Status:
COMPLETED
Pancreatic Islet Cell Transplantation
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
Baylor Health Care System
University of Miami
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 processin...
Detailed Description
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 processin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Substance/alcohol abuse
- Untreated proliferating diabetic retinopathy aa) Purified protein derivative (PPD) conversion or positive PPD without isonicotinic acid hydrazide (INH) bb) No Primary care physician or primary care physician less than 6 months cc) Smoking in the last 6 months dd) Abnormal Complete Blood Count (CBC) / Hemoglobin \< 12 g/dL ee) Macroalbuminuria \> 300 mg/24 hours ff) History of thyroid disease other than autoimmune disease gg) Untreated hyperlipidemia - Total Cholesterol (TC) \> 240 mg/dL, Triglycerides (TGC) \> 200 mg/dL, Low Density Lipoprotein (LDL) \> 140 mg/dL hh) Untreated hyponatremia, hypokalemia, hypercalcemia, hypocalcemia ii) Iodine contrast allergy jj) Prostate Specific Antigen (PSA) \> 4 kk) Panel Reactive Antibody (PRA) \> 20% ll) Active peptic ulcer disease/gallstones/hemangioma mm) Abnormal mammogram
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00214786
Start Date
April 1 2005
End Date
July 1 2007
Last Update
June 14 2017
Active Locations (1)
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1
Baylor Regional Transplant Institute - Baylor University Medical Center
Dallas, Texas, United States, 75246