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Type 1 DiabetesPhase 2NCT01379729

Bet Cell Therapy in Diabetes Type 1

A Phase 2 study testing Transplantation of encapsulated beta cells. in people with Type 1 Diabetes, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT. Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during hyperglycemic clamp at 180 mg/dl. 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?
Transplantation of encapsulated beta cells.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesBelgium
Study dates
May 2011to May 2018
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

  • Group A:
  • Patients with loss of long-term function after intraportal implantation (- Patients with type 1 insulin-dependent diabetes who received two intraportal implantations > 12 months ago.
  • Random C-peptide between 0.09 and 0.5 ng/dl (glycemia between 100 and 200 mg/dl)
  • Cooperative and reliable patient giving informed consent by signature
  • Group B:
  • Patients that are candidates for islet cell transplantation - age 18-65 years, male or female, Caucasian or not; only subjects < 50 yrs will be allocated to the rituximab treatment arm
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  • body weight < 100 kg; patients with a bodyweight of < 80kg, will receive priority
  • patients with a BMI ≤ 27 kg/m2 will receive priority
  • Type 1 insulin-dependent diabetes
  • C-peptide < 0.07 nmol/l (< 0.2 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl)
  • Intensive insulin therapy for more than two years, patients with insulin pump during at least 2 months before inclusion will receive priority
  • Patients should have at least one of the following chronic complications of diabetes:
  • albuminuria 30-1000mg/ 24hrs on 3 separate determinations (>1 month) outside an episode of illness, despite intake of ACE inhibitors; mean systolic blood pressure should be under 130 mmHg and mean diastolic blood pressure under 85 mmHg, when measured at home with ambulatory BP monitoring
  • moderate or severe non-proliferative or proliferative retinopathy
  • hypoglycemic unawareness
  • Cooperative and reliable patient giving informed consent by signature

Who cannot join

  • Women of reproductive age
  • Smoker
  • EBV antibody negativity
  • HIV 1 \& 2 antibody positivity
  • CMV IgM positivity
  • Hepatitis B infection
Show all 23Show fewer
  • GFR < 45 ml/min/1.72 m2
  • Albuminuria ≥ 1000 mg/24 hrs
  • History of thrombosis or pulmonary embolism
  • History of malignancy, tuberculosis or chronic viral hepatitis
  • History of any other serious illness which could be relevant for the protocol
  • Presence of clinical significant HLA antibodies
  • Blood donation within one month prior to screening
  • Symptoms and/or signs of infection, particularly (present or past) endocarditis, osteomyelitis
  • Any history of hepatic or neoplastic disease
  • Any history of renal disease (except diabetes)
  • Abnormal liver function tests and/or NMR of liver
  • Hemoglobinopathy
  • History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient
  • Use of illicit drugs or overconsumption of alcohol (> 3 IU/day) or history of drug or alcohol abuse
  • Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of a psychiatric disorder that may be exacerbated by the transplantation procedure or interfere with compliance during follow-up
  • Having received antidepressant medications during the last 6 months
  • Participating in another pharmacological study

Trial locations and contacts

2 sites in 1 country.

Bart Keymeulen, MD PhD contact

+32 2 477 61 11

bart.keymeulen@uzbrussel.be

Robert Hilbrands, MD PhD contact

+32 2 476 37 34

Robert.Hilbrands@uzbrussel.be

Belgium2 sites, 2 recruiting

  • UZ Brussel

    Brussels, 1090

    Bart Keymeulen, MD PhD, +32 2 477 61 11, bart.keymeulen@uzbrussel.be

    Bart Keymeulen, MD PhD

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Pieter, Gillard, pieter.gillard@uzleuven.be

    Da Hae Lee, MD, +32 16 34 23 98, dahae.lee@uzleuven.be

    Recruiting

Other trials in Belgium

About this study

Official title: Functional Survival of Beta Cell Allografts After Transplantation in the Peritoneal Cavity of Non-uremic Type 1 Diabetic Patients

Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT. Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during hyperglycemic clamp at 180 mg/dl.

The investigators hypothesize that functional beta-cell mass will be more than 20% compared to healthy controls.

Read more

Secondary outcome measurements:

Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.

The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against base-line (base-line = before first intraperitoneal transplantation):

  • metabolic control
  • safety parameters
  • episodes of hypoglycemia
  • islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and alloantigens using pre-transplant measurements as base-line The investigators hypothesize that metabolic control and prevalence of hypoglycemia, will be significantly improved till PT month 12.

Histopathology of a biopsy specimen of the human intraperitoneal beta cell implant, at time of the second implant. Comparison with composition of graft, identification of microenvironment of host origin and correlation with functional assessment will be performed.

