Recruiting donors for stem cell research -National collaboration of hESC coordinators
Lead Research Organisation:
King's College London
Department Name: Midwifery and Women's Health
Abstract
Human embryonic stem cells can be isolated from very early (6 days) developing embryos which have been grown in the laboratory as part of, or surplus to certain kinds of IVF treatment. Under certain conditions, these cells can be made to develop into different types of tissues, such as nerve or pancreas which it is hoped in the future, may be useful in treating degenerative diseases such as Parkinson s disease and diabetes, or in spinal injuries by replacing the diseased or damaged cells with healthy cells which have been grown in the laboratory. The number of embryonic stem cell lines that have been developed worldwide is still quite limited and further research is required to find out the best means to grow them in ways which will allow them to be safe for clinical use. In order to facilitate these developments, a National Stem Cell Bank has been established in the UK where stem cell lines can be deposited and stored, tested for safety, and then made available for research and clinical use. All stem cell derivation from embryos is strictly monitored in the UK and requires a licence from the Human Fertilisation and Embryology Authority. It is also a condition of licence that a sample of any suitable stem cell lines developed must sent to the UK Stem Cell Bank from where they are made available to research scientists in the UK and abroad
Deriving these embryonic stem cells ethically is critically dependent on identifying those patients who are prepared to donate to research any suitable embryos that are no longer needed for their IVF assisted conception treatment. In 2003 the MRC made funds available for the appointment of Nurse Coordinators, not involved directly in the stem cell derivation, who could counsel and advise patients that may be prepared to donate surplus embryos to stem cell programmes. They have been very successful and a number of lines have been submitted to the stem cell bank from this source. They have also established a UK network of stem cell coordinators (hESCCO) which facilitates their collaborative working and through which they have developed a national consent form for patients wishing to donate to stem cell research. The bid to the MRC is to continue funding of the nurse coordinators and their network.
Deriving these embryonic stem cells ethically is critically dependent on identifying those patients who are prepared to donate to research any suitable embryos that are no longer needed for their IVF assisted conception treatment. In 2003 the MRC made funds available for the appointment of Nurse Coordinators, not involved directly in the stem cell derivation, who could counsel and advise patients that may be prepared to donate surplus embryos to stem cell programmes. They have been very successful and a number of lines have been submitted to the stem cell bank from this source. They have also established a UK network of stem cell coordinators (hESCCO) which facilitates their collaborative working and through which they have developed a national consent form for patients wishing to donate to stem cell research. The bid to the MRC is to continue funding of the nurse coordinators and their network.
Technical Summary
The UK has been able to establish a pre-eminent position in stem cell derivation and research due the presence of highly regulated but permissive legislation, strong support from government, and strategic support for the funding councils. The remit of the UK Stem Cell Bank, is to provide quality assured banks of stem cell lines suitable for use in clinical trials according to the demands of the Human Tissues and Cells Directive and applicable medicines regulation.
Ethical derivation of human embryonic stem cells is critically dependent on the availability of donated embryos obtained with transparent informed consent. Key to success is identifying patients prepared to donate embryos that are no longer needed for their assisted conception treatment using IVF, or from PGD centres that can generate lines containing specific clinically-relevant genetic defects.
As a result of the MRC strategic call in 2003 to facilitate and support interactions between IVF clinicians and research teams, some centres appointed nurses to facilitate the recruitment of patients who would be prepared to donate to stem cell research, fresh or frozen embryos surplus to their treatment. Through their efforts a number of fully characterised stem cell lines have been submitted to the bank. Although not yet under GMP conditions suitable for clinical use, they are available internationally for research purposes through the MRC Stem Cell Steering Committee.
Since the 2003 call, HFEA licence conditions now require a demonstrable separation between clinical and research decisions and information giving; hence the need for specific staff to fulfil this requirement if patient recruitment for stem cell generation is to continue.
One unique and positive outcome of the call has been the establishment of the UK Human Embryo Stem Cell Coordinators Network (hESCCO). With the support of the MRC, the coordinators have met biannually for a one-day meeting, which includes representatives of the MRC, HFEA and the UK stem cell bank. This collaborative working has enabled the development of a nationally agreed consent form for donation to stem cell generation, discussions over patient testing requirements with the regulators, sharing of information, recording of recruitment of patients to the various projects, and where appropriate, sharing of patients from different parts of the country who wish to donate.
The aim of this application is to seek refunding of these coordinators to continue the facilitation of donors to stem cell derivation programmes, and to fund the biannual hESCCO meetings.
Ethical derivation of human embryonic stem cells is critically dependent on the availability of donated embryos obtained with transparent informed consent. Key to success is identifying patients prepared to donate embryos that are no longer needed for their assisted conception treatment using IVF, or from PGD centres that can generate lines containing specific clinically-relevant genetic defects.
As a result of the MRC strategic call in 2003 to facilitate and support interactions between IVF clinicians and research teams, some centres appointed nurses to facilitate the recruitment of patients who would be prepared to donate to stem cell research, fresh or frozen embryos surplus to their treatment. Through their efforts a number of fully characterised stem cell lines have been submitted to the bank. Although not yet under GMP conditions suitable for clinical use, they are available internationally for research purposes through the MRC Stem Cell Steering Committee.
Since the 2003 call, HFEA licence conditions now require a demonstrable separation between clinical and research decisions and information giving; hence the need for specific staff to fulfil this requirement if patient recruitment for stem cell generation is to continue.
One unique and positive outcome of the call has been the establishment of the UK Human Embryo Stem Cell Coordinators Network (hESCCO). With the support of the MRC, the coordinators have met biannually for a one-day meeting, which includes representatives of the MRC, HFEA and the UK stem cell bank. This collaborative working has enabled the development of a nationally agreed consent form for donation to stem cell generation, discussions over patient testing requirements with the regulators, sharing of information, recording of recruitment of patients to the various projects, and where appropriate, sharing of patients from different parts of the country who wish to donate.
The aim of this application is to seek refunding of these coordinators to continue the facilitation of donors to stem cell derivation programmes, and to fund the biannual hESCCO meetings.