Pancreatic Islet Cell Transplantation

Completed · Phase 1

Conditions studied: Type 1 Diabetes

In brief

The purpose of this study is to assess a novel approach to immunosuppression in allogenic pancreatic islet cell transplant recipients. In addition, the study aims to assess remote site islet processing with culture for pancreatic islet cell transplantation in human subjects.

Key facts

Study ID

NCT00214786

Run by

Baylor Research Institute

People needed

4

Starts

2005-04-01

Expected to finish

2007-07-01

Last updated by the study team

2017-06-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has been fully informed and has signed an Institutional Review Board (IRB) approved informed consent form and is willing and able to follow study procedures for the full 2 years
• Patient is expected to receive an islet cell transplant (up to 3 infusions) for type I diabetes mellitus
• Type I diabetes of more than 5 years duration
• Age between 18 and 65
• Unstable diabetes mellitus control, as defined by glucose measurements above 200 mg/dL and/or below 80 mg/dL despite adequate medical care
• Hypoglycemia unawareness, as defined by episodes of loss of cognitive function
• Incapacitating signs and symptoms, as defined by the referring physician
• Poor control of HbA1c > 8%
• Psychogenically able to comply, in the opinion of the investigator
• Female patients of childbearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion.

You may not qualify if…

• Patients meeting any of the following criteria will be excluded from study participation.
• Patient has previously received or is receiving an organ or bone marrow transplant
• Patient has a known hypersensitivity to Tacrolimus, sirolimus, daclizumab, or CellCept
• Patient is pregnant or lactating
• Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment
• Patient has participated in a trial involving a marketed drug or an infusion device within 30 days of the start of the trial
• Glomerular filtration rate (GLOFIL) < 60 mL/min
• Serum Creatinine > 1.6 mg/dL consistently
• Body mass index > 30
• Autoimmune thyroiditis
• Malignancy other than basal cell carcinoma or squamous cell carcinoma
• Radiographic evidence of pulmonary infection
• Evidence of liver disease
• Portal hypertension
• Active infections
• Hypercoagulable states (history of recurrent venous thrombosis, defined thrombophilia)
• Bleeding / coagulation disorders
• Basal insulin C-Peptide > 0.3 ng/dL
• Insulin C-peptide > 0.3 ng/dL during stimulation test
• HbA1c > 12%
• Insulin requirement > 1 IU/kg/day
• Seropositivity for Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Human T-cell leukemia virus-1 (HTLV-1)
• Abnormal Pap smear in the last two months, active gynecological infection
• Positive exercise or chemical tolerance test
• Steroid dependence

Where it is running

• Baylor Regional Transplant Institute - Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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