Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
NCT ID: NCT00285233
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
8 participants
INTERVENTIONAL
2000-09-30
2005-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Allogeneic islets of Langerhans transplant
Allogeneic islets of Langerhans transplant
Interventions
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Allogeneic islets of Langerhans transplant
Allogeneic islets of Langerhans transplant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Type 1 diabetes mellitus, complicated by at least one of the following situations that persist despite intensive efforts in close cooperation with their diabetes care team:
1. Metabolic lability/instability;
2. Reduced awareness of hypoglycemia;
3. Persistently poor glucose control (as defined by HgbA1c\>10% at the end of six months of intensive management efforts with the diabetes care team);
4. Progressive secondary complications.
3. Age 18 and older
4. Able to give written informed consent
Exclusion Criteria
2. Presence of history of panel-reactive anti-HLA antibodies (\>10%).
3. Insufficient cardiovascular reserve.
4. Creatinine clearance \<60 mL/min/m2.
5. Portal hypertension, abnormal liver enzyme tests, or history of significant liver disease.
6. History of malignancy within 5 years.
7. Active peptic ulcer disease.
8. Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications.
9. Pregnancy or breast-feeding.
10. Active infections.
11. Serological evidence of infection with HIV, or HBsAg or HCVAb positive within the previous 12 months prior to transplantation.
12. Negative screen for Epstein-Barr Virus (EBV) by an EBNA method
13. Evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study screening.
14. Schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medications.
15. Ongoing substance abuse; drug or alcohol.
16. Recent history of noncompliance.
17. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
18 Years
65 Years
ALL
Yes
Sponsors
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Roche Pharma AG
INDUSTRY
Juvenile Diabetes Research Foundation
OTHER
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Bernhard J. Hering, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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Hering BJ, Kandaswamy R, Ansite JD, Eckman PM, Nakano M, Sawada T, Matsumoto I, Ihm SH, Zhang HJ, Parkey J, Hunter DW, Sutherland DE. Single-donor, marginal-dose islet transplantation in patients with type 1 diabetes. JAMA. 2005 Feb 16;293(7):830-5. doi: 10.1001/jama.293.7.830.
Related Links
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Diabetes Institute for Immunology and Transplantation - U of M
Other Identifiers
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0006M55241
Identifier Type: -
Identifier Source: org_study_id