Diabetes Mellitus, Type 1Phase 1/2NCT00798785
Long-term Function of Beta Cell Allografts in Non-uremic Type 1 Diabetic Patients
A Phase 1/2 study testing ATG-MMF-TAC, ATG-Rituximab-MMF-TAC and ATG-basilixumab-MMF-TAC in people with Diabetes Mellitus, Type 1, run by Universitair Ziekenhuis Brussel at 4 sites in Belgium.
Trial summary
The present proof of concept study addresses the following specific aims: The general objectives of this work are: 1. To increase and maintain the functional beta-cell mass after islet transplantation under a condition of low-dose tacrolimus 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- ATG-MMF-TAC, ATG-Rituximab-MMF-TAC and ATG-basilixumab-MMF-TAC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesBelgium
- Study dates
- Oct 2006to Dec 2014
- Phase
- Phase 1/2
- 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
- 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
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- Patients should have at least one of the following chronic complications of diabetes:
- Plasma creatinine <2 mg/dl and albuminuria 30-1000 mg/ 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
- Smoker
- EBV antibody negativity
- HIV 1 \& 2 antibody positivity
- CMV IgM positivity
- Plasma creatinine ≥ 2 mg/dl and/or albuminuria ≥1000 mg/24 hrs
- History of thrombosis or pulmonary embolism
Show all 21Show fewer
- History of malignancy, tuberculosis or chronic viral hepatitis
- History of any other serious illness which could be relevant for the protocol
- Presence of HLA antibodies
- Blood donation within one month prior to screening or during the study
- Symptoms and/or signs of infection, particularly (present or past) endocarditis, osteomyelitis, past tuberculosis with requirement for therapy
- 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
- Pregnancy or use of inadequate contraception by female patients of childbearing potential
- Use of illicit drugs or overconsumption of alcohol (> 3 beers/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 psychiatric disorders
- Having received antidepressant medications during the last 6 months
- Having participated the last 12 months or participating in another clinical study
Trial locations and contacts
4 sites in 1 country.
Bart Keymeulen, MD Phd contact
Belgium4 sites, 4 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Antwerp
Christophe De Block, MD,PhD
Christophe de Block, MD,PhD
- Recruiting
University Hospital Brussels
Brussels, 1090
Bart Keymeulen, MD PhD, +32 2 477 61 11, bart.keymeulen@uzbrussel.be
Bart Keymeulen, MD PhD
- Recruiting
Hopital Erasme
Brussels
Laurent Crenier, MD
Laurent Crenier, MD
- Recruiting
University Hospital Leuven
Leuven, 3000
Pieter Gillard, MD PhD, +32 16 34 85 54, pieter.gillard@uz.kuleuven.ac.be
Da Hae Lee, MD, +32 16 34 23 98, dahae.lee@uzleuven.be
About this study
The present proof of concept study addresses the following specific aims:
The general objectives of this work are:
- To increase and maintain the functional beta-cell mass after islet transplantation under a condition of low-dose tacrolimus
- To co-investigate the potential of alternative sites for encapsulated beta-cells
Read the detailed description
- Aim 1: To increase functional beta cell mass by adding rituximab at first implantation
- Aim 2: To increase functional beta cell mass by adding basilixumab at second implantation
- Aim 3: To assess the influence of down-tapering the tacrolimus dose during posttransplant years 2-5 on these data, on metabolic control, on the prevalence of hypoglycemia and on safety parameters.
- Aim 4: To investigate the potential of the peritoneum and omentum as an alternative site for encapsulated beta-cells.
- Aim 5: To investigate the potential of the brachioradial muscle as an alternative site for encapsulated beta-cells.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- ATG-MMF-TAC, ATG-Rituximab-MMF-TAC, ATG-basilixumab-MMF-TAC, omentum
- Keywords
- diabetes mellitus type 1, pancreatic beta cell, transplantation
- 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.
ATG-MMF-TACDrug
ATG-fresenium for max 6 consecutive days depending on CD3 count, starting the day before transplantation.
Tacrolimus levels for 2 years between 8-10 ng/ml.
At year 2: randomization:
group A: till 48 months: tacrolimus levels 8-10 ng/ml 48-60 months: tacrolimus levels 6-8 ng/ml group B: 24-36 months: 6-8 ng/ml 36-60 months: 4-6 ng/ml A subgroup of these patients will receive a sub clinical implant subcutaneous (total n=5) at the time of the first clinical implant in the liver.
ATG-Rituximab-MMF-TACDrug
ATG-fresenium for max 6 consecutive days depending on CD3 count, starting the day before transplantation.
Rituximab: the day before transplantation, day 5; 12 and 19 after implantation. Tacrolimus levels for 2 years between 8-10 ng/ml.
