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Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression Clinical research trials and Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression. Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression clinical trial. Participants oftentimes recieve the most expert healthcare available for their Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression  Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression
Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression
For Condition: Diabetes Mellitus, Type 1
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details: The trial may/will utilize the following immunosuppressive medications: tacrolimus (life-long), sirolimus (life-long), daclizumab and infliximab You will be maintained on the lowest doses possible with all the medications. GROUP (1A): The first four participants will be assigned to Group A. These participants will receive an islet cell transplant alone from two donors. They will receive the following immunosuppressive medications: tacrolimus (lifelong), sirolimus (lifelong), and daclizumab. They will not receive the immunosuppressive medication infliximab. GROUP (1B): The second four participants will be assigned to group B. These participants will receive an islet cell transplant alone from one donor. They will receive the following immunosuppressive medications: tacrolimus (lifelong), sirolimus (lifelong), daclizumab and infliximab. Patients in this group who are not able to stop injecting insulin by three months after the transplant may be eligible to receive a second islet cell transplant. Further participants will alternate group assignments in the same above-mentioned manner. The participants in both groups will receive the following immunosuppressive medications for life, tacrolimus and sirolimus. All participants will be required to live no more than two hours from the transplantation center. When the islets become available, you will be notified to come immediately to the hospital for your transplant. At that time numerous tests and laboratory samples will be performed to make sure you are ready and healthy for your transplant. You will have your islet cell transplant done in a special radiology procedure room in a hospital. You will have local anesthetic in the area of your liver on your right side along with sedatives that will minimize any discomfort the procedure might cause. A very small (thin) needle will be inserted through your liver into your portal vein where the islet cells are then injected. All participants will need to be followed at the Diabetes Research Institute after transplant for laboratory sampling, testing and for general islet cell transplant care.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 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. 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RodolfoAlejandro, Study Director, University of Miami Diabetes Research Institute
University of Miami Diabetes Research Institute
Miami, Florida, 33136
United States
Additional Information:
Study ID Numbers: DK55347; DK55347
Study Start Date: July 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021788
Other Diabetes Mellitus, Type 1 Studies:
1. Islet Transplantation for patients with Type 1 diabetes
2. Matrix metalloproteinases and Diabetic Nephropathy
3. Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
4. The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
5. Evaluation of the Effect of Pramlintide on Satiety and Food Intake
Related Studies:
Other Diabetes Mellitus, Type 1 Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression
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