Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation
Completed · Phase 2
Conditions studied: Type 1 Diabetes Mellitus
In brief
The purposes of this study are: 1. To reverse hyperglycemia and insulin dependency in patients with type 1 diabetes mellitus through islet transplantation utilizing steroid free, calcineurin-inhibitor free immunosuppression. 2. To assess the long-term function of successful islet transplants in patients with type 1 diabetes mellitus utilizing islets that have undergone a period of culture. 3. To determine whether the natural history of the microvascular, macrovascular, and neuropathic complications are altered following the successful transplantation of islets.
Key facts
- Study ID
- NCT00315627
- Run by
- Rodolfo Alejandro
- People needed
- 3
- Starts
- 2005-07-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2017-05-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Potential candidates must have type 1 diabetes mellitus and fulfill one or more of the following:
- Manifest signs and symptoms that are severe enough to be incapacitating. Incapacitating signs and symptoms include hypoglycemic episodes requiring assistance by others and hypoglycemia unawareness (the inability to recognize low blood glucoses; glucoses < 54 mg/dl). These patients are at high risk for involvement in accidents (they can lose consciousness or act irrationally), thus causing harm to themselves and/or others.
- Patients with poor diabetes control (HbA1c > 8.0% but < 12%), despite intensive insulin therapy, as defined by: self monitoring of blood glucose ≥ 4 times/day, multiple insulin injections (≥ 3/day) or insulin pump, and close monitoring of blood glucose control by an endocrinologist. These patients can experience acute, rapid hyperglycemia secondary to several stress factors, that can lead to dehydration, disorientation, and in some instances, ketoacidosis.
- Progressive diabetic complications. These patients with chronically poor glycemic control are at higher risk for the development of a wide variety of complications (retinopathy, neuropathy, nephropathy, and cardiovascular disease) associated with diabetes.
You may not qualify if…
- Potential candidates will be excluded as per the following criteria:
- Age < 18 or > 65 years
- Duration of diabetes < 5 years
- Do not have a physician that is monitoring diabetes for > 6 months
- Body mass index > 26
- Weight > 80 kg
- Insulin requirement > 1.0 u/kg/d
- HbA1c > 12%
- Stimulated or basal C-peptide > 0.3 ng/ml
- Corrected creatinine clearance < 60 ml/min
- Serum creatinine consistently above 1.6 mg/dl
- Macroalbuminuria (> 300 mg/24 hours)
- Anemia (hemoglobin < 12.0 g/dl for males; < 11 g/dl for females)
- Hyperlipidemia (fasting low-density lipoprotein [LDL] cholesterol > 130 mg/dl and/or fasting triglycerides > 200 mg/dl)
- Abnormal liver function tests (consistently > 1.5 x normal range)
- Serological evidence of HIV, HBsAg and/or HBcAb, HBsAb without history of vaccination, human t cell lymphotropic virus 1 (HTLV-1), or hepatitis C virus (HCV)
- Negative serology for Epstein-Barr virus (EBV) or evidence of acute or chronic infection (IgM ≥ IgG)
- Lack of updated immunizations per current Centers for Disease Control (CDC) guidelines (including lack of immunization against hepatitis B, pneumococcus and influenza - during season)
- Presence of panel reactive antibodies > 20%
- Prostate-specific antigen (PSA) > 4 ng/ml unless malignancy is ruled out
- Positive tuberculin test (unless proof of adequate treatment for latent tuberculosis can be provided)
- X-ray evidence of pulmonary infection or other significant pathology
- Gall stones and/or portal hypertension and/or hemangioma on liver ultrasound
- Abnormal abdominal or pelvic ultrasound (evidence of masses that are considered suspicious for malignancy or adenopathy)
- Active peptic ulcer disease
Where it is running
- Diabetes Research Institute — Miami, Florida, United States
Full record on ClinicalTrials.gov
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