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Allogenic Islet Cell Transplantation

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: NCT00160732
Recruitment Status : Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The purpose of this study is to determine the safety of transplanting human islet cells for controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In addition, initial observations will be made with regards to the effectiveness of reversing hypoglycemia with this treatment. The "Edmonton Protocol" of using specific anti-rejection drugs without steroids is also being evaluated.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Allogenic islet cells (human, U. Chicago) Procedure: Intraportal infusion of islet cells Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogenic Islet Cells (Human, U. of Chicago) Administered Via Intraportal Infusion; and Immunosuppressive Therapy
Study Start Date : October 2003
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Transplant Drug: Allogenic islet cells (human, U. Chicago)
Human allogenic islet cells. Immunosuppression varies but may include prograf, celcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.

Procedure: Intraportal infusion of islet cells
Intraportal infusion of islet cell through the portal vein in the liver.




Primary Outcome Measures :
  1. decrease in insulin requirement - Subjects able to maintain fasting blood glucose concentrations below 126 mg/dL and 2-hour post prandial levels below 180 mg/dL will be considered to be insulin independent. [ Time Frame: Monthly ]
  2. decrease in incidence of hypoglycemic events [ Time Frame: Monthly ]

Secondary Outcome Measures :
  1. absence of complications from the procedure and side effects of the medication [ Time Frame: Monthly ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have type I diabetes mellitus, documented by undetectable C-peptide. Patients must have been diabetic for at least five years, and be aged 18 - 58 years.
  • Patients must be on an intensive regimen of glucose monitoring and exogenous insulin injection (defined as greater than or equal to three checks and injections per day). This regimen must be prescribed and supervised by the patient's diabetologist.
  • Despite intensive therapy, patients must have at least one of the following:

    • Brittle diabetes (metabolic instability), as defined by elevated mean amplitude of glycemic excursion;
    • Hypoglycemic unawareness, with at least one episode in the past two years in which hypoglycemia required the assistance of another person (e.g., family member, emergency medical technician [EMT], etc.), and was associated with a fingerstick blood glucose (FSBG) of < 50 mg/dl and prompt recovery after administration of oral glucose, intravenous glucose, or glucagon;
    • Progressive complications of diabetes (nephropathy manifested by proteinuria, retinopathy documented by an ophthalmologist after dilated eye exam, or neuropathy as determined by a neurologist).
  • Patients must be able to give informed consent.

Exclusion Criteria:

  • Failure to meet inclusion criteria
  • Panel of Reactive Antibody (PRA) > 10%
  • Creatinine clearance < 80 mL/min
  • Prior organ transplant
  • Portal hypertension: this refers to portal hypertension diagnosed previously by any means, or, by the investigators' evaluation, symptoms and/or signs of liver dysfunction with or without portal hypertension including, but not limited to, jaundice, ascites, encephalopathy, spider angiomata, coagulopathy, or peri-umbilical venous engorgement. Elevated portal pressures, as measured during intended islet infusion, may also result in discontinuation of infusion.
  • Abnormal liver function tests (> 2 times the upper limit of normal as defined by the University of Chicago Clinical Laboratory)
  • History of malignancy. Any history of malignancy in a patient who has had an "adequate" period of no evidence of neoplastic disease should not rule out individuals from enrolling in this study. Rather, pre-enrollment screening for malignancy will follow current established guidelines as for solid-organ transplant. These current guidelines appear in Kasiske, B.L., et al. "The Evaluation of Renal Transplant Candidates: Clinical Practice Guidelines," American Journal of Transplantation 1 (Supplement 2): 12-22, 2001.
  • Active peptic ulcer disease
  • Pregnancy, or inability to comply with contraceptive regimen
  • Severe unremitting gastroparesis or diarrhea
  • Active infection
  • Serologic positivity for HIV and/or hepatitis
  • Chest radiographic abnormality consistent with neoplastic or infectious disease
  • Major ongoing psychiatric illness and/or substance abuse
  • Noncompliance with current medical regimen
  • Obesity (body mass index [BMI] > 28)
  • Any other medical condition precluding safe transplantation and immunosuppression
  • Ejection fraction < 30%
  • Myocardial infarction (MI) within the past 6 months
  • Known allergies or hypersensitivity to immunosuppressive agents used in this protocol
  • Inability to provide written informed consent.

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): NCT00160732


Locations
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United States, Illinois
The University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Piotr Witkowski, MD, Ph.D. University of Chicago
Publications:
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00160732    
Other Study ID Numbers: 12176A
BB-IND 11228
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: September 2019
Keywords provided by University of Chicago:
Islet Cell Transplant
Human islet cell infusion
Juvenile-onset diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases