Study Stopped
Lack of efficacy
B-Lymphocyte Immunotherapy in Islet Transplantation
1 other identifier
interventional
2
1 country
1
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 the immunosuppressive medications and medications to support islet survival for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 1, 2007
CompletedFirst Posted
Study publicly available on registry
May 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMarch 21, 2016
February 1, 2016
4.8 years
May 1, 2007
February 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin independence
75 days after a single islet transplant
Secondary Outcomes (1)
reduction in insulin requirements, HbA1c, MAGE, LI, HYPO score, fasting glucose, beta score, quality of life
75 days and 1 year following first and final infusion
Study Arms (1)
Allogeneic Pancreatic Islet Cells
EXPERIMENTALParticipants will receive up to three islet transplants and maintenance immunosuppressive therapy.
Interventions
transplant of islet cells injected into the portal vein of the liver
Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.
Will replace antithymocyte globulin in all islet transplantations after the first one
Depletes transient B-cells
Maintenance immunosuppressive therapy
Eligibility Criteria
You may qualify if:
- Mentally stable and able to comply with study procedures
- Clinical history compatible with type 1 diabetes with onset at less than 40 years of age, insulin dependence for at least 5 years at study entry, and a sum of age and insulin dependent diabetes duration of at least 28
- Absent stimulated C-peptide (less than 0.3 ng/ml) 60 and 90 minutes post-mixed-meal tolerance test
- Involvement of intensive diabetes management, defined as:
- Self-monitoring of glucose values no less than a mean of three times each day averaged over each week
- Administration of three or more insulin injections each day or insulin pump therapy
- Under the direction of an endocrinologist, diabetologist, or diabetes specialist with at least three evaluations the 12 months prior to study enrollment
- At least one episode of severe hypoglycemia in the past 12 months, defined as an event with one of the following symptoms: memory loss; confusion; uncontrollable behavior; irrational behavior; unusual difficulty in awakening; suspected seizure; seizure; loss of consciousness; or visual symptoms in which the participant was unable to treat him/herself and which was associated with either a blood glucose (BG) level \< 54 mg/dL \[3.0 mmol/L\] or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, in the past 12 months prior to study enrollment
- Reduced awareness of hypoglycemia. More information about this criterion, including specific definition of hypoglycemia unawareness, is in the protocol.
You may not qualify if:
- Body mass index (BMI) greater than 30 kg/m2 or weight less than or equal to 50 kg
- Insulin requirement of more than 1.0 IU/kg/day or less than 15 U/day
- HbA1c greater than 10%
- Untreated proliferative diabetic retinopathy
- Systolic blood pressure higher than 160 mmHg or diastolic blood pressure higher than 100 mmHg
- Measured glomerular filtration rate using iohexol of less than 80 ml/min/1.73m2. More information about this criterion is in the protocol.
- Presence or history of macroalbuminuria (greater than 300 mg/g creatinine)
- Presence or history of panel-reactive anti-HLA antibody levels greater than 20% by flow cytometry. More information about this criterion is in the protocol.
- Pregnant, breastfeeding, or unwilling to use effective contraception throughout the study and 4 months after study completion
- Active infection, including hepatitis B, hepatitis C, HIV, or tuberculosis. More information about this criterion is in the protocol.
- Negative for Epstein-Barr virus by IgG determination
- Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within one year prior to study enrollment
- History of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- Known active alcohol or substance abuse
- Baseline Hgb below the lower limits of normal, lymphopenia, neutropenia, or thrombocytopenia
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ali Naji, MD, PhD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2007
First Posted
May 2, 2007
Study Start
November 1, 2006
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
March 21, 2016
Record last verified: 2016-02