House of Lords written question – answered on 31st March 2011.
To ask Her Majesty's Government, further to the Written Answers by Lord Young of Norwood Green on 7 April 2010 (WA 433), whether the derivation of embryonic stem cell lines from human blastocysts created using nuclear transfers or variants thereof, publication of such work in a recognised scientific journal and deposition of the resultant stem cells with the UK Stem Cell Bank are all necessary prerequisites before any recommendation of clinical applications might or considered; and, if not, why not.
Any embryonic stem cell line which is intended for human therapeutic use will need to fulfil certain quality and safety requirements before administration to humans. The extent of the assessment will depend on the purpose of such administration, ie clinical research, application under hospital exemption or full marketing authorisation.
Researchers wanting to obtain embryonic stem cell lines from human blastocysts created by means of cell nuclear transfer or other means must apply for a licence from the Human Fertilisation and Embryology Authority (HFEA). It is a condition of a HFEA licence that a sample of the stem cell lines derived must be deposited in the UK Stem Cell Bank. To deposit a human stem cell line in the bank, applicants must provide copies of any published scientific papers related to the derivation and/or characterisation of the stem cell line.
Stem cells that are intended for human application come under the regulation of the Human Tissue Authority (HTA). Researchers would need to obtain a licence from the HTA for the processing and storage (and distribution and import/export if these activities are undertaken) of tissues and cells for human application. The HTA does not require researchers to publish their work in a scientific journal.
The Medicines for Human Use (Clinical Trials) Regulations 2004 regulate clinical trials of stem cells that are medicinal products. Where products are intended to be developed for a full licence (marketing authorisation), they specify how research on the safety and efficacy of medicinal product in human participants should be conducted and criteria for ethics review. No clinical trial can begin without the approval of both the Medicines and Healthcare products Regulatory Agency and the Gene Therapy Advisory Committee (GTAC). GTAC has United Kingdom-wide responsibility for the ethical oversight of clinical trials involving either gene therapy or cell therapies derived from stem cell lines.
For products intended to be used therapeutically on a non-routine basis, ie under hospital exemption as per Article 28 of the Advanced Therapy Medicinal Products Regulations (1394/2007), these will normally be evaluated on a case-by-case basis to ensure they fulfil the basic requirements of quality and safety.
More detailed information on the regulatory requirements of a stem cell clinical trial application is available at: www.sc-toolkit.ac.uk/home.cfm.
Yes1 person thinks so
No0 people think not
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