Pancreatic Islet Cell Transplantation - A Novel Approach to Improve Islet Quality and Engraftment

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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 processing with culture for pancreatic islet cell transplantation in human subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Collaborator: Baylor Health Care System

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

• Patient is expected to receive an islet cell transplant (up to 3 infusions) for type I diabetes mellitus

• Type I diabetes mellitus 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 from a diabetology care team

• Hypoglycemia unawareness, as defined by episodes of loss of cognitive function; or the inability to recognize glucose levels below 50 mg/dL; or frequent episodes of symptomatic hypoglycemia; or admission to the hospital for hypo/hyperglycemic

• Incapacitating signs and symptoms, as defined by the referring physician

• HbA1c > 6.5

• 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

• Patient has a known hypersensitivity to Tacrolimus, sirolimus, dacluzimab, 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

• Glofil or Creatinine Clearance < 60 mL/min

• Serum Creatinine > 1.6 mg/dL consistently

• Body mass index > 28

• Malignancy other than basal cell carcinoma or squamous cell carcinoma

• 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/dL

• HbA1c > 12%

• Insulin requirement >0.7 IU/kg/day

• Seropositivity for HIV, HBV, HCV, HTLV-1

• Abnormal Pap smear, active gynecological infection

• Positive exercise or chemical tolerance test

• Patients currently under treatment for a medical condition requiring chronic use of steroids at a dose of prednisone >5mg/day will be excluded

• Substance/alcohol abuse

• Untreated proliferating diabetic retinopathy

• PPD conversion or positive PPD without INH

• No Primary care physician or primary care physician less than 6 months

• Smoking in the last 6 months

• Abnormal CBC / Hemoglobin < 12 g/dL

• Macroalbuminuria > 300 mg/24 hours

• Untreated hyperlipidemia - TC > 200 mg/dL, TGC > 200 mg/dL, LDL > 130 mg/dL

• Untreated hyponatremia, hypokalemia, hypercalcemia, hypocalcemia

• Iodine contrast allergy

• PSA > 4

• PRA > 20%

• Active peptic ulcer disease/gallstones/hemangioma

• Abnormal mammogram