At year 2: randomization:
group A: till 48 months: tacrolimus levels 8-10 ng/ml 48-60 months: tacrolimus levels 6-8 ng/ml group B: 24-36 months: 6-8 ng/ml 36-60 months: 4-6 ng/ml A subgroup of these patients will receive a sub clinical implant, subcutaneous at the time of the first clinical implant in the liver.
ATG-basilixumab-MMF-TACDrug
First transplantation:
ATG-fresenium for max 6 consecutive days depending on CD3 count, starting the day before transplantation.
Second transplantation:
Basilixumab:
the day before the second transplantation followed by 4days after transplantation.
Tacrolimus levels for 2 years between 8-10 ng/ml.
At year 2: randomization:
group A: till 48 months: tacrolimus levels 8-10 ng/ml 48-60 months: tacrolimus levels 6-8 ng/ml group B: 24-36 months: 6-8 ng/ml 36-60 months: 4-6 ng/ml A subgroup of these patients will receive a sub clinical implant, subcutaneous at the time of the first clinical implant in the liver.
omentumProcedure or surgery
Two clinical implants: first in omentum followed by a clinical implant in the liver:
In a group of 10 patients, a clinical implant in the omentum will be implanted. If random C-peptide levels >= 0.5 ng/ml are measured at 2 months post-transplantation, a second omental implant will be done. If no clinical relevant beta cell graft function is measured, two intraportal implants will be given as a compassionate use procedure. An interim analysis after 5 patients has to shown clinical relevant function at month 2 in 3 out of 5 patients before the subsequent 5 patients can be transplanted in the omentum.
| Study group | Role | What they receive |
|---|---|---|
| group I ATG-MMF-TAC | Experimental | Two clinical implants in the liver:
First implant: ATG-fresenium Maintained immunosuppression: MMF-TAC n=30 Receives: Drug: ATG-MMF-TAC |
| group II ATG-Rituximab-MMF-TAC | Experimental | Two clinical implants in the liver:
First Implant: ATG fresenium + Rituximab Maintained immunosuppression: MMF-TAC n=5 Receives: Drug: ATG-Rituximab-MMF-TAC |
| group III ATG-Basilixumab-MMF-TAC | Experimental | Two clinical implants in the liver:
First implant: ATG-fresenium Second implant: basilixumab Maintained immunosuppression: MMF-TAC n=5 Receives: Drug: ATG-basilixumab-MMF-TAC |
| group IV omentum | Experimental | Two clinical implants: first in the omentum followed by a clinical implant in the liver:
First implant: ATG-fresenium Maintained immunosuppression: MMF-TAC n=10 Receives: Procedure: omentum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically relevant beta cell graft function
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart Keymeulen, Universitair Ziekenhuis Brussel
- Investigators
- Bart Keymeulen, MD PhD, Principal investigator, University Hospital Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798785
- Sponsor's protocol ID
- BK_TX_06
- Status last verified
- Dec 2013
- First submitted
- 25 Nov 2008
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Keymeulen B, Gillard P, Mathieu C, Movahedi B, Maleux G, Delvaux G, Ysebaert D, Roep B, Vandemeulebroucke E, Marichal M, In 't Veld P, Bogdani M, Hendrieckx C, Gorus F, Ling Z, van Rood J, Pipeleers D. Correlation between beta cell mass and glycemic control in type 1 diabetic recipients of islet cell graft. Proc Natl Acad Sci U S A. 2006 Nov 14;103(46):17444-9. doi: 10.1073/pnas.0608141103. Epub 2006 Nov 7.
PubMed 17090674Movahedi B, Keymeulen B, Lauwers MH, Goes E, Cools N, Delvaux G. Laparoscopic approach for human islet transplantation into a defined liver segment in type-1 diabetic patients. Transpl Int. 2003 Mar;16(3):186-90. doi: 10.1007/s00147-002-0517-7. Epub 2003 Feb 15.
PubMed 12664214Maleux G, Gillard P, Keymeulen B, Pipeleers D, Ling Z, Heye S, Thijs M, Mathieu C, Marchal G. Feasibility, safety, and efficacy of percutaneous transhepatic injection of beta-cell grafts. J Vasc Interv Radiol. 2005 Dec;16(12):1693-7. doi: 10.1097/01.RVI.0000182506.88739.39.
PubMed 16371537Lee D, Gillard P, Hilbrands R, Ling Z, Van de Velde U, Jacobs-Tulleneers-Thevissen D, Maleux G, Lapauw B, Crenier L, De Block C, Mathieu C, Pipeleers D, Keymeulen B. Use of Culture to Reach Metabolically Adequate Beta-cell Dose by Combining Donor Islet Cell Isolates for Transplantation in Type 1 Diabetes Patients. Transplantation. 2020 Oct;104(10):e295-e302. doi: 10.1097/TP.0000000000003321.
