Long-standing Type 1 Diabetes MellitusPhase 1/2NCT02064309
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
A Phase 1/2 study testing Beta-Air device for encapsulation of transplanted human islets in people with Long-standing Type 1 Diabetes Mellitus, run by Uppsala University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long-standing Type 1 Diabetes Mellitus
- What is being tested?
- Beta-Air device for encapsulation of transplanted human islets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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 %
- Cardiovascular conditions within 36 weeks prior to this trial:
- Decompensated heart failure New York Heart Association (NYHA) class III or IV ii. Unstable angina pectoris iii. Coronary arterial bypass graft iv. Coronary angioplasty
- Inadequately treated blood pressure elevation (systolic BP > 160 mmHg or diastolic blood pressure > 100 mmHg)
- Use of any medications to treat diabetes other than insulin within 4 weeks of enrolment
- Administration of live attenuated vaccine(s) within 8 weeks of enrolment
- Any previous organ transplant
- Treatment with any immunosuppressive drug
- Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial (e.g., systemic glucocorticoids)
- Known or suspected allergy of hypersensitivity to trial product(s) or related products
- The receipt of any investigational product within 30 days of screening for this trial
- Any scheduled transplant in addition to the islet transplantation
- Fulfillment of criteria for clinical pancreas or islet transplantation
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Beta-Air device for encapsulation of transplanted human islets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-Air device for encapsulation of transplanted human isletsDevice
| Study group | Role | What they receive |
|---|---|---|
| Human islets in Beta-Air device | Experimental | Not described Receives: Device: Beta-Air device for encapsulation of transplanted human islets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of device, as evaluated by incidence of adverse events or serious adverse events judged probable or highly probable related to the device
Measured: 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.
Measured: 0-365 days
2. Incidence and severity of fibrosis surrounding the device during course of study.
Measured: 0-365 days
3. Signs of immunization in transplanted patients.
Measured: 0-365 days
4. Oxygenation of tissue in the device, as evaluated at 4, 12 and 26 weeks post-transplantation
Measured: 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.
Measured: 0-180 days
6. Numbers of patients with peak c-peptide >0.20 nmol/l, in response to the mixed meal tolerance test at 12 and 26 weeks post-transplantation
Measured: 12 and 26 weeks post-transplantation
7. C-peptide area under the curve in response to the mixed meal tolerance test at 12 and 26 weeks post-transplantation.
Measured: 12 and 26 weeks post-transplantation
8. Number of patients with non-fasting c-peptide concentrations >0.003 nmol/l at 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 and 26 weeks post-transplantation; i.e. Kaplan-Meier analysis of survival time for islet grafts.
Measured: 0-26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long-standing Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beta-O2 Technologies Ltd.
- Responsible party
- Principal investigator, Per-Ola Carlsson, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064309
- Sponsor's protocol ID
- AS Dnr2013/299
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2014
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29288549
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02064309
- Acronym / sponsor ID
- AS Dnr2013/299
- Conditions
- Long-standing Type 1 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Beta-O2 Technologies Ltd.
- Study start
- Feb 2014 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human islets in Beta-Air device | Experimental | Device: Beta-Air device for encapsulation of transplanted human islets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-Air device for encapsulation of transplanted human islets | Device | Human islets in Beta-Air device |
Primary outcome
Safety of device, as evaluated by incidence of adverse events or serious adverse events judged probable or highly probable related to the device
Time frame: 0-365 days
8 secondary outcomes
1. Incidence of local or systemic inflammation or infection, incl. C-reactive protein rise, judged related to the device during course of study.
Time frame: 0-365 days
2. Incidence and severity of fibrosis surrounding the device during course of study.
Time frame: 0-365 days
3. Signs of immunization in transplanted patients.
Time frame: 0-365 days
4. Oxygenation of tissue in the device, as evaluated at 4, 12 and 26 weeks post-transplantation
Time frame: 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.
Time frame: 0-180 days
6. Numbers of patients with peak c-peptide >0.20 nmol/l, in response to the mixed meal tolerance test at 12 and 26 weeks post-transplantation
Time frame: 12 and 26 weeks post-transplantation
7. C-peptide area under the curve in response to the mixed meal tolerance test at 12 and 26 weeks post-transplantation.
Time frame: 12 and 26 weeks post-transplantation
8. Number of patients with non-fasting c-peptide concentrations >0.003 nmol/l at 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 and 26 weeks post-transplantation; i.e. Kaplan-Meier analysis of survival time for islet grafts.
Time frame: 0-26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 29288549Carlsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Beta-Air device for encapsulation of transplanted human islets in people with Long-standing Type 1 Diabetes Mellitus, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of device, as evaluated by incidence of adverse events or serious adverse events judged probable or highly probable related to the device (time frame: 0-365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.