Open-label Investigation of the Safety and Efficacy of DIABECELL in Patients With Type 1 Diabetes Mellitus

NCT01736228 | Completed Phase 2 DMC

• 1 other identifier: LCT/DIA-12
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish the efficacy and safety of xenotransplantation of DIABECELL \[immunoprotected (alginate-encapsulated) porcine islets\] in patients with established type 1 diabetes mellitus

Conditions

Type 1 Diabetes

Keywords

xenotransplantation; type 1 diabetes; porcine islets

Outcome Measures

Primary Outcomes (1)

• to establish the efficacy and safety of DIABECELL

  1. Restoration of sustained euglycaemia, in particular avoidance of severe hypoglycaemia, with a reduction in unaware hypoglycaemic events, without an increase in insulin dose 2. Safety of xenotransplantation of DIABECELL \[immunoprotected (alginate-encapsulated) porcine islets\]

  52 weeks

Secondary Outcomes (2)

• Porcine β-cell function as demonstrated by measurement of porcine pro-insulin in xenotransplant recipients

  52 weeks

• Improvement in the quality-of-life of xenotransplant recipients

  52 weeks

Study Arms (1)

DIABECELL

EXPERIMENTAL

two transplants of 10,000 IEQ/kg DIABECELL (administered at least 12 weeks apart)- total of 20,000 IEQ/kg

Device: DIABECELL

Interventions

DIABECELL DEVICE

two transplants of 10,000 IEQ/kg DIABECELL (administered at least 12 weeks apart)- total of 20,000 IEQ/kg

DIABECELL

Eligibility Criteria

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

You may qualify if:

• Adults (males or females) in the age range 18 to 65 years
• Diagnosis of type 1 diabetes mellitus (minimum duration of 5 years) in accordance with the American Diabetes Association's criteria. Patients should have been treated continuously with insulin since diagnosis (Expert Committee on the Diagnosis and Classification of Diabetes Mellitus 2002)
• Patients with established brittle type I diabetes mellitus with a well-documented chronic history of metabolic instability who cannot achieve acceptable metabolic control (which may include treatment with the use of a continuous insulin infusion pump) without experiencing multiple episodes of hypoglycaemia, often with unawareness
• Patients with an HbA1C ≤12% prior to receiving their first xenotransplant
• Plasma C-peptide \<0.3 ng/mL following a glucagon stimulation test (Scheen et al. 1996)
• If female, no childbearing capability (those who are more than two years postmenopausal or have undergone voluntary sterilisation can be considered for enrolment) or if childbearing potential, agree to the insertion of an intrauterine device (IUD) for the duration of the study
• Provision of written informed consent. Patients will be required to agree to comply with all tests and visits specified in the protocol, and they (and their partners/close contacts) will also be required to consent to long-term microbiological monitoring, which is an integral part of the study

You may not qualify if:

• Type 2 diabetes, defined as age of onset \>30 years and/or a history of treatment with oral hypoglycaemic medications and/or insulin resistance (defined as an insulin dose requirement ≥1.2 U/kg/day)
• An HbA1C \>12% prior to receipt of the first xenotransplant Body mass index (BMI) ≥28 kg/m2
• Active infection, with plasma C-reactive protein ≥10 mg/L at baseline
• Previous receipt of an organ, skin graft, or other tissue transplant from a human or animal donor
• Treatment with immunosuppressive medications for another medical condition
• Previous history of peritoneal disease or abnormal findings at baseline laparoscopy
• Previous abdominal surgery, excluding uncomplicated appendectomy, cholecystectomy or caesarean section
• History of pelvic inflammatory disease or endometriosis
• Inability to tolerate oral medications or a history of significant malabsorption
• HIV antibody and/or risk factors for HIV infection
• Positive hepatitis C antibody, positive hepatitis B surface antigen and hepatitis B core antibody
• Kidney disease, defined as serum creatinine \>130 μmol/L in men and \>110 μmol/L in women and/or urinary albumin \>500 mg/L and/or haematuria and/or active urinary sediment or casts
• Diabetes microvascular complications defined as untreated, potentially vision-threatening proliferative or pre-proliferative retinopathy or maculopathy; painful peripheral neuropathy; autonomic neuropathy manifesting as postural hypotension; gastroparesis or diabetic enteropathy
• Serious comorbid conditions that are likely to affect participation in the study, including:
• Previous coronary heart disease manifesting as non-ST elevation myocardial infarction (NSTEMI), Q-wave infarction or unstable angina; coronary artery bypass graft (CABG); or percutaneous angioplasty

Sponsors & Collaborators

• Living Cell Technologies: lead

Study Sites (1)

Hospital Interzonal General de Agudos Eva Perón

San Martín, Buenos Aires, 3200, Argentina

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Adrián Abalovich

  Eva Perón Hospital, San Martín,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2013-10

Locations

AR (1)