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Type 1 DiabetesPhase 2NCT01736228

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

A Phase 2 study testing DIABECELL in people with Type 1 Diabetes, run by Living Cell Technologies at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
DIABECELL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteArgentina
Study dates
Nov 2012to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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
  • Previous cerebrovascular disease manifesting as transient ischaemic attacks (TIAs) or stroke
  • Peripheral vascular disease with previous amputation
  • History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and/or chronic atrial fibrillation
  • Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalisation for decompensation; a requirement for mechanical ventilation at any stage; or long-term treatment with oral corticosteroids
  • Liver disease with abnormal liver function tests defined as serum bilirubin ≥20 µmol/L, and/or ALT ≥100 U/L, and/or GGT ≥100 U/L, and/or albumin <35 g/L
  • Haematological disorders, including haemoglobin ≤110 g/L or platelet count <80 x 109/L
  • Peptic ulcer disease and/or history of previous gastrointestinal bleeding
  • Malignancy other than basal cell carcinoma
  • History of epilepsy
  • Untreated hypothyroidism
  • Known adrenal insufficiency
  • History of drug, substance or alcohol addiction
  • Any factor detected from psychometric evaluation at Visit 2 pre-transplant during the screening period which may in the opinion of the Clinical Psychologist affect an individual's ability to fully participate in the study
  • Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, mental illness, or a history of non-adherence to appointments or treatments

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital Interzonal General de Agudos Eva Perón

    San Martín, Buenos Aires, 3200

Other trials in Argentina

About this study

Official title: A Phase IIb Open-label Investigation of the Safety and Efficacy of DIABECELL [Immunoprotected (Alginate-Encapsulated) Porcine Islets for Xenotransplantation] in Patients With Type 1 Diabetes Mellitus

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

Read the detailed description

Intraperitoneal islet transplantation has the potential to ameliorate type 1 diabetes mellitus and avert the long-term consequences of chronic diabetes which cannot be achieved by conventional insulin treatment.

As donor human islets are not available in sufficient numbers, porcine islets are the best alternative source as they are recognised as the most physiologically compatible xenogeneic insulin-producing cells. Although the use of pig-derived cells raises the risk of xenotic infections, this can be minimised by obtaining cells from designated pathogen-free (DPF) animals bred in isolation and monitored to be free of specified pathogens. The worldwide experience to date in more than 200 patients who have received transplants of pig tissue has not demonstrated evidence of transmitted xenotic infections.

As animal-derived tissues have to be protected from immune rejection when transplanted into humans, transplants are usually accompanied by immunosuppressive therapy. However, porcine islets are preferably transplanted without the use of immunosuppressive drugs which cause significant morbidity. To protect them from immune rejection, the islets can be encapsulated in alginate microcapsules which permit the inward passage of nutrients and glucose and the outward passage of insulin. Alginate-encapsulated porcine islets transplanted without immunosuppressive drugs have survived rejection for many months in animal studies.

DIABECELL comprises neonatal porcine islets encapsulated in alginate microcapsules. DIABECELL has been safely transplanted in healthy and diabetic mice, rats, rabbits, dogs and non-human primates. Following DIABECELL transplants, the requirement for daily insulin was significantly reduced in diabetic rats and non-human primates.

The optimal dose and frequency of transplantation of the current DIABECELL preparation for the treatment of type 1 diabetes in humans can only be determined in clinical trials. The intention of this phase IIb clinical trial is to obtain at least 52 weeks safety and preliminary efficacy data in type 1 diabetic patients following transplantation of two effective doses of DIABECELL into the peritoneal cavity.

Conditions
Type 1 Diabetes
Being tested
DIABECELL
Keywords
xenotransplantation, type 1 diabetes, porcine islets
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DIABECELLDevice

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

Study groups in NCT01736228
Study groupRoleWhat they receive
DIABECELLExperimentaltwo transplants of 10,000 IEQ/kg DIABECELL (administered at least 12 weeks apart)- total of 20,000 IEQ/kg
Receives: Device: DIABECELL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    Measured: 52 weeks

Secondary outcomes (2)

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

    Measured: 52 weeks

  2. Improvement in the quality-of-life of xenotransplant recipients

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01736228
Sponsor's protocol ID
LCT/DIA-12
Status last verified
Oct 2013
First submitted
26 Nov 2012
Last updated
17 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DIABECELL in people with Type 1 Diabetes, run by Living Cell Technologies at 1 site in Argentina.

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 7 inclusion and 29 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: finished, as of the sponsor's last update on 17 Mar 2015. 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 Argentina. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

to establish the efficacy and safety of DIABECELL (time frame: 52 weeks). 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 NCT01736228.

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 17 Mar 2015.

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