Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2011-05-31
2018-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators hypothesize that functional beta-cell mass will be more than 20% compared to healthy controls.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Patients with loss of long-term function after intraportal implantation
Transplantation of encapsulated beta cells.
Implantation of a therapeutical dose of encapsulated beta cells.
Group B
Patients that are candidates for islet cell transplantation
Transplantation of encapsulated beta cells.
Implantation of a therapeutical dose of encapsulated beta cells.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transplantation of encapsulated beta cells.
Implantation of a therapeutical dose of encapsulated beta cells.
Transplantation of encapsulated beta cells.
Implantation of a therapeutical dose of encapsulated beta cells.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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
Exclusion Criteria
* Smoker
* EBV antibody negativity
* HIV 1 \& 2 antibody positivity
* CMV IgM positivity
* Hepatitis B infection
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitair Ziekenhuis Brussel
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
AZ-VUB
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bart Keymeulen
MD. PhD.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bart Keymeulen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UZ Brussel
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bart Keymeulen, MD PhD
Role: primary
Pieter, Gillard
Role: primary
Da Hae Lee, MD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BK_TX_07
Identifier Type: -
Identifier Source: org_study_id