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National Patient Safety Agency - National Research Ethics Service - facilitating and promoting ethical research
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Stem cell therapy

The Gene Therapy Advisory Committee (GTAC) is the national flagged Research Ethics Committee for review of  clinical trials of stem cell therapies derived from stem cell lines. Application for ethical review should be made to GTAC rather than another REC.
 
A stem cell line is defined as a permanently established culture of unspecialised cells derived from a single parental cell, or group of parental cells, that can (i) proliferate in vitro for a prolonged period when given appropriate nutrition and space and (ii) be made to differentiate in culture into more specialised types when given appropriate chemical or molecular cues.

Stem cell therapies

The remit of GTAC includes cell therapies derived from:
 
  • genetically modified cells;
  • embryonic stem cell lines;
  • multipotent stem cell lines;
  • mesenchymal stem cell lines;
  • foetal stem cell lines; and
  • induced pluripotent stem (iPS) cell lines.
Other types of research study involving well established adult stem cell therapies (for example, bone marrow transplantation) , but not involving stem cell therapies derived from stem cell lines, may be reviewed by any appropriate REC.

A UK Stem Cell Toolkit has been developed by UK regulators as a reference tool for those who wish to develop a programme of human stem cell research and manufacture, ultimately leading to clinical application.