First Encapsulated Islet Transplant without Long-term Immune Suppression into a Patient with Type 1 Diabetes

Main Category: Diabetes
Article Date: 18 Apr 2005 - 10:00 PDT


AmCyte Inc, a leader in encapsulated islet replacement and pancreatic adult stem cells, announced today the transplantation of the first Type 1 diabetic patient in North America to receive islets without long-term immune suppression.

The transplant took place on February 22nd at Toronto General Hospital. The patient experienced no complications during the minor 20-minute surgical infusion. The patient was released from hospital three days after the procedure and is resting at home. The transplanted islets are protected from rejection by the patient's immune system with AmCyte's novel microencapsulation technology. About the size of a pinhead, each clear gel bead contains multiple islets, and floats freely in the patient's abdominal cavity. The capsules are permeable so that nutrients and glucose can get to the islets, and secreted insulin from the islets can get out into the blood.

"At this point we are very happy that the patient is doing well," said Oliver Foellmer, AmCyte's Director of Business Development. "The clinical trial represents a new generation of islet transplantation technology and is part of a multi-prong clinical trial strategy to bring a treatment for diabetes to the market."

"We are excited to contribute this important step towards a treatment for diabetes without the health risks of immune suppression," said Dr. Wen G. Tsang, Sr. VP R&D. "In conjunction with our Adult Stem Cell Regenerated Islet Program, we look forward to being able to address both the limitations of immune suppression and islet supply."

Approved by Health Canada, the clinical study's primary endpoints are safety assessments of the procedure at 180 days with secondary endpoints looking at the function of the transplanted insulin producing islet cells. This study's conservative dose of islets may not be sufficient to fulfill the patient's insulin requirements. Future studies would address the issues of appropriate dosing of encapsulated islets.

The trial is being conducted at the Toronto General Hospital (TGH) of the University Health Network in collaboration with TGH's Multi Organ Transplant (MOT) Program (http://www.torontotransplant.org). The TGH Multi Organ Transplant Program is an international leader in transplantation and in enhancing the quality of life for its transplant patients. It is Canada's largest transplant program, performing approximately 300 transplants annually, and providing lifelong follow-up care to over 2,500 transplant recipients. Its unique integration of patient care, education and groundbreaking research makes it a model for many other transplant centers worldwide.

AmCyte Inc., located in Santa Monica, California, specializes in islet transplantation therapy. AmCyte has developed encapsulation technology to allow transplantation of insulin-producing islets without chronic immune suppression. The company is also developing human adult stem cell approaches in its Adult Stem Cell Regenerated Islet Program to address the limited supply of transplantable islets.

http://www.amcyte.com/news.htm

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