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

NCT00133809 | Completed Phase 2 Results DMC

• 2 other identifiers: IRB0004112010402
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes; Islet Transplantation; Immunology

Outcome Measures

Primary Outcomes (1)

• The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation

  Independence from insulin injections is measured by the actual use of insulin by the study participants.

  one year after transplant

Secondary Outcomes (3)

• Number of Insulin-independent Subjects Following Islet Transplantation

  1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation

• Number of Subjects With HbA1C ≤ 6.5%

  1, 3, 6, 9,12,18,24, 36, 48 and 60 months post-transplantation

• The Number of Subjects Exhibiting Fasting C-peptide Levels ≥ 0.5 ng/mL

  1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation

Study Arms (1)

Islet Transplant

EXPERIMENTAL

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

Interventions

Transplantation of Human Islets DRUG

Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure

Islet Transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes mellitus diagnosed \> 5 years previously
• Body mass index less than or equal to 26
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

The Emory Transplant Center

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 20883542 RESULT

Related Links

• Juvenile Diabetes Research Foundation, non-profit organization, sponsor of this study
• Emory Transplant Center website

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Nicole Turgeon MD
• Organization: Emory University

nturgeo@emory.edu

404-727-3257

Study Officials

• Nicole A Turgeon, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Christian P. Larsen, MD DPhil

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 24, 2005
• Study Start: July 1, 2002
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 18, 2016
• Results First Posted: June 1, 2016

Record last verified: 2016-06

Locations

US (1)