Type 1 Diabetes Clinical Trial
Official title:
Pancreatic Islet Cell Transplantation - A Novel Approach to Immunosuppression and Validation of Remote Site Islet Cell Processing, Islet Cell Culture and Two-Layer Preservation
Verified date | June 2017 |
Source | Baylor Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. 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 2. 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 3. 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 Criteria: Patients meeting any of the following criteria will be excluded from study participation. 1. Patient has previously received or is receiving an organ or bone marrow transplant 2. Patient has a known hypersensitivity to Tacrolimus, sirolimus, daclizumab, or CellCept 3. Patient is pregnant or lactating 4. Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment 5. Patient has participated in a trial involving a marketed drug or an infusion device within 30 days of the start of the trial 6. Glomerular filtration rate (GLOFIL) < 60 mL/min 7. Serum Creatinine > 1.6 mg/dL consistently 8. Body mass index > 30 9. Autoimmune thyroiditis 10. Malignancy other than basal cell carcinoma or squamous cell carcinoma 11. Radiographic evidence of pulmonary infection 12. Evidence of liver disease 13. Portal hypertension 14. Active infections 15. Hypercoagulable states (history of recurrent venous thrombosis, defined thrombophilia) 16. Bleeding / coagulation disorders 17. Basal insulin C-Peptide > 0.3 ng/dL 18. Insulin C-peptide > 0.3 ng/dL during stimulation test 19. HbA1c > 12% 20. Insulin requirement > 1 IU/kg/day 21. Seropositivity for Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Human T-cell leukemia virus-1 (HTLV-1) 22. Abnormal Pap smear in the last two months, active gynecological infection 23. Positive exercise or chemical tolerance test 24. Steroid dependence 25. Substance/alcohol abuse 26. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Baylor Regional Transplant Institute - Baylor University Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor Research Institute | Baylor Health Care System, University of Miami |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Achievement of Insulin Independence at 12-month Post Transplant | To assess the number of patients who achieve insulin independence at 12-month after islet cell transplantation | 12 months post transplant | |
Secondary | Presence or Absence of Hypoglycemic Unawareness | Number of patients who achieved absence of hypoglycemic unawareness | 12 months after transplantation | |
Secondary | Incidence of Hypoglycemic Episodes | Blood glucose <70 mg/dl, number of times reported per month | 12 months after transplantation | |
Secondary | Change of Insulin Requirements in Patients Who Did Not Become Insulin Independent | Percentage of insulin requirement at month 12 against that at baseline in the patients who did not achieve insulin independence. The percentage less than 100% indicates that subjects reduced insulin requirements 12 months after islet transplantation when compared with those at pre-transplant, while the parentage more than 100% represents that patients needed higher amount of exogenous insulin 12 months after islet transplantation. | 12 months after transplantation | |
Secondary | Islet Cell Mass Obtained After Remote Site Processing | The sum of Islet mass obtained after transport using the two-layer preservation method, remote site processing and islet culture. Islet mass as defined by Islet Equivalent per kilogram recipient body weight. | At transplantation | |
Secondary | The Number of Islet Cell Infusions Needed to Achieve Insulin Independence | 12 months after transplantation | ||
Secondary | Renal Function | Glomerular filtration rate measured by sodium iothalamate I-125 injection (GLOFIL) | 12 months after transplantation | |
Secondary | Morbidity Related to the Immunosuppression Regimen | Number of participants who experienced serious adverse events related to immunosuppression regimen | 12 months after transplantation | |
Secondary | Morbidity Related to the Islet Cell Infusion | Number of participants who experienced serious adverse events related to islet cell infusion | 12months after transplantation | |
Secondary | The Quality of Life of the Recipients Measured With the RAND 36-item Short Form Health Survey | Averaged score in subscales of 'physical functioning', 'Role limitations due to emotional problems', 'energy/fatigue', 'emotional well-being', 'social functioning', 'pain' and 'general health' in the RAND 36-item short form health survey (SF-36). Full scale range is 0-100 for all subscales with 100 as the best outcome and 0 as the worst outcome. | 12 months after transplantation |
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