PubMed 32433237Balke EM, Demeester S, Lee D, Gillard P, Hilbrands R, Van de Velde U, Van der Auwera BJ, Ling Z, Roep BO, Pipeleers DG, Keymeulen B, Gorus FK. SLC30A8 polymorphism and BMI complement HLA-A*24 as risk factors for poor graft function in islet allograft recipients. Diabetologia. 2018 Jul;61(7):1623-1632. doi: 10.1007/s00125-018-4609-z. Epub 2018 Apr 20.
PubMed 29679103Lee D, Keymeulen B, Hilbrands R, Ling Z, Van de Velde U, Jacobs-Tulleneers-Thevissen D, Maleux G, Lapauw B, Crenier L, De Block C, Mathieu C, Pipeleers D, Gillard P. Age and Early Graft Function Relate With Risk-Benefit Ratio of Allogenic Islet Transplantation Under Antithymocyte Globulin-Mycophenolate Mofetil-Tacrolimus Immune Suppression. Transplantation. 2017 Sep;101(9):2218-2227. doi: 10.1097/TP.0000000000001543.
PubMed 27779572
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Function of Beta Cell Allografts in Non-uremic Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00798785
- Acronym / sponsor ID
- BK_TX_06
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- diabetes mellitus type 1, pancreatic beta cell, transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present proof of concept study addresses the following specific aims:
The general objectives of this work are:
- To increase and maintain the functional beta-cell mass after islet transplantation under a condition of low-dose tacrolimus
- To co-investigate the potential of alternative sites for encapsulated beta-cells
Detailed description
- Aim 1: To increase functional beta cell mass by adding rituximab at first implantation
- Aim 2: To increase functional beta cell mass by adding basilixumab at second implantation
- Aim 3: To assess the influence of down-tapering the tacrolimus dose during posttransplant years 2-5 on these data, on metabolic control, on the prevalence of hypoglycemia and on safety parameters.
- Aim 4: To investigate the potential of the peritoneum and omentum as an alternative site for encapsulated beta-cells.
- Aim 5: To investigate the potential of the brachioradial muscle as an alternative site for encapsulated beta-cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group I ATG-MMF-TAC | Experimental | Drug: ATG-MMF-TACTwo clinical implants in the liver: First implant: ATG-fresenium Maintained immunosuppression: MMF-TAC n=30 |
| group II ATG-Rituximab-MMF-TAC | Experimental | Drug: ATG-Rituximab-MMF-TACTwo clinical implants in the liver: First Implant: ATG fresenium + Rituximab Maintained immunosuppression: MMF-TAC n=5 |
| group III ATG-Basilixumab-MMF-TAC | Experimental | Drug: ATG-basilixumab-MMF-TACTwo clinical implants in the liver: First implant: ATG-fresenium Second implant: basilixumab Maintained immunosuppression: MMF-TAC n=5 |
| group IV omentum | Experimental | Procedure: omentumTwo clinical implants: first in the omentum followed by a clinical implant in the liver: First implant: ATG-fresenium Maintained immunosuppression: MMF-TAC n=10 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (21 listed)
- Smoker
- EBV antibody negativity
- HIV 1 \& 2 antibody positivity
- CMV IgM positivity
- Plasma creatinine ≥ 2 mg/dl and/or albuminuria ≥1000 mg/24 hrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-MMF-TACATG-fresenium for max 6 consecutive days depending on CD3 count, starting the day before transplantation. Tacrolimus levels for 2 years between 8-10 ng/ml. At year 2: randomization: group A: till 48 months: tacrolimus levels 8-10 ng/ml 48-60 months: tacrolimus levels 6-8 ng/ml group B: 24-36 months: 6-8 ng/ml 36-60 months: 4-6 ng/ml A subgroup of these patients will receive a sub clinical implant subcutaneous (total n=5) at the time of the first clinical implant in the liver. | Drug | group I ATG-MMF-TAC |
| ATG-Rituximab-MMF-TACATG-fresenium for max 6 consecutive days depending on CD3 count, starting the day before transplantation. Rituximab: the day before transplantation, day 5; 12 and 19 after implantation. Tacrolimus levels for 2 years between 8-10 ng/ml. At year 2: randomization: group A: till 48 months: tacrolimus levels 8-10 ng/ml 48-60 months: tacrolimus levels 6-8 ng/ml group B: 24-36 months: 6-8 ng/ml 36-60 months: 4-6 ng/ml A subgroup of these patients will receive a sub clinical implant, subcutaneous at the time of the first clinical implant in the liver. | Drug | group II ATG-Rituximab-MMF-TAC |
