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A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01897688
Recruitment Status : Recruiting
First Posted : July 12, 2013
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Severe Hypoglycemic Unawareness Biological: Islet Cell Transplant Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
Study Start Date : June 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Islet Cell Transplant
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
Biological: Islet Cell Transplant


Outcome Measures

Primary Outcome Measures :
  1. To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes. [ Time Frame: 365 days after final islet infusion ]
    To assess the efficacy of islet cell transplantation under alemtuzumab induction immunosuppression on the proportion of subjects with a change in HbA1c and free of severe hypoglycemic events through Day 365 after the final islet transplant.


Secondary Outcome Measures :
  1. To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics. [ Time Frame: 365 days after final islet infusion ]
    To assess the proportion of insulin-independent subjects at Day 365 after the final islet transplant. TO compare islet graft outcome between alemtuzumab induction and historical antithymocyte induction groups. To relate clinical transplant outcomes based upon islet quantity/quantity to organ donor characteristics.


Eligibility Criteria

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

Inclusion Criteria:

  1. Male and female patients age 18-65 years of age
  2. Ability to provide written informed consent
  3. Mentally stable and able to comply with the procedures of the study protocol
  4. Patients with T1D and insulin-dependent for at least 5 years
  5. Absent stimulated c-peptide (<0.3 ng/mL) in response to a mixed meal tolerance test (MMTT; ensure 6 mL/kg body weight to a maximum of 360mL) measured at 60 and 90 min after the start of consumption
  6. Patients who have been followed by a qualified physician for diabetes management for a minimum of 12 months
  7. At least one episode of severe hypoglycemia in the past 12 months
  8. A Clarke score of 4 or more defining reduced awareness of hypoglycemia

Exclusion Criteria:

  1. Body mass index (BMI) > 30
  2. Insulin requirement of > 1.0 IU/kg/day
  3. HbA1c > 10%
  4. Calculated glomerular filtration rate (GFR) < 80 milliliter/minute (using subjects serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI)
  5. Macroalbuminuria >300 mg/g creatinine
  6. Panel reactive anti-Human Leukocyte Antigen antibodies> 50% by flow cytometry
  7. For female subjects: positive pregnancy test, breast feeding or unwillingness to use effective contraceptive measures for the duration of the study.
  8. Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB)
  9. Negative Epstein-Barr Virus (EBV) by (IgG) Immunoglobulin G
  10. Any history of malignancy except resected squamous or basal cell carcinoma
  11. Alcohol or substance abuse
  12. Baseline Hb below the lower limit of normal
  13. International normalized ratio >1.5 and long term anticoagulant therapy
  14. Clinically significant coronary artery disease
  15. Elevated liver function tests >1.5 times upper limit of normal
  16. Symptomatic cholecystolithiasis
  17. Gastrointestinal disorders interfering with ability to absorb oral medications
  18. Uncontrolled hyperlipidemia (LDL cholesterol >130 mg/dL and/or triglycerides >200 mg/dL)
  19. Chronic corticosteroid use
Contacts and Locations

Information from the National Library of Medicine

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): NCT01897688


Contacts
Contact: Xunrong Luo, MD, PhD (312) 908-8147 xunrongluo@northwestern.edu
Contact: Ojoma Agbo, MSc (312) 694-0253 ojoma.agbo@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Xunrong Luo, MD, PhD    312-908-8147    xunrongluo@northwestern.edu   
Contact: Ojoma Agbo, MSc    (312) 694-0253    ojoma.agbo@northwestern.edu   
Principal Investigator: Xunrong Luo, MD, PhD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Xunrong Luo, MD, PhD Northwestern University
More Information

Responsible Party: Xunrong Luo, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01897688     History of Changes
Other Study ID Numbers: STU00059469
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016

Keywords provided by Xunrong Luo, Northwestern University:
Diabetes
Islet
Pancreas
Hypoglycemia
T1D
Transplant

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Unconsciousness
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms