Berlin ISCT 2006
With the explosion of research, clinical trials and general interest in the basic science and therapeutic applications of all types of cell, gene and tissue-based technologies, the International Society for Cellular Therapy (ISCT) serves as a global forum and voice for clinicians, scientists, regulatory and laboratory personnel.

In May 2006, the 12th Annual Meeting of the ISCT will take place in Berlin, Germany. The Peter MacCallum Cancer Centre will present the results of their recent collaboration with Cryosite at this symposium.

 

Privatised “Rainy Day” Storage of Adult Peripheral Blood Stem Cells at an Offsite Location - a Paradigm that works.

A. Yallourdis¹, G. Douglas¹, P. Gambell¹, D. Wall¹, L. Mints-Kotowska¹, M. Maroulis², H. M. Prince^1,3;
¹Peter MacCallum Cancer Centre, Melbourne Victoria, AUSTRALIA, ²Australian Red Cross Blood Service, Melbourne Victoria, AUSTRALIA, ³University of Melbourne, Melbourne, AUSTRALIA.

Aim: Most hospitals have restricted capacity to store Peripheral Blood Stem Cells (PBSC). However, there are diseases where storage of PBSC for long-term future use is required. We decided to offer this service through a third-party off-site storage provider. A proviso was that cells would be collected and stored according to our existing existing GMP licence from the Australian Therapeutic Goods Administration (TGA) for collection, processing and storage.

Method: The paradigm was that patients would have collection and cryopreservation at the Centre for Blood Cell Therapies (CBCT) in Melbourne for storage at a GMP licenced storage contractor, Cryosite, in Sydney until required for autologous transplantation. We extended our GMP license to allow for off-site storage by using process change management which included: audit of the external site for GMP compliance; common Standard Operating Procedures (SOP) and forms for both sites; modified patient consents (with payment schedules), and validation with dry runs of the Cryoshipper. Our attempts to get insurer coverage of the storage costs was unsuccessful. Insurers re-imbursed patients for the mobilization and collection costs.

Results & Conclusion: TGA extended our license to allow PBSC storage at Cryosite in September 2005. Patient acceptance was excellent. We allowed for large CD34 content in the collections anticipating loss of cell viability over time. To date, 26 of 27 possible PBSC collections have been despatched for Cryosite storage. One consented patient was ineligible for storage due to reactive viral serology (as per GMP licence). The 26 patients constitute a total of 28 mobilisations, accounting for 13% of all mobilisations collected in the given time. 200 bags have been successfully transferred, averaging 8 bags per set of collections (SD=3). Disease indications have included follicular lymphoma in a state of minimal residual disease (MRD), chronic myeloid leukemia with MRD following imatinib therapy and smouldering myeloma.