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

NCT02064309 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: AS Dnr2013/299
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical investigation is to investigate the safety of implantation of the human islet containing device Beta-Air in type 1 diabetic subjects. 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.

Conditions

Long-standing Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Safety of device, as evaluated by incidence of adverse events or serious adverse events judged probable or highly probable related to the device

  0-365 days

Secondary Outcomes (8)

• 1. Incidence of local or systemic inflammation or infection, incl. C-reactive protein rise, judged related to the device during course of study.

  0-365 days

• 2. Incidence and severity of fibrosis surrounding the device during course of study.

  0-365 days

• 3. Signs of immunization in transplanted patients.

  0-365 days

• 4. Oxygenation of tissue in the device, as evaluated at 4, 12 and 26 weeks post-transplantation

  0-180 days

• 5. Survival of endocrine tissue in the device, as evaluated by [11C]-5-hydroxytryptophane positron emission tomography and histological analysis at 26 weeks post-transplantation.

  0-180 days

Other Outcomes (7)

• 1. Number of patients with daily insulin needs <0.25 Units/kg at 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 and 26 weeks post-transplantation

  0-26 weeks post-transplantation

• 2. Delta changes in insulin requirement/kg body weight at 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 and 26 weeks post-transplantation when compared to before transplantation and 6 months after explantation

  0-365 days

• 3. Delta changes in glycosylated hemoglobin (HbA1c) at 2, 4, 8, 12, 14, 18 and 26 weeks post-transplantation when compared to before transplantation and 6 months after explantation.

  0-365 days

Study Arms (1)

Human islets in Beta-Air device

EXPERIMENTAL

Device: Beta-Air device for encapsulation of transplanted human islets

Interventions

Beta-Air device for encapsulation of transplanted human islets DEVICE

Human islets in Beta-Air device

Eligibility Criteria

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

You may qualify if:

• Informed consent obtained before any investigation-related activities. Investigation-related activities are any procedure that would not have been performed during normal management of the subject.
• Diagnosis of type 1 diabetes mellitus for \> 5 years
• Men or women \> 18 years of age at the time of enrolment
• 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.

You may not qualify if:

• Body mass index (BMI) \> 30 kg/m²
• Insulin requirement of \> 1.0 Units/kg/day
• HbA1c \> 10 % (DCCT)
• Random C-peptide \> 0.003 nmol/l
• Known untreated active proliferative diabetic retinopathy changes or increasing macular oedema
• Renal failure (Glomerular Filtration Rate \<60 ml/min)
• 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).
• Active infection including hepatitis B, hepatitis C, HIV, Tbc
• Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
• Known active alcohol or drug abuse.
• 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.
• Severe co-existing cardiac disease, characterized by any of these conditions:
• Recent myocardial infarction (within past 36 weeks)
• Evidence of ischemia on functional cardiac exam within the last year
• Left ventricular ejection fraction \< 30 %

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Beta-O2 Technologies Ltd.: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, SE-75123, Sweden

Location

Related Publications (1)

• 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.

  PMID: 29288549 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

SE (1)