| ATG-basilixumab-MMF-TACFirst transplantation: ATG-fresenium for max 6 consecutive days depending on CD3 count, starting the day before transplantation. Second transplantation: Basilixumab: the day before the second transplantation followed by 4days after transplantation. Tacrolimus levels for 2 years between 8-10 ng/ml. At year 2: randomization: group A: till 48 months: tacrolimus levels 8-10 ng/ml 48-60 months: tacrolimus levels 6-8 ng/ml group B: 24-36 months: 6-8 ng/ml 36-60 months: 4-6 ng/ml A subgroup of these patients will receive a sub clinical implant, subcutaneous at the time of the first clinical implant in the liver. | Drug | group III ATG-Basilixumab-MMF-TAC |
| omentumTwo clinical implants: first in omentum followed by a clinical implant in the liver: In a group of 10 patients, a clinical implant in the omentum will be implanted. If random C-peptide levels >= 0.5 ng/ml are measured at 2 months post-transplantation, a second omental implant will be done. If no clinical relevant beta cell graft function is measured, two intraportal implants will be given as a compassionate use procedure. An interim analysis after 5 patients has to shown clinical relevant function at month 2 in 3 out of 5 patients before the subsequent 5 patients can be transplanted in the omentum. | Procedure or surgery | group IV omentum |
Primary outcome
Evidence of clinically relevant beta cell graft function
Time frame: up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Background: PubMed 17090674Keymeulen B, Gillard P, Mathieu C, Movahedi B, Maleux G, Delvaux G, Ysebaert D, Roep B, Vandemeulebroucke E, Marichal M, In 't Veld P, Bogdani M, Hendrieckx C, Gorus F, Ling Z, van Rood J, Pipeleers D. Correlation between beta cell mass and glycemic control in type 1 diabetic recipients of islet cell graft. Proc Natl Acad Sci U S A. 2006 Nov 14;103(46):17444-9. doi: 10.1073/pnas.0608141103. Epub 2006 Nov 7.
- Background: PubMed 12664214Movahedi B, Keymeulen B, Lauwers MH, Goes E, Cools N, Delvaux G. Laparoscopic approach for human islet transplantation into a defined liver segment in type-1 diabetic patients. Transpl Int. 2003 Mar;16(3):186-90. doi: 10.1007/s00147-002-0517-7. Epub 2003 Feb 15.
- Background: PubMed 16371537Maleux G, Gillard P, Keymeulen B, Pipeleers D, Ling Z, Heye S, Thijs M, Mathieu C, Marchal G. Feasibility, safety, and efficacy of percutaneous transhepatic injection of beta-cell grafts. J Vasc Interv Radiol. 2005 Dec;16(12):1693-7. doi: 10.1097/01.RVI.0000182506.88739.39.
- Derived from this study: PubMed 32433237Lee D, Gillard P, Hilbrands R, Ling Z, Van de Velde U, Jacobs-Tulleneers-Thevissen D, Maleux G, Lapauw B, Crenier L, De Block C, Mathieu C, Pipeleers D, Keymeulen B. Use of Culture to Reach Metabolically Adequate Beta-cell Dose by Combining Donor Islet Cell Isolates for Transplantation in Type 1 Diabetes Patients. Transplantation. 2020 Oct;104(10):e295-e302. doi: 10.1097/TP.0000000000003321.
- Derived from this study: PubMed 29679103Balke EM, Demeester S, Lee D, Gillard P, Hilbrands R, Van de Velde U, Van der Auwera BJ, Ling Z, Roep BO, Pipeleers DG, Keymeulen B, Gorus FK. SLC30A8 polymorphism and BMI complement HLA-A*24 as risk factors for poor graft function in islet allograft recipients. Diabetologia. 2018 Jul;61(7):1623-1632. doi: 10.1007/s00125-018-4609-z. Epub 2018 Apr 20.
- Derived from this study: PubMed 27779572Lee D, Keymeulen B, Hilbrands R, Ling Z, Van de Velde U, Jacobs-Tulleneers-Thevissen D, Maleux G, Lapauw B, Crenier L, De Block C, Mathieu C, Pipeleers D, Gillard P. Age and Early Graft Function Relate With Risk-Benefit Ratio of Allogenic Islet Transplantation Under Antithymocyte Globulin-Mycophenolate Mofetil-Tacrolimus Immune Suppression. Transplantation. 2017 Sep;101(9):2218-2227. doi: 10.1097/TP.0000000000001543.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Keymeulen, MD Phd contact
Bart Keymeulen, MD PhD principal investigator
University Hospital Brussel
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATG-MMF-TAC, ATG-Rituximab-MMF-TAC and ATG-basilixumab-MMF-TAC in people with Diabetes Mellitus, Type 1, run by Universitair Ziekenhuis Brussel at 4 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 11 inclusion and 21 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 4 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evidence of clinically relevant beta cell graft function (time frame: up to 60 months). 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 NCT00798785, 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.