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Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen

2015-03-23 05:00:42 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and effectiveness of islet cell transplantation alone (ITA) in patients with difficult to control type I diabetes. Difficult to control type 1 diabetes is defined as wide swings in blood glucose that disrupt the patient's life and result in frequent episodes of low blood glucose despite the proper use of standard insulin therapy and frequent blood glucose monitoring.

Description

Type 1 diabetes is associated with the damage of a specific cell subtype of pancreatic islets (clusters of cells in the pancreas that produce insulin and other metabolic hormones), which makes patients depend on an outside source of insulin. Despite insulin treatment, type 1 diabetes mellitus causes a significant risk of long-term problems, including damage to the heart, blood vessels, nerves, eyes and kidneys. The results of recent research studies suggest that these complications are caused by poor glucose control.

Transplantation of islets offers the prospect of good glycemic (blood glucose) control without the major surgical risks associated with whole pancreas transplant and may result in not needing any insulin injections. In 2000, a group of investigators in Edmonton, Canada showed that islet transplantation using a combination of anti-rejection drugs to help prevent the rejection of transplanted islets was effective in eliminating insulin intake in 7 subjects who were followed up to 20 months. After 5 years, more than 60 patients have been transplanted at Edmonton and only 1 in 10 remained off of insulin.

This study is being performed to confirm the results of the Edmonton study to see if islet transplantation alone (ITA) is a safe and effective way of treating subjects with type 1 diabetes. This study uses a few additional medications and vitamin supplements that were not included in the original Edmonton study. We hope this will improve the long-term outcome of islet transplantation.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes Mellitus

Intervention

Islet Transplantation + Immunosuppression, Islet cell transplantation

Location

City of Hope Medical Center
Duarte
California
United States
91010

Status

Active, not recruiting

Source

City of Hope Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-03-23T05:00:42-0400

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PubMed Articles [20714 Associated PubMed Articles listed on BioPortfolio]

Assessing Islet Transplantation Outcome in Mice.

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Bilirubin improves the quality and function of hypothermic preserved islets by its antioxidative and anti-inflammatory effect.

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Medical and Biotech [MESH] Definitions

Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

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A primary malignant neoplasm of the pancreatic ISLET CELLS. Usually it involves the non-INSULIN-producing cell types, the PANCREATIC ALPHA CELLS and the pancreatic delta cells (SOMATOSTATIN-SECRETING CELLS) in GLUCAGONOMA and SOMATOSTATINOMA, respectively.

Preparative treatment of transplant recipient with various conditioning regimens including radiation, immune sera, chemotherapy, and/or immunosuppressive agents, prior to transplantation. Transplantation conditioning is very common before bone marrow transplantation.

A zinc efflux transporter highly expressed by ISLET CELLS of the pancreas. It functions in the accumulation of zinc in intracellular vesicles and may be involved in INSULIN maturation and storage processes. Variations in the SLC30A8 gene are associated with susceptibility to DIABETES MELLITUS, TYPE 2.

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