Type 1 diabetes MedDRA version: 17.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: THYMOGLOBULIN®
Product Name: THYMOGLOBULINE
Pharmaceutical Form: Injection
Trade Name: NEULASTA®
Product Name: Neulasta
Pharmaceutical Form: Solution for injection
Trade Name: RAPAMUNE®
Sponsors
IRCCS Ospedale San Raffaele
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females aged 18-45 years - Ability to provide written informed consent - Mentally stable and able to comply with the procedures of the Protocol for the duration of the study, including follow-up visits and examinations scheduled - T1D new onset (diagnosis of diabetes within 180 days prior to enrollment). - Function beta cell residual (C-peptide fasting> 0.3 ng / mL in plasma glucose levels> 70 mg / dL and =200 mg / dL). - Positivity for at least one of the following autoantibodies typically associated with T1D: anti-GAD, anti-IA-2, anti ZnT8, IAA. A person who is positive for IAA and negative for other autoantibodies is not admissible if used insulin for more than 7 days. - Ongoing treatment with insulin, or has required insulin therapy (for 7 days) for diabetes at some time between the date of diagnosis and recruitment - Incompatibility for MHC class IA and B and compatibility for MHC class II DR with the donor of islet Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Body mass index (BMI) = 32.0 kg / m2 or patient = 50kg weight - Requirement of insulin> 1.0 IU / kg / day - HbA1c> 10% - Blood pressure: systolic> 160 mmHg or diastolic blood pressure> 100 mmHg. - Chronic disease than type 1 diabetes. - Moderate and severe renal impairment (creatinine clearance 300 mg / g creatinine). - Hepatic dysfunction defined by an increase in ALT / AST above the limit of the normal value and increases in total bilirubin> 3 mg / dl - Pregnant or breast-feeding. - Reluctance to use effective contraception up to 4 months after the end of the administration of the study drug (females and males) - Active infection including hepatitis B, hepatitis C, HIV or tuberculosis (TB). Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection. - Negative for Epstein-Barr Virus (EBV) to the determination of IgG - Invasive aspergillosis, histoplasmosis, coccidioidomycosis year prior to study enrollment - Any history of malignancy except basal or squamous cell carcinoma of the skin eradicated - Alcohol or substance abuse known active - Haemoglobin base below the lower limit of normal; lymphopenia ( 1.5 - Heart Disease serious coexisting: recent myocardial infarction (within the last 6 months) left ventricular ejection fraction 130 mg / dL, treated or untreated, and or fasting triglycerides> 200 mg / dL) - Treatment for a medical condition requiring chronic use of systemic steroids, except for the use of 5 mg of prednisone per day, or an equivalent dose of hydrocortisone, for the replacement saline. - Treatment with any anti-diabetic drug other than insulin within 4 weeks of enrollment - Use of investigational drugs within 4 weeks of enrollment. - The administration of live attenuated vaccine within 2 months thereafter - Any medical condition that, in the opinion of the investigator, would interfere with the safe participation in the study. - Treatment with any immunosuppressive regimen at enrollment
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in the insulin secretory response evaluated as Area Under the Curve (AUC) to two hours of C-peptide plasma in response to mixed meal (MMTT) one year after transplant Change from baseline C-peptide stimulated (the highest value at any point in time during the MMTT after injection mixed meal) Change from baseline in the secretory response gucagone evaluated as Area Under the Curve (AUC) to two hours of C-peptide plasma in response to mixed meal (MMTT);Timepoint(s) of evaluation of this end point: Weeks: 4 ± 1, 12± 2, 26±2 Weeks: 4 ± 1, 12± 2, 26±2, 52 ± 2 Weeks: 4±1, 12±2, 26±2, 52±2 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to test the efficacy and safety of a marginal islet transplantation associated with immunosuppressive treatment / modulatory transient therapy for type 1 diabetes onset;Secondary Objective: - Assess the impact of treatment on the immune response of memory and autoimmune in new onset type 1 diabetes - Identify biomarkers that reflect the sensitivity or resistance to the potential benefits of treatment on ß-cell function ;Primary end point(s): Change from baseline in the insulin secretory response evaluated as Area Under the Curve (AUC) to two hours of C-peptide plasma in response to mixed meal (MMTT) The incidence and severity of adverse events (AE) on the procedure for islet transplantation or treatment-related immunosuppressive;Timepoint(s) of evaluation of this end point: Week 52 ± 2 Weeks 4 ± 1, 12± 2 and week 52 ± 2 | — |
Countries
Italy
Contacts
Public ContactMedicina Generale Indirizzo Diabeto
IRCCS Ospedale San Raffaele
Outcome results
None listed