Clinical Program

ICTU- The Clinical Program

ICTU has a number of ongoing clinical tests and research.
  1. Organ Procurement - The number of islet cells per pancreas is limited, and the goal is to maximize islets harvested per pancreas. This involves both optimal isolation techniques and maintaining islet viability. Criteria for selection of donor pancreas must be extremely stringent. These include age, body mass index, and duration of intensive care. Surgical techniques employed in harvesting the pancreas are critical since the time of warm and cold ischemia affects cell viability.
  2. Islet Isolation - Progress has been made on increasing the yield of viable islet cells harvested per gram of pancreatic tissue. Cells are continuously maintained in optimal conditions to avoid ischemic changes. Fresh cells are also used for transplantation to ensure maximal cell survival.
  3. Quantification and Functional Testing - A key to the success of a given transplant is the number of viable, functional cells transplanted. As part of the preparation of islet cells for transplant, isolated islet cells will be tested for viability and the ability to appropriately secrete insulin. The assays used will be designed for rapid turn around so that results will be available immediately after islet cell harvest.
  4. Transplantation - ICTU will focus on developing the least invasive methods for transplantation that ensure maximal survival of islet cells. The liver being the primary target for insulin action, the preferred approach will be a percutaneous trans-hepatic approach in which islet cells are injected into the portal vein under fluoroscopic guidance.
  5. Patient Pre-and-Post-Op Management - Pre-operative management will focus on preventing the transmission of infectious diseases (especially cytomegalovirus and other DNA viruses) via transplanted cells. Patients will be started on an immunosuppressive regimen that will be initiated pre-operatively and continued throughout the post-operative period.
  6. Long-Term Post Transplantation Management - Endocrinologists and diabetes specialists will follow patients in terms of their metabolic management. Patients will be periodically assessed to determine their insulin reserve and whether they are experiencing episodes of either hyper- or hypoglycemia. If necessary, exogenous insulin will be provided. The team will also decide whether an additional transplant procedure is necessary. The immunologists participating in the ICTU will manage the immunosuppressive regimen and monitor patients for acute and chronic rejection episodes. They will also determine whether the transplanted islet cells are undergoing autoimmune attack.
  7. Quality of life analysis - One of the main issues of islet cell transplantation is cost-benefit. The procedure is costly and patients must receive expensive and potentially toxic agents to prevent rejection. A cost benefit analysis, performed by specialist, will determine whether the tangible and intangible benefits associated with islet cell transplantation outweigh the costs.