Read the detailed description

In recipients with loss of long-term function after intraportal implantation (Group A)

  1. To implant an alginate embedded human beta cell graft in a "therapeutic" dose in the intraperitoneal cavity of type 1 diabetic patients under immunosuppression with tacrolimus/MMF.
  2. To obtain histopathology of a biopsy specimen of the intraperitoneal human beta cell implant.
  3. To assess the safety profile, metabolic and immune effects of alginate embedded implants in the intraperitoneal cavity. In patients that are candidates for islet cell transplantation (Group B)
  4. To implant an alginate embedded human beta cell graft in a "therapeutic" dose in intraperitoneal cavity of type 1 diabetic patients under immunosuppression with tacrolimus/MMF.
  5. To obtain histopathology of a biopsy specimen of the intraperitoneal human beta cell implant
  6. To assess the safety profile, metabolic and immune effects of alginate embedded implants in the intraperitoneal cavity.
Conditions
Type 1 Diabetes
Being tested
Transplantation of encapsulated beta cells.
Keywords
Type 1 Diabetes, Transplantation, Beta Cells, Encapsulation
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.

  • Transplantation of encapsulated beta cells.Other

    Also called encapsulated beta cells

    Implantation of a therapeutical dose of encapsulated beta cells.

  • Transplantation of encapsulated beta cells.Other

    Also called encapsulated beta cells

    Implantation of a therapeutical dose of encapsulated beta cells.

Study groups in NCT01379729
Study groupRoleWhat they receive
Group AActive comparatorPatients with loss of long-term function after intraportal implantation
Receives: Other: Transplantation of encapsulated beta cells.
Group BActive comparatorPatients that are candidates for islet cell transplantation
Receives: Other: Transplantation of encapsulated beta cells.

What is being measured

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

  1. Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT. Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during hyperglycemic clamp at 180 mg/dl.

    Measured: 6 months PT.

Secondary outcomes (3)

  1. Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.

    Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.

    The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against base-line (base-line = before first intraperitoneal transplantation):

    • metabolic control
    • safety parameters
    • episodes of hypoglycemia
    • islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and alloantigens using pre-transplant measurements as base-line

    Measured: 60 months

  2. Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.

    Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.

    Measured: 60 months

  3. Changes from Baseline

    The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against base-line (base-line = before first intraperitoneal transplantation):

    • metabolic control
    • safety parameters
    • episodes of hypoglycemia
    • islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and alloantigens using pre-transplant measurements as base-line

    Measured: 60 months

Timeline

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

  1. First posted23 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2013 (estimated)
  4. Study completionMay 2018 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01379729
Sponsor's protocol ID
BK_TX_07
Status last verified
Dec 2013
First submitted
2 May 2011
Last updated
30 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Gillard P, Keymeulen B, Mathieu C. Beta-cell transplantation in type 1 diabetic patients: a work in progress to cure. Verh K Acad Geneeskd Belg. 2010;72(1-2):71-98.

    PubMed 20726441

  • Hilbrands R, Huurman VA, Gillard P, Velthuis JH, De Waele M, Mathieu C, Kaufman L, Pipeleers-Marichal M, Ling Z, Movahedi B, Jacobs-Tulleneers-Thevissen D, Monbaliu D, Ysebaert D, Gorus FK, Roep BO, Pipeleers DG, Keymeulen B. Differences in baseline lymphocyte counts and autoreactivity are associated with differences in outcome of islet cell transplantation in type 1 diabetic patients. Diabetes. 2009 Oct;58(10):2267-76. doi: 10.2337/db09-0160. Epub 2009 Jul 14.

    PubMed 19602536

  • Gillard P, Vandemeulebroucke E, Keymeulen B, Pirenne J, Maes B, De Pauw P, Vanrenterghem Y, Pipeleers D, Mathieu C. Functional beta-cell mass and insulin sensitivity is decreased in insulin-independent pancreas-kidney recipients. Transplantation. 2009 Feb 15;87(3):402-7. doi: 10.1097/TP.0b013e3181928a1c.

    PubMed 19202446

  • Pipeleers D, Chintinne M, Denys B, Martens G, Keymeulen B, Gorus F. Restoring a functional beta-cell mass in diabetes. Diabetes Obes Metab. 2008 Nov;10 Suppl 4:54-62. doi: 10.1111/j.1463-1326.2008.00941.x.

    PubMed 18834433

  • Keymeulen B. Therapies aimed at preservation or restoration of beta cell function in type 1 diabetes. Verh K Acad Geneeskd Belg. 2008;70(2):85-103.

    PubMed 18630722

  • Jacobs-Tulleneers-Thevissen D, Chintinne M, Ling Z, Gillard P, Schoonjans L, Delvaux G, Strand BL, Gorus F, Keymeulen B, Pipeleers D; Beta Cell Therapy Consortium EU-FP7. Sustained function of alginate-encapsulated human islet cell implants in the peritoneal cavity of mice leading to a pilot study in a type 1 diabetic patient. Diabetologia. 2013 Jul;56(7):1605-14. doi: 10.1007/s00125-013-2906-0. Epub 2013 Apr 26.

    PubMed 23620058

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transplantation of encapsulated beta cells. in people with Type 1 Diabetes, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.

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 16 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bart Keymeulen, MD PhD (+32 2 477 61 11, bart.keymeulen@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT. Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during hyperglycemic clamp at 180 mg/dl. (time frame: 6 months PT.). 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 NCT01379729, which also lists 6 linked publications.

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 30 Dec 2013.

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