Islet Transplantation in Type 1 Diabetics Using the Edmonton Protocol of Steroid Free Immunosuppression
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00133809 |
Recruitment Status :
Completed
First Posted : August 24, 2005
Results First Posted : June 1, 2016
Last Update Posted : July 18, 2016
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 1 | Drug: Transplantation of Human Islets | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
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 |

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
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Drug: Transplantation of Human Islets
Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure |
- 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.
- 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
- 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.
- 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

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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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133809
United States, Georgia | |
The Emory Transplant Center | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Nicole A Turgeon, MD | Emory University | |
Principal Investigator: | Christian P. Larsen, MD DPhil | Emory University |
Publications of Results:
Responsible Party: | Nicole Turgeon MD, Associate Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT00133809 |
Other Study ID Numbers: |
IRB00041120 10402 ( Other Identifier: Other ) |
First Posted: | August 24, 2005 Key Record Dates |
Results First Posted: | June 1, 2016 |
Last Update Posted: | July 18, 2016 |
Last Verified: | June 2016 |
Type 1 Diabetes Islet Transplantation Immunology |
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |