonic stem cell lines. Our sister company, Genea Fertility, is a world leading IVF clinic in Australia that gives patients the option to donate access and disease-affected embryos to research and stem cell derivation. Our bank now contains:

>150 lines many of which are approved by the NIH and the UK-SCB

Disease affected cell lines from PGD embryos with 30 different diseases

For more information on individual lines visit our product catalogue.

Our cell banking follows international practices with a safety bank of vitrified stocks expanded by manual passaging on human feeder cells and a working bank expanded by a proprietary feeder-free method. All frozen stocks are fully quality controlled using state-of-the-art stem cell banking practices:

Viability, morphology, attachment and proliferation post thawing

Mycoplasma and sterility

DNA fingerprinting

Karyotype (CGH microarray)

Pluripotency marker expression (HCS)

In vivo pluripotency (teratoma replaced by Pluritest)

RFID tagging of cryovials

Ethical Governance

 

Research activities involving humans or human material are performed under close supervision by an institutional Human Ethics Committee (HREC).

All research projects are assessed for compliance with Australian and international guidelines for human embryo and stem cell research:

Australian Ethical Guidelines on the use of Assisted Reproductive Technology in Clinical Practice and Research

Australian National Statement on Ethical Conduct in Human Research

US National Academy of Sciences (NAS) Guidelines for Human Embryonic Stem Cell Research

US National Institute of Health (NIH) Guidelines for Research using Human Stem Cells

UK Stem Cell Bank Steering Committee Code of Practice for Use of Human Stem Cell Lines

The Genea Human Research Ethics Committee (NHMRC registration number EC00289) is composed predominantly of men and women who are independent of the company and who are pre-eminent in the community. This includes lay people, members with current scientific expertise in the areas of research considered by the HREC, counseling and treatment of people, lawyers and clerical representatives. The Committee’s membership composition is in accordance with the requirements of the National Health and Medical Research Council (NHMRC) to fulfill all functions required of an institutional Human Research Ethics Committee.

Regulatory Governance

Human embryo research in Australia is subject to regulation through the Research Involving Human Embryos Act 2002 (Cth) and the Prohibition of Human Cloning Act 2002 (Cth) (and corresponding State legislation). Under this legislation, research involving human embryos can only be performed if authorized by the National Health and Medical Research Council (NHMRC) through a specific research license. Human Research Ethics Committee (HREC) approval is a prerequisite for every license application and each subsequent variation of the license. Each application is reviewed on the basis of compliance with the Acts, the Ethical Guidelines on the use of assisted reproductive Technology in Clinical Practice and Research and the National Statement on Ethical Conduct in Human Research. After a license is granted, regular inspections and reporting processes guarantee that license conditions are strictly adhered to. Genea Biocells holds NHMRC licenses #309703 and #309710.

In addition to Australian regulations, Genea Biocells stem cell lines are also compliant with the following international guidelines for human embryo and stem cell research:

National Academy of Sciences (NAS) Guidelines for Human Embryonic Stem Cell Research

National Institute of Health (NIH) Guidelines for Research using Human Stem Cells

UK Stem Cell Bank Steering Committee Code of Practice for Use of Human Stem Cell Lines

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