Status:
COMPLETED
Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation
Lead Sponsor:
Rodolfo Alejandro
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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-inhibito...
Detailed Description
STUDY DESIGN: The initial proposal submitted to the JDRFI was to compare 3 different groups of patients receiving islet cell transplants utilizing steroid-free, calcineurin-free protocols. The 3 grou...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Active infections
- Unstable cardiovascular status (including positive stress echocardiography if age \> 35)
- Untreated or unstable proliferative diabetic retinopathy
- Previous/concurrent organ transplantation (except for failed islet cell or pancreas transplantation)
- Malignancy or previous malignancy
- Any medical condition requiring chronic use of steroids
- Active alcohol or substance abuse; smoking in the last 6 months.
- Sexually active females who are not:
- post-menopausal,
- surgically sterile, or
- not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices with spermicide are acceptable; condoms used alone are not acceptable)
- Positive pregnancy test or intent for future pregnancy, or male subject's intent to procreate
- Any condition or any circumstances that make it unsafe to undergo an islet cell transplant
- Psychogenically unable to comply
- Failed psychological evaluation
- Persistent leukopenia (white blood cell count \< 3,000/uL on more than 3 occasions)
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00315627
Start Date
July 1 2005
End Date
January 1 2014
Last Update
May 25 2017
Active Locations (1)
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1
Diabetes Research Institute
Miami, Florida, United States, 33136