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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT00530686
• Date of registration: 13/09/2007
• Primary sponsor: Baylor Research Institute
• Public title: Pancreatic Islet Cell Transplantation - A Novel Approach to Improve Islet Quality and Engraftment
• Scientific title: Pancreatic Islet Cell Transplantation - A Novel Approach to Improve Islet Quality and Engraftment
• Date of first enrolment: April 2007
• Target sample size: 15
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00530686
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Kerri Purcell, RN, BSN

• Name: Kerri Purcell, RN, BSN

• Name: Marlon Levy, MD
• Affiliation: Baylor All Saints

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Islet Cell Transplantation

Type 1 Diabetes

Intervention(s)

Drug: Islet cell transplantation

Primary Outcome(s)

To assess the achievement of insulin independence at 12-month and 24-month post transplant in patients who undergo pancreatic islet cell transplantation. [Time Frame: 12 months and 24 months]

Secondary Outcome(s)

1) Presence or absence of hypoglycemic unawareness 2) To assess incidence of hypoglycemic episodes 3) To assess insulin requirements in patients who did not become insulin independent [Time Frame: 24 months]

Secondary ID(s)

Baylor IRB #008-095

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Baylor Health Care System