PANCREATIC ISLETS ALLOTRANSPLANTATION
BRITTLE TYPE 1 DIABETES MELLITUS
Pancreatic islet allotransplantation has been developed as a minimal invasive therapy and alternative to a whole pancreas transplantation.
Pancreatic islets are isolated by Dr. Witkowski’s team from a cadaveric pancreas at The University of Chicago cGMP facility, a special lab designed for processing cells for clinical therapy which is specially deisgned to process cells for the transplant.
Islets are cultured in an incubator and once the patient is ready, infused via the portal vein into the patient’s liver under local anesthesia. This procedure takes up to one hour. After the procedure, the transplanted islets help diabetic patients restore proper glucose control, prevent life-threating severe hypoglycemic episodes and ultimately remove the need for insulin supplementation.
Phase 1/2 and 3 studies have been successfully accomplished at The University of Chicago,. Biological License Application for islet cell as a biological product is in process for submission to the FDA. Approval from FDA, would allow islet transplantation to be a standard of care procedure that is reimbursed by medical insurance benefiting thousands of diabetic patients.
Currently, Dr. Witkowski is seeking additional research funding to continue optimization and efficiency of the procedure: protect patients from diabetes for longer periods of time, limit the need for immunosuppressive medication, limit side effects and reduce the necessary number of islets and number of transplants.
Pancreas is removed surgically from a deceased donor during a multi-organ surgical procurement and transported to the laboratory (cGMP facility).
Islets are then isolated, cultured and infused through the catheter introduced into the portal vein under local anesthesia by a interventional radiologist.
Pancreas and Islet Processing
Pancreas and islet processing take place in a special facility on-site at the University of Chicago Hospital. This laboratory meets all FDA requirements for cell and tissue processing for clinical applications and follows current Good Manufacture Practice rules and regulations.
Standardized islet processing carried out in the controlled environment of the cGMP facility, allows to reassure the highest quality of the final islet product.
Pancreas processing includes enzymatic digestion, islet separation, purification and culture. Prior to the islet infusion into the patient, islets are counted with a confirmation of quality and sterility.
Islet Transplantation as Minimally Invasive Procedure
An interventional radiologist accesses the portal vein with a small catheter through the skin under the guidance of ultrasound and fluoroscopy under local anesthesia.
Islets are suspended in a special solution and infused into the portal vein and settle down in the liver.
*Alternatively, the portal vein may be accessed via a mini-laparotomy under general anesthesia by the surgeon in the operating room.
First islet transplant at Columbia University Medical Center in the New York City, 2004.
Besides interventional radiologists, Dr. Mark Hardy supervises the procedure, Dr. Witkowski is "massaging" the islets during the infusion. Besides the interventional radiologists, Dr. Mark Hardy supervised the procedure, while Dr. Witkowski "massaged" the islets during the infusion.
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