Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Weill Medical College of Cornell University |
---|---|
Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00303134 |
The purpose of this study is to test the safety and efficacy of islet cell transplants for the treatment of type
1 diabetes mellitus. It has been shown that normal control of blood sugar levels can prevent progression of complications (such as kidney disease, nerve damage, and vascular disease) from diabetes. This research study is designed to see if normal blood sugar control can be achieved by transplanting pancreatic islet cells into your liver, which may reduce or eliminate your need for insulin. Patients may qualify to participate in this research study if they have type 1 diabetes mellitus for at least five years and meet at least one of the following criteria:
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 |
Procedure: Islet Cell Transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Human Islet Cell Transplantation in Type 1 Diabetic Patients |
Estimated Enrollment: | 8 |
Study Start Date: | August 2003 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If an endocrinologist did not participate in the ongoing management effort during the past year, then an independent endocrinologist must assess the adequacy of the management efforts prior to enrollment.) The complicating situations are:
i) Retinopathy—a minimum of a three step progression using the Early Treatment Diabetic Retinopathy Study (ETDRS) grading system 44,or an equivalent progression as certified by an ophthalmologist familiar with diabetic retinopathy, or ii) Nephropathy—a confirmed rise of 50 µg/min (72 mg/24h) of microalbuminuria or greater over at least three months (beginning anytime within the past two years) despite the use of an ACE inhibitor, or
iii) Neuropathy—persistent or progressing autonomic neuropathy (gastroparesis, postural hypotension, neuropathic bowel or bladder) or persistent or progressing severe peripheral painful neuropathy not responding to usual management (e.g., tricyclics, gabapentin, or carbamazepine).
Exclusion Criteria:
Severe co-existing cardiac disease, characterized by any one of these conditions:
Active alcohol or substance abuse-includes cigarette smoking (must be abstinent for six months). Active alcohol abuse should be considered using the current NIAAA definitions, whereby alcohol abuse is defined by a pattern of drinking that is accompanied by one or more of the following situations within a 12-month period:
Under treatment for a medical condition requiring chronic use of steroids aa. Use of coumadin or other anticoagulant therapy (except aspirin) or subject with PT/INR >1.5
27. Addison's disease. All subjects should be screened with a basal 8:00 a.m. cortisol test. Results less than the lower limit of normal indicate further testing (e.g., a Cortrosyn stimulation test) to rule out adrenal insufficiency. Abnormal ACTH stimulation test will be an exclusion criterion.
United States, New York | |
New York Presbyterian Hospital - Weill Cornell Medical Center | |
New York, New York, United States, 10021 |
Study Director: | Dolca A Thomas, M.D. | New York Presbterian Hospital - Weill Cornell Medical Center |
Principal Investigator: | Manikkam Suthanthiran, M.D. | New York Presbyterian Hospital - Weill Cornell Medical Center |
Study ID Numbers: | 0105004956 |
Study First Received: | March 13, 2006 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00303134 History of Changes |
Health Authority: | United States: Food and Drug Administration |
islet cell diabetes transplant |
immunosuppression autoimmunity alloimmunity |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |