Heparinized Islets in Clinical Islet Transplantation

NCT00678990 | Unknown DMC

• 1 other identifier: SAL-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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 allogeneic islet transplantation using islets coated with immobilised heparin. The modification with heparin has been shown to protect the islets from being attacked by the immediate defence systems in blood (coagulation and inflammation), so that a larger portion of the islets will survive the initial phase and engraft. Evaluation will be based on metabolic and blood chemistry parameters.

Conditions

Type 1 Diabetes Mellitus

Keywords

Islets of Langerhans; islets; heparin

Outcome Measures

Primary Outcomes (1)

• Safety

  Number of and grade of Serious Adverse events during the first 105 days after transplantation and Adverse events during the first 75 days after transplantation.

  105 days

Study Arms (1)

Open, single arm

EXPERIMENTAL

Transplantation of islets with heparin coating.

Procedure: Transplantation of islets with heparin coating

Interventions

Transplantation of islets with heparin coating PROCEDURE

Transplantation of islets with heparin coating

Open, single arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corline Biomedical AB: lead

Study Sites (2)

Department of Transplantation Surgery, Karolinska University Hospital

Stockholm, SE-141 86, Sweden

Location

Department of Transplantation and Liver Surgery, Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tomas Lorant

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Lorant

CONTACT

+46 18 6110000; tomas.lorant@surgsci.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 10, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)