- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02213003
Allogeneic Islet Cells Transplanted Onto the Omentum
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Diabetes Research Institute, University of Miami Miller School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female patients age 18 to 65 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Type1 diabetes with onset of disease at <40 years of age, insulin-dependence for > 5 years at the time of enrollment
- Absent stimulated c-peptide (<0.3ng/mL) in response to a mixed meal tolerance test.
- Involvement in intensive diabetes management
- At least one episode of severe hypoglycemia in the 12 months prior to study enrollment.
- Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more OR A Hypoglycemia score greater than or equal to the 90th percentile (1047) during the screening period; OR Marked glycemic lability and defined by a lability index score greater than or equal to the 90th percentile (433 mmol/L2/h•wk-1) during the screening period; OR A composite of a Clarke score of 3 or less and a hypoglycemia score greater than or equal to the 75th percentile (423) and a lability index greater than or equal to the 75th percentile (329) during the screening period.
- Subjects screening data from 20053135 protocol will be accepted for subjects eligible for this study. If 20053135 visit was 12 months prior to enrollment, Visit 2 laboratory should be repeated.
Exclusion Criteria:
- Body Mass Index (BMI) >30 kg/m2 or patient weight ≤50 kg.
- Insulin requirement of >1.0 IU/kg/day or <15 U/day.
- HbA1c >10%.
- Untreated proliferative diabetic retinopathy.
- Blood Pressure: SBP >160 mmHg or DBP >100 mmHg.
- Glomerular filtration rate <80 mL/min/1.73 m2 (calculated).
- Presence or history of macroalbuminuria (>300mg/g creatinine).
- Presence or history of panel-reactive anti-HLA antibodies.
- For female subjects: Serum or urine Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. If sexually active, subject must use at least two medically accepted methods of birth control.
- Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
- Negative screen for Epstein-Barr Virus (EBV) by IgG determination.
- Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within one year prior to study enrollment.
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
- Active alcohol or substance abuse.
- Hb below the lower limits of normal at the local laboratory; lymphopenia (<1,000/µL), neutropenia (<1,500/µL), or thrombocytopenia (platelets <100,000/µL).
- A history of Factor V deficiency.
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy.
Severe co-existing cardiac disease,
- recent myocardial infarction (within past 6 months)
- evidence of ischemia on functional cardiac exam within the last year) left ventricular ejection fraction <30%.
- Persistent elevation of liver function tests at the time of study entry.
- Symptomatic cholecystolithiasis.
- Acute or chronic pancreatitis.
- Symptomatic peptic ulcer disease.
- Gastrointestinal disorders potentially interfering with the ability to absorb oral medications.
- Hyperlipidemia despite medical therapy (fasting LDL cholesterol > 130 mg/dL, fasting triglycerides > 200 mg/dl).
- Chronic use of systemic steroids, except for the use of ≤5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only.
- Treatment with any anti-diabetic medications other than insulin within 4 weeks of enrollment.
23. Use of any investigational agents within 4 weeks of enrollment. 24. Administration of live attenuated vaccine(s) within 2 months of enrollment. 25. Any medical condition that, in the opinion of the investigator, will interfere with the safe participation in the trial.
26. Treatment with any immunosuppressive regimen at the time of enrollment. 27. A previous islet transplant. 28. A previous pancreas transplant 29. Inflammatory bowel disease. 30. History of intestinal obstructions. 31. Previous major abdominal surgery. 32. History of peritonitis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Islet transplantation
Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum.
|
Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A1c </= 6.5% and no severe hypoglycemia
Time Frame: 1 year
|
composite outcome
|
1 year
|
procedural complications
Time Frame: 1 year
|
safety
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rodolfo Alejandro, University of Miami
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20140144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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