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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

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ClinicalTrials.gov Identifier: NCT02064309
Recruitment Status : Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Beta-O2 Technologies Ltd.
Information provided by (Responsible Party):
Per-Ola Carlsson, Uppsala University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Long-standing Type 1 Diabetes Mellitus Device: Beta-Air device for encapsulation of transplanted human islets Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Human islets in Beta-Air device Device: Beta-Air device for encapsulation of transplanted human islets


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. 2. Incidence and severity of fibrosis surrounding the device during course of study. [ Time Frame: 0-365 days ]
  3. 3. Signs of immunization in transplanted patients. [ Time Frame: 0-365 days ]
  4. 4. Oxygenation of tissue in the device, as evaluated at 4, 12 and 26 weeks post-transplantation [ Time Frame: 0-180 days ]
  5. 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. 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. 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. 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 ]

Other Outcome Measures:
  1. 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 [ Time Frame: 0-26 weeks post-transplantation ]
  2. 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 [ Time Frame: 0-365 days ]
  3. 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. [ Time Frame: 0-365 days ]
  4. 4. Delta changes in P-fructosamine at 2, 4, 8, 12, 18 and 26 weeks post-transplantation when compared to before transplantation and 6 months after explantation. [ Time Frame: 0-365 days ]
  5. 5. Delta changes in glucose variability and hypo/hyper glycaemia duration derived from a continuous glucose monitoring system performed at 12 and 26 weeks post-transplantation when compared to before transplantation and 6 months after explantation. [ Time Frame: 0-365 days ]
  6. 6. Quality of Life in transplanted patients at 12 and 26 weeks post-transplantation when compared to before transplantation and 6 months after explantation. [ Time Frame: 0-365 days ]
  7. 7. Score in diabetes treatment satisfaction questionnaire in transplanted patients at 12 and 26 weeks post-transplantation when compared to before transplantation and 6 months after explantation. [ Time Frame: 0-365 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  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:

  1. Body mass index (BMI) > 30 kg/m²
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064309


Locations
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Sweden
Uppsala University Hospital
Uppsala, Sweden, SE-75123
Sponsors and Collaborators
Uppsala University Hospital
Beta-O2 Technologies Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Per-Ola Carlsson, Professor, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT02064309     History of Changes
Other Study ID Numbers: AS Dnr2013/299
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Pancrelipase
Gastrointestinal Agents