Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT01220856
Eligibility Criteria:
Inclusion criteria:
* Ages 18-65 years, inclusive.
* Patients eligible for pancreatic islet transplantation based on local accepted practice and guidelines. This includes at least: a)clinical history compatible with T1D with insulin-dependence for \>5 years; b) undetectable stimulated (arginine or MMTT) C-peptide levels (\<0.3 ng/mL) in the 12 months before transplant. Sites will comply with any additional or more stringent criteria locally accepted, as per centre practice.
* Patients with adequate renal reserve as per calculated creatinine clearance (CLcr) \> 60 mL/min according to the Cockcroft-Gault formula (1976).
* Planned intrahepatic islet transplantation alone from a non-living donor with brain death.
* Planned infusion of 4000 to 7000 islet equivalent (IEQ)/kg body weight.
* Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
* Patients given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Exclusion criteria:
* Recipients of any previous transplant, except from recipients of a previous pancreatic islet transplantation that has failed, are off immunosuppression since at least 1 year and have negative anti-HLA.
* Recipients of islet from a non-heart beating donor.
* A body mass index \>30 kg/m2 or patient weight \<45 kg.
* Pre-transplant average daily insulin requirement \>1 IU/kg/day.
* Pre-transplant HbA1c \>11%.
* Patients with hepatic dysfunction as defined by increased ALT/AST \> 3 x ULN and increased total bilirubin \> 3mg/dL \[\>51.3 micromol/L\]).
* Patients who receive treatment for a medical condition requiring chronic use of systemic steroids.
* Treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant.
* Use of any investigational agent within 4 weeks of enrolment.
* Hypersensitivity to:
* ibuprofen or to more than one non steroidal anti-inflammatory drug
* medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib.
* Pregnant or breast-feeding women; unwillingness to use effective contraceptive measures (females and males).
Sites will comply with any additional exclusion criteria locally accepted, as per centre practice.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01220856
Study Brief:
Protocol Section:
NCT01220856