Islet Cell Transplantation Alone in Patients With Type I Diabetes Mellitus: Steroid-free Immunosuppression

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

The goal of islet cell transplantation in patients with Type 1 Diabetes Mellitus is to provide constant normal blood glucose levels. This may eliminate the need for insulin altogether or provide a significant reduction in the amount of insulin necessary to maintain constant normal blood glucose levels. This normalization may prevent or slow progression of diabetic complications. Furthermore, the participant may enjoy a healthier lifestyle and a better quality of life. If you meet the initial inclusion criteria for the trial, you must be able to give informed consent personally. Then you will need to participate in an extensive screening process that involves many standard tests and collection of laboratory samples to make sure that the transplant is suitable and safe for you.

Key facts

Study ID

NCT00021788

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Starts

2000-07-01

Expected to finish

2001-12-01

Last updated by the study team

2010-07-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidates must be between the ages of 18 and 65
• Candidates must have had 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 insulin-dependent diabetes mellitus (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.

You may not qualify if…

• 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

Where it is running

• University of Miami Diabetes Research Institute — Miami, Florida, United States

Full record on ClinicalTrials.gov

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