Alert no longer in force
Issued 27 October 2006
This alert is being issued by the Human Tissue Authority (HTA) in its role as Competent Authority under the European Union Tissue and Cells Directive.
The HTA is working with the Irish Medicines Board and the Dutch Healthcare Inspectorate to trace stem cells distributed by Advanced Cell Therapeutics / Biomark / CellTech /BioCells. Allegedly, stem cells which were originally intended for research have been distributed and used for human application.
This alert is to ensure that:
All establishments storing on behalf of ACT / Biomark /CellTech / BioCells or storing material which originated from ACT / Biomark / CellTech / BioCells contact Kristi Collins, Regulation Manager on 020 7211 3413 immediately.
Establishments are aware of their obligations to ensure the traceability of tissues and cells, maintaining a robust audit trail.
During the week beginning 2 October 2006, the HTA learnt that a UK patient treated in a Dutch clinic was admitted to hospital with an adverse reaction to treatment using stem cells. It is alleged that the stem cells originated from ACT.
In addition to this, concerns are held by the Irish Medicines Board relating to the treatment of patients in Ireland, allegedly with stem cells originating from ACT.
Action taken by the HTA
The HTA has issued Special Directions to an establishment storing cells from BioCells/ACT to retain the material so it may be tested, if necessary, as part of any future investigation.
Actions for Tissue Banks
If you are:
- storing material on behalf of ACT / Biomark / CellTech / BioCells;
- storing material which originated from ACT / Biomark / CellTech / BioCells;
- are aware that any other tissue establishment is doing so;
you must inform the HTA immediately or seek advice as necessary.
2. BY 6 APRIL 2007
To meet the HTA standards you will need to implement a coding and records system which facilitates the traceability of bodies, body parts, tissues and cells. As a minimum you must ensure the following.
- There is a donor identification system which assigns a unique code to each donation and the products associated with it.
- All tissues and cells are traceable from donor to recipient and vice versa.
The end use of the tissue is clearly documented.
- A system is in place for keeping data which is necessary to ensure traceability at all stages for a minimum of thirty years after clinical use or expiry as the case may be.
Please contact the HTA on 020 7269 1900 or email email@example.com if you would like any further advice on any of the above points or you are storing tissue on behalf of ACT / Biomark / CellTech / BioCells.
Further guidance in relation to your obligations under the European Union Tissues and Cells Directive can be found by referring to the HTA Directions 001/2006.