To be successful, the ICTU will need to confront the following issues that are a challenge to all islet cell transplant programs:
- Development of a human islet cell procurement program. The program must be designed so that optimal and rapid procurement of pancreas from donor can be accomplished to ensure that viability of islet cells is maintained.
- Improving islet cell harvesting and preservation to allow maximal flexibility in transplanting procedures.
- Maximizing the yield of islet cells from each pancreas so as to avoid the need for multiple transplants.
- Techniques of transplantation that allow for maximal survival of islet cells with a minimum of procedural side-effects.
- Anti-rejection protocols that prevent rejection of islet cells as foreign tissue and prevent autoimmune destruction of the transplanted cells. Protocols will utilize drugs that maximize islet cell function (avoidance of corticosteroids and islet cell toxins) and have minimal side effects on overall immunity.
- Post-operative metabolic management of transplant recipients.
To confront these challenges, the ICTU at Hadassah will be designed as a multi-disciplinary program encompassing diabetologists, transplant surgeons, immunologists, invasive radiologists, experts in islet cell culture and preparation, and support staff. The ICTU will develop the following programmatic aspects that will enable it to deal with the issues listed above.
- Development of a national islet cell recruitment program. The program will be designed to increase physicians' awareness of islet cell transplant, develop the means of transporting potential donors to HMO or performing surgical removal of pancreas at other institutions, and organ preservation during the initial harvesting phase. Participants in the program will also have the responsibility for identifying and preparing potential recipients.
- Islet cell preparation unit. The unit will have round-the-clock staff who will be prepared to isolate islet cells from the pancreas as soon as these are available. The Unit will also have the equipment to maintain and test islet cells and cell function.
- Transplant team. The team will consist of a surgeon, diabetologist, invasive radiologist, immunologists, and ICTU nurse. The responsibility of the team will be to prepare the recipient, perform the transplant, manage the diabetes during the initial operative phase, and provide care during the immediate post-operative phase.
- Post-transplantation care. ICTU staff including diabetologist, immunologist, and ICTU nurses will monitor and treat rejection episodes of the islet cells. The function of the islet cells will be frequently assessed, and if necessary, appropriate treatment for residual diabetes will be instituted.
An important feature of the ICTU will be the islet laboratory. This will be an ultra-modern, sterile facility with state of the art equipment for isolating and preparing human islet cells. Technicians in the facility will be responsible for isolating islet cells from fresh pancreas removed from donors post-mortem. To maintain maximal viability of cells, the procedure for isolation will require a large-scale apheresis system that facilitates rapid separation of islet cells from other cellular components. Exposure to low temperatures which damages islet cells will be minimized. In addition, all isolation procedures will be done using human blood products rather than animal to avoid the possibility of contamination. The facility will also have the necessary equipment for assaying the number of islet cells, for culturing cells, and for testing their functional capacity. Technicians at the facility will maintain an on-call schedule so that islet cell preparations can be done at any time.