An Open Label, Pilot Investigation, to Assess the Safety and Efficacy of Transplantation of Macro-encapsulated Human Islets Within the Bioartificial Pancreas Beta-Air in Patients With Type 1 Diabetes Mellitus
NCT ID: NCT02064309
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
4 participants
INTERVENTIONAL
2014-02-28
2025-05-31
Brief Summary
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The secondary objective of this clinical investigation is to investigate if the transplantation of macro-encapsulated human islets within the Beta-Air device can provide improved glycaemic control in type 1 diabetes patients with reduced incidences of hypoglycaemic episodes.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Human islets in Beta-Air device
Beta-Air device for encapsulation of transplanted human islets
Interventions
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Beta-Air device for encapsulation of transplanted human islets
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of type 1 diabetes mellitus for \> 5 years
3. Men or women \> 18 years of age at the time of enrolment
4. Involvement in intensive diabetes management defined as self-monitoring of blood glucose level no less than a mean of three times per day averaged over each week and by the administration of three or more insulin injections per day or insulin pump therapy. This management must be under the direction of a diabetologist or diabetes specialist during the 12 months prior to study enrolment.
Exclusion Criteria
2. Insulin requirement of \> 1.0 Units/kg/day
3. HbA1c \> 10 % (DCCT)
4. Random C-peptide \> 0.003 nmol/l
5. Known untreated active proliferative diabetic retinopathy changes or increasing macular oedema
6. Renal failure (Glomerular Filtration Rate \<60 ml/min)
7. Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or unwilling to use adequate contraceptive methods for the duration of the trial (implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner).
8. Active infection including hepatitis B, hepatitis C, HIV, Tbc
9. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
10. Known active alcohol or drug abuse.
11. Any coagulopathy or medical condition that would require long-term anticoagulant therapy (e.g., Warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with an international normalized ratio (INR) \> 1.5.
12. Severe co-existing cardiac disease, characterized by any of these conditions:
1. Recent myocardial infarction (within past 36 weeks)
2. Evidence of ischemia on functional cardiac exam within the last year
3. Left ventricular ejection fraction \< 30 %
4. Cardiovascular conditions within 36 weeks prior to this trial:
i. Decompensated heart failure New York Heart Association (NYHA) class III or IV ii. Unstable angina pectoris iii. Coronary arterial bypass graft iv. Coronary angioplasty
13. Inadequately treated blood pressure elevation (systolic BP \> 160 mmHg or diastolic blood pressure \> 100 mmHg)
14. Use of any medications to treat diabetes other than insulin within 4 weeks of enrolment
15. Administration of live attenuated vaccine(s) within 8 weeks of enrolment
16. Any previous organ transplant
17. Treatment with any immunosuppressive drug
18. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial (e.g., systemic glucocorticoids)
19. Known or suspected allergy of hypersensitivity to trial product(s) or related products
20. The receipt of any investigational product within 30 days of screening for this trial
21. Any scheduled transplant in addition to the islet transplantation
22. Fulfillment of criteria for clinical pancreas or islet transplantation
18 Years
ALL
No
Sponsors
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Beta-O2 Technologies Ltd.
INDUSTRY
Uppsala University Hospital
OTHER
Responsible Party
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Per-Ola Carlsson
Professor
Locations
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Uppsala University Hospital
Uppsala, , Sweden
Countries
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References
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Carlsson PO, Espes D, Sedigh A, Rotem A, Zimerman B, Grinberg H, Goldman T, Barkai U, Avni Y, Westermark GT, Carlbom L, Ahlstrom H, Eriksson O, Olerud J, Korsgren O. Transplantation of macroencapsulated human islets within the bioartificial pancreas betaAir to patients with type 1 diabetes mellitus. Am J Transplant. 2018 Jul;18(7):1735-1744. doi: 10.1111/ajt.14642. Epub 2018 Feb 2.
Other Identifiers
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AS Dnr2013/299
Identifier Type: -
Identifier Source: org_study_id