Status:
COMPLETED
Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Boston Area Diabetes Endocrinology Research Center (funded by NIDDK)
Conditions:
Diabetes Mellitus, Type I
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant. The primary objectives of the study are: \- To...
Detailed Description
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit ...
Eligibility Criteria
Inclusion
- Male and female subjects
- Age 18 to 70 years of age
- Have insulin dependent Diabetes Mellitus Type 1
- Are post-renal transplant on maintenance immunosuppression with stable renal function
- HbA1c \> 7.5% or \< 7.5% and hypoglycemia unawareness
Exclusion
- Weight more than 90 kg
- Insulin requirement \> 60 Units/day
- Other (non-kidney) organ transplants except prior failed pancreatic graft.
- Untreated or unstable proliferative diabetic retinopathy
- Presence of de novo antibody production since the renal allograft or either Class I or Class II panel-reactive anti-HLA antibodies
- Active infection
- Negative screen for Epstein-Barr virus (EBV)
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- History of Factor V Leiden mutation
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g. warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with international normalized ratio (INR) \> 1.5
- Severe co-existing cardiac disease
- Persistent elevation of liver function tests at the time of study entry
- Acute or chronic pancreatitis
- Male subjects with elevation of prostate specific antigen
- Pregnancy
- Positive screen for polyoma (BK) virus
- Untreated hyperlipidemia
- Recent hemorrhagic stroke
- Factors associated with an increased risk of bleeding
- Contact PI for complete Incl-Excl criteria list.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00888628
Start Date
May 1 2009
End Date
August 1 2016
Last Update
November 29 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114