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:
- Consensus on best practice standards for cell line banking including core activities such as governance and quality control
- Comparability of data produced in different centres around the world
- International exchange of cell lines and other research materials
A proposal to coordinate the activities of stem cell banks around the world was brought to the ISCF in 2007 and received funding from ISCF to run a series of meetings under the title of the International Stem Cell Banking Initiative (ISCBI).
Coordination of suppliers of stem cell lines
A series of meetings have been held since 2007 initially at the Jackson Laboratories in Bar Harbour, Maine and latterly in Beijing and the United Kingdom. These meetings have gathered together experts from stem cell research and stem cell banking with additional input from experts in other relevant fields, including regulatory agencies. The first meeting focused on international standards for supplying human embryonic stem cell lines for research applications and more recent meetings have focused on the additional requirements for establishing banks of clinical grade stem cell lines.
Consensus on best practice for banking, testing and distribution nof human embryonic stem cell lines for research purpose
The first published output from the ISCBI group was a consensus document on principles of best practice for centres supplying human embryonic stem cell lines for research purposes. This document, published in Stem Cell Reviews and Reports provided guidance on how a stem cell bank should operate from the point of obtaining deposits of new cell lines through to the process of shipping samples of cell lines to researchers. It is important to note that the principles given in this guidance are also directly relevant as best practice for any researcher obtaining and using stem cell lines including induced pluripotent stem cells. The full reference for the guidance is:
Andrews, P.W., Arias-Diaz, J., Auerbach, J., Alvarez, M., Ahrlund-Richter, L., Baker, D., Benvenisty, N., Ben-Josef, D., Blin, G., Borghese, L., Borstlap, J., Bruce, K., Brüstle, O., Buckle, R., Camby, C., Choo, A.B., Chen, W., Collins, D., Colman, A., Crombie, C., Crook, J.M., Cypess, R., De Sousa, P., Dhawan, J., Douay, L., Dvorak, P., Dyke, T., Eriksson, L., Firpo, M., Fitzgerald, C., Glover, C., Gokhale, P., Greene, M., Ha, H-Y., Hampl, A., Healy, L., Hei, D., Holm, F., Hovatta, O., Hunt, C., Hwang, S-M., Inamdar, M., Isasi, R., Itskovitz-Eldor, J., Jessie, N., Kim, D-W, Kirzner, R., Kiatpongsan, S., Knowles, B.B., Kuo, H-C., Laughlin, M., Lavon, N., Ludwig, T., Lakov, M., Lee, D-R., Macauley, J., McKay, R., Menasche, P., Menendez, P-M., Michalska, A., Mileikovskaia, M., Minger, S., Mishra, G., Moody, J., Montgomery, K., Morris, C., Mummery, C., Nagy, A., Nakamura, Y., Nakatsuji, N., Nishikawa, S-I, Oh, S., Oh, S-K, Olson, P., Otonkoski, T., M., Patole, M., Park, H-S., Pei, X., Pera, M., Rajala, K., Reubinoff, B., Robins, A., Rooke, H., Rumayor, V., Scotmann, H., Sherlock, J., Simon, C., Sipp, D., Skinner, R., Smith, D., Stacey, G.N., Stefanovic, S., Strehl, R., Taft, R, Takahashi, T., Talib, S., Terstegge, S., Turner, R., Tuuri, T., Yu, J., Zandstra, P., Zapata, A., Zeng, F., Zhou Q.,, Tannenbaum, S. (2009). Consensus guidance for banking and supply of human embryonic stem cell lines for research purposes. Stem Cell Reviews and Reports 5, pp301-314.
Coordinating International Standards on Issues Relating to 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. Subsequent meetings of this group considered 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 for clinical trials. Expertise has been incorporated from those working with bone marrow and blood-derived stem cells and national and international regulatory bodies and stem cell societies such as the International Society for Stem Cell Research and the International Society for Cell Therapy.
The meetings have raised 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. These meetings have included discussion on:
- Procurement of cell lines
- 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
As an extension of this work there has been a parallel consideration of the requirements for use of stem cell lines for the manufacture of biological products other than cell therapies (LINK to activities) such as vaccines. The output from the ISCBI subgroup on use of stem cell lines for manufacture of biological will be included in the ISCBI guidance on clinical grade stem cell banks.
Intended outputs from the meetings
An immediate output from the first meetings was intended to be a consensus report on critical issues and fundamental principles for the maintenance of stem cell banks (LINK). This was developed as an international code of best practice for stem cell banking (Andrews et. al., (2009) see above) as described on the ISCBI Activities page.
A report is also in preparation from the second series of meetings on banking of clinical grade stem cell lines (see ISCBI Activities).
The ISCBI has also supported occasional workshops (LINK) and most recently held a workshop at the National Institute for Biological Standards and Control to consider the needs for banking iPSC lines (LINK).
The ISCF banking initiative aids the development of international efforts on harmonisation and best practice for preparation of high quality cells for research. It has also provided a key forum for rigorously evaluating some of the requirements for the clinical application of stem cell lines and the challenges of banking induced pluripotency stem cell lines. The project partners will continue to stimulate further international initiatives to help deliver safe and reliable stem cell therapies for the future.