Status:
UNKNOWN
Heparinized Islets in Clinical Islet Transplantation
Lead Sponsor:
Corline Biomedical AB
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this study the islets will be surface modified to carry immobilised heparin (Corline Heparin Conjugate) prior to transplantation. The primary objective is to investigate safety and efficacy of allo...
Detailed Description
Transplantation of islets of Langerhans isolated from donated organs is a promising therapy for diabetes type 1. The results so far have, however, not met with the expectations due to relatively low e...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male and female patients age 18 to 65 years of age.
- Ability to understand and provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Clinical history compatible with type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years at the time of enrolment.
- Stimulated C-peptide \< 0.3 ng/mL (0.1 nmol/L) in response to a MMTT, before first islet transplantation.
- All subjects must have received medical treatment of their diabetes under the guidance from an experienced endocrinologist.
- If not previously transplanted the patient must also have;
- At least one episode of severe hypoglycaemia in the past 1 year defined as an event with at least one of the following symptoms; memory loss, confusion, uncontrollable behaviour, unusual difficulty in awakening, suspected seizure, loss of consciousness, or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood/plasma glucose level \< 54 mg/dl (3.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration OR
- Reduced awareness of hypoglycaemia as defined by a Clarke score of 4 or more.
- Exclusion Criteria
- Patients who meet any of these criteria are not eligible for participation in the study:
- Patients with prior organ transplants other than a kidney graft and/or islets.
- Patients with body mass index (BMI) \> 30.
- Insulin requirement \> 1 Unit/kg/day at screening.
- Consistently abnormal liver function tests (\> 1.5 x ULN on two consecutive measurements \> 2 weeks apart), at screening.
- Proliferative untreated diabetic retinopathy
- Increased risk for thrombosis (ex. homozygous APC-resistance) or bleeding (INR\>1.5)
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- Patients with increased cardiac risk defined as;
- unstable coronary artery disease requiring hospitalization or revascularization within 6 months prior to baseline visit
- chronic heart failure which required hospitalization 30 days prior to baseline visit
- Patients with active infections, unless treatment is not judged necessary by the investigators
- Patients with serological evidence of infection with HIV, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
- Patients with active peptic ulcer disease, symptomatic gallstones or portal hypertension.
- Patients who are pregnant or breastfeeding, or who intend to become pregnant.
- Sexually active females who are not:
- post-menopausal,
- surgically sterile, or
- using a highly effective method of contraception, such as: intra uterine device, oral contraceptives, implants, injectables or barrier devices combined with spermicidal gel
- Active alcohol or substance abuse
- Patients with evidence of high-level sensitization (PRA\> 50% with flow cytometry).
- Patients with psychological conditions that make it unsafe to undergo islet transplantation or which preclude compliance with prescribed therapy
- HbA1c \>11% (International standard) corresponding to IFCC calibration 97 mmol/mol, at screening.
- Medical history of egg allergy
- Patients with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo an islet transplant
- Patients participating in or having participated in any other clinical drug studies in the past four weeks.
Exclusion
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00678990
Start Date
January 1 2019
End Date
December 1 2019
Last Update
December 10 2018
Active Locations (2)
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1
Department of Transplantation Surgery, Karolinska University Hospital
Stockholm, Sweden, SE-141 86
2
Department of Transplantation and Liver Surgery, Uppsala University Hospital
Uppsala, Sweden, SE-751 85