Heparinized Islets in Clinical Islet Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00678990
• Date of registration: 14/05/2008
• Prospective Registration: Yes
• Primary sponsor: Corline Biomedical AB
• Public title: Heparinized Islets in Clinical Islet Transplantation
• Scientific title: Open Study to Evaluate Safety and Efficacy of Allogenic Islet Transplantation Using Islets Coated With Immobilised Heparin
• Date of first enrolment: January 2019
• Target sample size: 10
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT00678990
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Tomas Lorant

• Name: Tomas Lorant
• Affiliation: Uppsala University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria

1. Male and female patients age 18 to 65 years of age.

2. Ability to understand and provide written informed consent.

3. Mentally stable and able to comply with the procedures of the study protocol.

4. 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.

5. Stimulated C-peptide < 0.3 ng/mL (0.1 nmol/L) in response to a MMTT, before first
islet transplantation.

6. 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;

7. 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

8. 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:

1. Patients with prior organ transplants other than a kidney graft and/or islets.

2. Patients with body mass index (BMI) > 30.

3. Insulin requirement > 1 Unit/kg/day at screening.

4. Consistently abnormal liver function tests (> 1.5 x ULN on two consecutive
measurements > 2 weeks apart), at screening.

5. Proliferative untreated diabetic retinopathy

6. Increased risk for thrombosis (ex. homozygous APC-resistance) or bleeding (INR>1.5)

7. Any history of malignancy except for completely resected squamous or basal cell
carcinoma of the skin

8. Patients with increased cardiac risk defined as;

1. unstable coronary artery disease requiring hospitalization or revascularization
within 6 months prior to baseline visit

2. chronic heart failure which required hospitalization 30 days prior to baseline
visit

9. Patients with active infections, unless treatment is not judged necessary by the
investigators

10. 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.

11. Patients with active peptic ulcer disease, symptomatic gallstones or portal
hypertension.

12. Patients who are pregnant or breastfeeding, or who intend to become pregnant.

13. Sexually active females who are not:

1. post-menopausal,

2. surgically sterile, or

3. using a highly effective method of contraception, such as: intra uterine device,
oral contraceptives, implants, injectables or barrier devices combined with
spermicidal gel

14. Active alcohol or substance abuse

15. Patients with evidence of high-level sensitization (PRA> 50% with flow cytometry).

16. Patients with psychological conditions that make it unsafe to undergo islet
transplantation or which preclude compliance with prescribed therapy

17. HbA1c >11% (International standard) corresponding to IFCC calibration 97 mmol/mol, at
screening.

18. Medical history of egg allergy

19. Patients with any condition or any circumstance that in the opinion of the
investigator would make it unsafe to undergo an islet transplant

20. Patients participating in or having participated in any other clinical drug studies in
the past four weeks.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Procedure: Transplantation of islets with heparin coating

Primary Outcome(s)

Safety [Time Frame: 105 days]

Secondary ID(s)

SAL-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors