Islet Cell Transplantation Alone and CD34+ Enriched Bone Marrow Cell Infusion in Patients With Diabetes Mellitus: Steroid-Free Regimen

Inclusion criteria

• Candidates must be between the ages of 18 and 50.
• Candidates must have had insulin-dependent diabetes mellitus (IDDM) for at least 5 years and been under physician care for at least 6 months prior to enrollment in trial.
• Eligible candidates will have poorly controlled IDDM and manifest signs and symptoms severe enough to be incapacitating. These symptoms can include episodes of hypoglycemic unawareness (failure to recognize blood glucose levels < 54 mg/dl) or episodes requiring the assistance of others.
• Candidates may have poor diabetes control despite intensive insulin therapy (HbA1c > 8.0%).
• Creatinine clearance should be > 60 ml/min)
• Body Mass Index should be less than 26
• Women of child-bearing age must have a negative pregnancy test and agree to follow effective contraceptive measures for the duration of the trial.

Exclusion criteria

• Previous or concurrent organ transplant
• Previous or concurrent malignancy
• Untreated proliferative diabetic retinopathy
• Unstable cardiovascular status, including positive stress echocardiography (if > age 35)
• Active infections, including x-ray evidence of pulmonary infection
• Peptic ulcer disease, gall stones, or portal hypertension
• Abnormal liver function tests
• Presence of panel reactive antibodies > 20%
• Creatinine clearance < 60 ml/min
• HbA1c > 12%
• Serological evidence of HIV, HbsAg, or HCV
• Anemia (hemoglobin < 12.0)
• Any condition or circumstance, including psychogenic factors, that preclude therapeutic compliance or otherwise make it unsafe to undergo an islet cell transplant.
• PSA > 4 in males