Islet Transplantation in Type 1 Diabetics Using the Edmonton Protocol of Steroid Free Immunosuppression

Study Description

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Brief Summary:

This trial will study the ability of islet transplantation to restore glycemic control and achieve insulin independence in type 1 diabetic subjects with life-threatening hypoglycemia and unawareness, or recurrent hyperglycemia with ketoacidosis.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 1	Drug: Transplantation of Human Islets	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	8 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Islet Transplantation in Type 1 Diabetes Using the Edmonton Protocol of Steroid Free Immunosuppression
Study Start Date :	July 2002
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Islet Transplant; All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant	Drug: Transplantation of Human Islets; Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure

Outcome Measures

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Primary Outcome Measures :

1. The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation [ Time Frame: one year after transplant ]
   Independence from insulin injections is measured by the actual use of insulin by the study participants.

Secondary Outcome Measures :

1. Number of Insulin-independent Subjects Following Islet Transplantation [ Time Frame: 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation ]
   Participants who did not need to take insulin at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months following islet transplantation
2. Number of Subjects With HbA1C ≤ 6.5% [ Time Frame: 1, 3, 6, 9,12,18,24, 36, 48 and 60 months post-transplantation ]
   HbA1C was assessed in subjects 1, 3, 6, 9,12,18,24, 36, 48 and 60 months after transplantation and the number of subjects with values ≤ 6.5% was recorded which indicated better control of blood glucose levels.
3. The Number of Subjects Exhibiting Fasting C-peptide Levels ≥ 0.5 ng/mL [ Time Frame: 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation ]
   Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels at 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months after islet cell transplantation

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Type 1 diabetes mellitus diagnosed > 5 years previously
• Body mass index less than or equal to 26
• 18 to 65 years of age
• Compliance with an optimized diabetic management plan as assessed by an Emory University endocrinologist
• Checking and recording blood sugars at least 3 times per day
• Intensive insulin therapy (injecting insulin at least 3 times a day or using an insulin pump)
• Severe hypoglycemia and/or hyperglycemia. Severe hypoglycemia is defined by: episodes requiring assistance by others and/or hypoglycemic unawareness (the inability to recognize blood glucose < 54 mg/dL). Severe hyperglycemia is defined by: two episodes of ketoacidosis requiring hospitalization within the past year.

Exclusion Criteria:

• Renal dysfunction
• Severe co-existing cardiac disease, characterized by any one of these conditions: recent myocardial infarction (within past six months); angiographic evidence of non-correctable coronary artery disease; or evidence of ischemia on a dobutamine stress echocardiogram.
• Current bacterial or fungal infection
• Macroproteinuria
• Baseline hemoglobin < 11.4 gm/dL in women; < 12.9 gm/dL in men.
• Hyperlipidemia
• Positive tests for human immunodeficiency virus (HIV), or hepatitis B or C
• Negative antibody test for varicella zoster virus (subjects may be reconsidered if they receive the vaccination and convert to a positive antibody)
• History of malignancy (except squamous or basal cell skin carcinoma)
• Previous/concurrent organ transplantation
• Presence of HLA panel reactive antibodies > 20%
• Active peptic ulcer disease
• Evidence of gallbladder disease including cholecystitis and cholelithiasis
• Evidence of liver disease including hepatic neoplasm, portal hypertension, or persistently abnormal liver function tests.
• Persistent coagulopathy or current use of anticoagulants (not including aspirin)
• Sickle cell anemia
• Positive pregnancy test, intent for future pregnancy, failure to follow effective contraceptive measures, or presently breastfeeding
• Active alcohol or substance abuse. This includes smoking (must be abstinent for six months). Active alcohol abuse should be considered using the current National Institute on Alcohol Abuse and Alcoholism (NIAAA) definitions.
• Psychiatric disorder making the subject not a suitable candidate for transplantation
• Current use of systemic steroid medications
• Evidence of insulin resistance (insulin requirement > 1.2 units/kg/day)
• Inability to provide informed consent
• Any condition or any circumstance that makes it unsafe to undergo an islet transplant

Contacts and Locations

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Locations

United States, Georgia
The Emory Transplant Center
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Juvenile Diabetes Research Foundation

Investigators

Principal Investigator:	Nicole A Turgeon, MD	Emory University
Principal Investigator:	Christian P. Larsen, MD DPhil	Emory University

More Information

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Additional Information:

Juvenile Diabetes Research Foundation, non-profit organization, sponsor of this study 

Emory Transplant Center website 

Publications of Results:

Turgeon NA, Avila JG, Cano JA, Hutchinson JJ, Badell IR, Page AJ, Adams AB, Sears MH, Bowen PH, Kirk AD, Pearson TC, Larsen CP. Experience with a novel efalizumab-based immunosuppressive regimen to facilitate single donor islet cell transplantation. Am J Transplant. 2010 Sep;10(9):2082-91. doi: 10.1111/j.1600-6143.2010.03212.x.

Responsible Party:	Nicole Turgeon MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier:	NCT00133809 History of Changes
Other Study ID Numbers:	IRB00041120; 10402 ( Other Identifier: Other )
First Posted:	August 24, 2005
Results First Posted:	June 1, 2016
Last Update Posted:	July 18, 2016
Last Verified:	June 2016

Keywords provided by Nicole Turgeon MD, Emory University:

Type 1 Diabetes; Islet Transplantation; Immunology

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases	Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases