Islet Transplant in Patients With Type I Diabetes
A Phase I/II, Open-Arm Study Evaluating the Safety of Islet Transplant in Patients With Type I Diabetes
1 other identifier
interventional
10
1 country
1
Brief Summary
The primary objective of this study is to demonstrate the safety of allogenic islet transplantation in type 1 diabetic patients performed at the University of Virginia. The purpose is to demonstrate that islet transplantation can be performed safely and reliably achieves better glycemic control than state-of-the-art insulin treatment in management of type 1 diabetic patients with brittle control and a history of severe hypoglycemic episodes with hypoglycemia unawareness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2019
Longer than P75 for phase_1
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
First Submitted
Initial submission to the registry
October 4, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJuly 30, 2020
July 1, 2020
2.3 years
October 4, 2018
July 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of procedure related adverse events
as evidenced by lack of bleeding during the procedure, incidence of portal vein thrombosis, incidence of biliary puncture during the procedure, incidence of wound complication for cases where laparotomy is performed, and incidence of increased transaminase levels \>5 times upper limit of normal within 6 months.
within 1 year of transplant
Secondary Outcomes (3)
Proportion of subjects with HbA1c less than or equal to 7.0%
within 1 year of transplant
Proportion of subjects free of severe hypoglycemic events between 6 and 12 months from the time of first islet cell infusion or from the time insulin therapy is withdrawn
within 1 year of transplant
Insulin independence achieved
within 1 year of transplant
Study Arms (1)
Allogenic Islet Cell Transplantation
EXPERIMENTALTransplantation of allogenic islet cell will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.
Interventions
Transplantation of allogenic islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.
Eligibility Criteria
You may qualify if:
- At least 1 episode of severe hypoglycemia in the past 3 years
- Reduced awareness of hypoglycemia
- Must be a qualified candidate for pancreas transplant
You may not qualify if:
- Diagnosis of co-existing cardiac diseased (ie, recent myocardial infarction within 6 months or angiographic evidence of non-correctable coronary artery disease or evidence of ischemia on functional cardiac exam
- Active alcohol or substance abuse
- Psychiatric disorder this is unstable or uncontrolled on current medication
- History of non-compliance
- Active infection including hepatitis C, hepatitis B, HIV
- History of or active Tuberculosis
- Any history of cancer, except skin cancer
- History of stroke within past 6 months
- BMI \> 27 kg/m2
- C-peptide fasting response to glucagon stimulation
- Inability to provide informed consent
- Creatinine Clearance \< 60 ml/min
- Macroalbuminuria
- Baseline Hb \<12 gm/dL
- Baseline liver function test outside normal ranges
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Department of Surgery
Study Record Dates
First Submitted
October 4, 2018
First Posted
October 9, 2018
Study Start
August 1, 2019
Primary Completion
November 1, 2021
Study Completion
December 1, 2023
Last Updated
July 30, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share