Pancreatic Islet Cell Transplantation After Kidney Transplantation - A Novel Approach to Immunosupression
Islet Cell Transplantation, Type 1 Diabetes
About this trial
This is an interventional treatment trial for Islet Cell Transplantation focused on measuring Diabetes Mellitus, Hypoglycemia, Hyperglycemia, Type 1 Diabetes, Islet Cell Transplantation
Eligibility Criteria
Inclusion Criteria:
- Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 24 months.
- Type 1 diabetes mellitus of more than 5 years duration
- Age between 18 and 65
Unstable diabetes mellitus control despite expert management by a diabetology care team for at least 6 months prior to consideration for transplantation as defined by the following:
- During the past six months (or during the period of intensive diabetes care): Any episodes of hypoglycemic unawareness, as defined by the inability to recognize glucose levels below 50 mg/dL; or episodes of loss of cognitive function; or frequent episodes of symptomatic hypoglycemia; or admission to the hospital for hypo- or hyperglycemia; and
- HbA1C>6.5%.
- Patient underwent kidney transplantation at least six months before enrollment, and has stable kidney allograft function, defined as creatinine levels of maximum 2 mg/dl, stable renal allograft function as assessed by the transplant nephrologist, and has a creatinine clearance of more than 40 ml/min.
- 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 Criteria:
Patient has previously received or is receiving an organ or bone marrow transplant other than a first kidney transplant.
2. Patient has a known hypersensitivity to Tacrolimus, Sirolimus, Alemtuzumab, or Mycophenolate (allow substitution of Myfortic for CellCept).
3. Patient is pregnant or lactating (must provide effective contraception method).
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. Patient exhibits any one of the following clinical criteria:
- Creatinine clearance or Glofil test < 40 mL/min
- Serum creatinine > 2.0 mg/dL consistently, or more than 0.2 mg/dl increase in creatinine over the last five months
- Body mass index > 28
- Malignancy other than BCC and SCC
- Radiographic evidence of pulmonary infection
- Evidence of liver disease as evidenced by >2X ULN for AST, ALT, Alk. Phos., or T. bili.
- Active infections
- Hypercoagulable states (history of recurrent venous thrombosis, defined thrombophilia)
- Bleeding / coagulation disorders
- Basal C-peptide > 0.3 ng/mL
- HbA1C >12%
- Insulin requirement > 1 IU/kg/day
- Seropositivity for HIV, HBV, HCV, HTLV-I
- Abnormal Pap smear, active gynecological infection
- Positive exercise or chemical cardiac tolerance test
- Patients currently under treatment for a medical condition requiring chronic use of steroids at a dose of prednisone >10 mg/day will be excluded.
- Substance/alcohol abuse
- Untreated proliferating diabetic retinopathy
- PPD conversion or positive PPD without INH if suspicious TB by chest X-ray or symptoms
- No primary care physician or primary care physician less than 6 months
- Smoking in the last 6 months
- Abnormal CBC / Hemoglobin < 10 g/dL
- Microalbuminuria > 300 mg/24 hrs
- Untreated hyperlipidemia - TC > 200 mg/dL, TGC > 200 mg/dL, LDL > 130 mg/dL
- Untreated hyponatremia, hypokalemia, hypercalcemia, hypocalcemia
- Iodine contrast allergy
- PSA > 4 ng/mL
- PRA > 20%
- Active peptic ulcer disease/gallstones/hemangioma
- Abnormal mammogram.
- Patient receives any of the prohibited medications
Sites / Locations
- Baylor University Medical Center