NEW YORK, April 27, 2010 (JDRF Press Release) \u2013 The Juvenile Diabetes Research Foundation announced today that it is partnering with Living Cell Technologies (LCT), a New Zealand-based biotechnology company focused on developing cell based therapeutics, in a Phase II clinical trial to study the safety and effectiveness of transplanting encapsulated insulin-producing cells from pigs as a treatment for type 1 diabetes with significant hypoglycemia unawareness.<\/p>\n
Through its Industry Discovery and Development Partnership program, JDRF will support the second part of a Phase II trial in New Zealand of LCT\u2019s DIABECELL\u00ae product; the trial will test the effectiveness of the transplant product when given in higher amounts in people with established and unstable type 1 diabetes who suffer from frequent hypoglycemia and hypoglycemia unawareness \u2013 an inability to sense when blood sugar is trending dangerously low.<\/p>\n
The DIABECELL\u00ae product comprises encapsulated, insulin-producing pancreatic islets derived from specially bred pigs.\u00a0 They are implanted into the abdomens of people with diabetes through a laparoscopic procedure, and work by sensing blood glucose and secreting insulin in response to high blood glucose levels.\u00a0 The encapsulation technology developed by LCT in DIABECELL\u00ae does not require immunosuppressant drugs to suppress the rejection of the islets by the immune system.<\/p>\n
In addition to assessing the safety of the treatment, the trial will also study whether the transplanted islets improve blood glucose control, reduce hypoglycemic episodes, reduce daily insulin requirements, and improve the quality of life of participants in the trial.<\/p>\n
According to Professor Bob Elliott, Medical Director of LCT, early results from the clinical trial, which began in October 2009, showed that the cell implants eliminated hypoglycemia unawareness in one of the trial participants — a complication that occurs in as many as 2 in 10 people with long-term type 1 diabetes, and can be fatal.<\/p>\n
Type 1 diabetes is an autoimmune disease in which a person\u2019s pancreas stops producing insulin, a hormone that enables people to get energy from food.\u00a0 Type 1 diabetes strikes children and adults suddenly, and lasts a lifetime. People with type 1 diabetes must take multiple injections of insulin daily or continuous infusion of insulin through a pump to survive.\u00a0 Intensive insulin treatment to normalize blood glucose levels and prevent future eye, kidney, nervous system and cardiovascular complications can sometimes result in hypoglycemic unawareness, a loss of the normal stress response to low blood glucose levels.\u00a0 People with type 1 diabetes and suffer from hypoglycemic unawareness feel no warning symptoms when their blood glucose levels drop to low levels that can impair consciousness and can lead to accidents and coma.<\/p>\n
Islet Transplantation Research <\/span><\/p>\n The insulin-producing islets used in the study come from pigs grown and harvested in optimal conditions whose health status was closely controlled and monitored, reducing the risk of safety threats.\u00a0 As pig insulin has been known to work in man, pigs are considered ideal candidates to provide islets for xenotransplantation (the transplantation of insulin-producing islets from non-human species into people with type 1 diabetes), the type of procedure described in the trial.<\/p>\n Pancreatic islet transplantation, a major research focus within JDRF\u2019s Beta Cell Therapies program, has the potential to normalize blood glucose levels by restoring insulin production for patients with type 1 diabetes.\u00a0 But because of a limited supply of human donors for pancreatic islets, scientists have investigated other possible sources of insulin-producing cells, which include the transplantation of insulin-producing islets from animals into people with type 1 diabetes (xenotransplantation).\u00a0 In addition, encapsulating islets has the potential to protect the transplant from immune rejection and eliminate the need for chronic immunosuppressive drugs in islet transplantation. \u00a0\u00a0Xenotransplantation and islet encapsulation are important areas of research interest to JDRF, funding approximately $3 million in xenotransplantation, and $3.5 million in islet encapsulation last year.<\/p>\n \u201cThe initial results from the first phase of the trial showed us a significant feature of LCT\u2019s product in its ability to protect the transplanted cells from immune rejection without the use of immunosuppressive anti-rejection drugs,\u201d said Julia Greenstein, Ph.D., Director of Beta Cell Therapies at JDRF.\u00a0 \u201cEncapsulation for immuno-protection is one of JDRF\u2019s research priorities, and the success of this trial could have an important impact on this field of research and the development of a commercially-viable cell replacement therapy for people with type 1 diabetes.\u201d<\/p>\n \u201cWe are delighted that the JDRF is supporting the progress we are making to advance DIABECELL\u00ae<\/sup> towards normalizing the lives of people with type 1 diabetes,\u201d said Dr. Paul Tan, Chief Executive Officer for LCT.<\/p>\n The collaboration with JDRF and LCT Technologies for the Phase II trial is part of JDRF\u2019s innovative Industry and Discovery and Development Partnership program. Through the program, JDRF partners with pharmaceutical, biotech, and medical device businesses that seek to develop drugs, treatments, technologies, and other therapeutics leading to a cure, reversal, or prevention of type 1 diabetes and its complications.\u00a0 To date, JDRF has 27 industry partners across a range of research areas since the IDDP program was established in 2004.<\/p>\n About JDRF<\/strong><\/p>\n JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder and advocate of type 1 research. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is a disease which strikes children and adults suddenly and requires multiple injections of insulin daily or a continuous infusion of insulin through a pump. Insulin, however, is not a cure for diabetes, nor does it prevent its eventual and devastating complications which may include kidney failure, blindness, heart disease, stroke, and amputation.<\/p>\n Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.4 billion to diabetes research, including more than $100 million in FY2009.<\/p>\n","protected":false},"excerpt":{"rendered":" The Juvenile Diabetes Research Foundation announced today that it is partnering with Living Cell Technologies (LCT), a New Zealand-based biotechnology company focused on developing cell based therapeutics, in a Phase II clinical trial to study the safety and effectiveness of transplanting encapsulated insulin-producing cells from pigs as a treatment for type 1 diabetes with significant hypoglycemia unawareness….<\/p>\n","protected":false},"author":131,"featured_media":29438,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1445],"tags":[246],"yoast_head":"\n