ISCBI Scoping plans
Workplan for the International Stem Cell Banking Initiative
The ISCF represents a unique forum for supporting activities in stem cell research that require integrated international collaboration. Forum members have agreed that stem cell banking is one such activity that would benefit significantly from coordination of international efforts, which should aim to promote:
- Minimum standards for cell line quality control
- Comparability of data produced in different centres around the world
- International exchange of cell lines and other research materials
Two phased meetings will be held under the initiative. These will gather together experts from stem cell research with additional input from experts in other relevant fields, including regulatory agencies. The first meeting is to focus on international standards for supplying stem cell lines and the second on issues for the clinical application of stem cells.
Meeting one: coordination of suppliers of stem cell lines for stem cell research
The first meeting will bring together laboratories which have established, or are aiming to establish, service culture collections of hES cells. It will draw on international expertise in appropriate regulatory issues and specialist technologies such as cryobiology, cell engineering and toxicology.
Meeting two: coordinating international standards on issues relating to the clinical application of stem cells
The outcomes of the first meeting will inform the establishment of a specialist group with experience in, or imminent intention to supply, stem cells for clinical applications. A meeting of this group will consider the critical issues for progressing stem cell lines, including research developments in culture, the differentiation of stem cells to deliver reliable and validated cell banks, and protocols for clinical trials. Expertise will be incorporated from those working with bone marrow and blood-derived stem cells and national and international regulatory bodies.
The meeting is likely to raise issues that would require a longer-term programme of development, and could be used to initiate a series of activities to help establish the ground rules for development of therapies based on stem cells and, particularly, stem cell lines. This meeting could be expected to include discussion on:
- Appropriate biomarkers for clinical grade cells.
- More complex microbiological issues for the use of stem cell lines.
- Appropriate models for the clinical validation of culture protocols and characterisation methods.
- Animal and in vitro assays and batch release tests for functional and clinical efficacy of stem cell products.
Issues to be addressed at the meetings
Generic issues that might be addressed include:
- Appropriate cell banking systems for stem cell lines.
- Optimisation of preservation and storage methods to ensure reproducible supplies of cells in the long term.
- Clean cell culture environments and a high degree of aseptic processing to avoid contamination and enable antibiotic-free cell culture.
- Robust regimes for quality control of stem cell lines, including virological testing.
- Careful maintenance, ongoing characterisation and development of seed stocks.
- Ethical governance of stem cell banks.
- International transfer of cells (coordinated with the existing ISCF projects).
- Databases and other data management systems for collections of stem cell lines.
Intended outputs from the meetings
An immediate output from the first meeting will be a consensus report on critical issues and fundamental principles for the maintenance of stem cell banks. Agreement will also be sought on the need for further outputs that require more time. These might include:
- An international code of best practice for stem cell banking.
- Evaluation of, and recommendations on, different quality control techniques.
- Advice on issues such as the international transfer of stem cell lines.
- Support establishing quality control procedures.
- Identification of sources of training and quality control service providers.
To disseminate the outcomes, which will be important to many stem cell researchers, the intention is to publish the initial meeting report and subsequent outputs in stem cell journals.
A report will also be produced and published from the second meeting on banking of clinical grade stem cells. Other outputs from this meeting might include:
- An international code of minimum best practice for developing cell lines for clinical use.
- Models of science-based risk assessment for stem cell cultures.
- Recommendations on quality control and safety testing of stem cell banks for clinical use.
- Models for validation of stem cell protocols for clinical application.
- A directory of national and international bodies responsible for regulation of stem cell therapy.
- Guidance for successful international transfer and use of clinical grade stem cells.
Conclusion
The ISCF banking initiative will aid the development of international efforts on harmonisation and best practice for preparation of high quality cells for research. It will also provide a key forum for rigorously evaluating some of the requirements for the clinical application of stem cell lines. The project should also stimulate further international initiatives to deliver safe and reliable stem cell therapies for the future.
