Diabetes Mellitus, Type 1Phase 2NCT00021788
Islet Cell Transplantation Alone in Patients With Type I Diabetes Mellitus: Steroid-free Immunosuppression
A Phase 2 study testing islet cell transplantation in people with Diabetes Mellitus, Type 1, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The goal of islet cell transplantation in patients with Type 1 Diabetes Mellitus is to provide constant normal blood glucose levels. This may eliminate the need for insulin altogether or provide a significant reduction in the amount of insulin necessary to maintain constant normal blood glucose levels. 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?
- islet cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Dec 2001
- 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
- Candidates must be between the ages of 18 and 65
- Candidates must have had IDDM for at least 5 years and been under physician care for at least 6 months prior to enrollment in trial.
- Eligible candidates will have poorly controlled insulin-dependent diabetes mellitus (IDDM) and manifest signs and symptoms severe enough to be incapacitating. These symptoms can include episodes of hypoglycemic unawareness (failure to recognize blood glucose levels < 54 mg/dl) or episodes requiring the assistance of others.
- Candidates may have poor diabetes control despite intensive insulin therapy (HbA1c > 8.0%).
- Creatinine clearance should be > 60 ml/min)
- Body Mass Index should be less than 26
- Women of child-bearing age must have a negative pregnancy test and agree to follow effective contraceptive measures for the duration of the trial.
Who cannot join
- Previous or concurrent organ transplant
- Previous or concurrent malignancy
- Untreated proliferative diabetic retinopathy
- Unstable cardiovascular status, including positive stress echocardiography (if > age 35)
- Active infections, including x-ray evidence of pulmonary infection
- Peptic ulcer disease, gall stones, or portal hypertension
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- Abnormal liver function tests
- Presence of panel reactive antibodies > 20%
- Creatinine clearance < 60 ml/min
- HbA1c 12%
- Serological evidence of HIV, HbsAg, or HCV
- Anemia (hemoglobin < 12.0)
- Any condition or circumstance, including psychogenic factors, that preclude therapeutic compliance or otherwise make it unsafe to undergo an islet cell transplant.
- PSA > 4 in males
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Diabetes Research Institute
Miami, Florida, 33136
About this study
Official title: Immunomodulation for Islet Transplantation in Diabetes
The goal of islet cell transplantation in patients with Type 1 Diabetes Mellitus is to provide constant normal blood glucose levels. This may eliminate the need for insulin altogether or provide a significant reduction in the amount of insulin necessary to maintain constant normal blood glucose levels. This normalization may prevent or slow progression of diabetic complications. Furthermore, the participant may enjoy a healthier lifestyle and a better quality of life.
If you meet the initial inclusion criteria for the trial, you must be able to give informed consent personally. Then you will need to participate in an extensive screening process that involves many standard tests and collection of laboratory samples to make sure that the transplant is suitable and safe for you.
Read the detailed description
The trial may/will utilize the following immunosuppressive medications: tacrolimus (life-long), sirolimus (life-long), daclizumab and infliximab You will be maintained on the lowest doses possible with all the medications.
GROUP (1A): The first four participants will be assigned to Group A. These participants will receive an islet cell transplant alone from two donors. They will receive the following immunosuppressive medications: tacrolimus (lifelong), sirolimus (lifelong), and daclizumab. They will not receive the immunosuppressive medication infliximab. GROUP (1B): The second four participants will be assigned to group B. These participants will receive an islet cell transplant alone from one donor. They will receive the following immunosuppressive medications: tacrolimus (lifelong), sirolimus (lifelong), daclizumab and infliximab. Patients in this group who are not able to stop injecting insulin by three months after the transplant may be eligible to receive a second islet cell transplant.
Further participants will alternate group assignments in the same above-mentioned manner. The participants in both groups will receive the following immunosuppressive medications for life, tacrolimus and sirolimus. All participants will be required to live no more than two hours from the transplantation center.
When the islets become available, you will be notified to come immediately to the hospital for your transplant. At that time numerous tests and laboratory samples will be performed to make sure you are ready and healthy for your transplant.
You will have your islet cell transplant done in a special radiology procedure room in a hospital. You will have local anesthetic in the area of your liver on your right side along with sedatives that will minimize any discomfort the procedure might cause. A very small (thin) needle will be inserted through your liver into your portal vein where the islet cells are then injected.
All participants will need to be followed at the Diabetes Research Institute after transplant for laboratory sampling, testing and for general islet cell transplant care.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- islet cell transplantation
- Keywords
- Type I Diabetes Mellitus, Immunosuppression, Islet Cell Transplantation, PercutaneousTranshepaticPortalVein Catheterization
- 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.
islet cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2001 (estimated)
- Study startJul 2000
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Rodolfo Alejandro, MD, Study director, University of Miami Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021788
- Sponsor's protocol ID
- DK55347 (completed)
- Other IDs
- DK55347
- Status last verified
- Jul 2010
- First submitted
- 4 Aug 2001
- Last updated
- 9 Jul 2010
- Results posted
- No
Publications
Alejandro R, Lehmann R, Ricordi C, Kenyon NS, Angelico MC, Burke G, Esquenazi V, Nery J, Betancourt AE, Kong SS, Miller J, Mintz DH. Long-term function (6 years) of islet allografts in type 1 diabetes. Diabetes. 1997 Dec;46(12):1983-9. doi: 10.2337/diab.46.12.1983.
PubMed 9392484McAlister VC, Gao Z, Peltekian K, Domingues J, Mahalati K, MacDonald AS. Sirolimus-tacrolimus combination immunosuppression. Lancet. 2000 Jan 29;355(9201):376-7. doi: 10.1016/S0140-6736(99)03882-9.
PubMed 10665560
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulation for Islet Transplantation in Diabetes
- ClinicalTrials.gov ID
- NCT00021788
- Acronym / sponsor ID
- DK55347 (completed)
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type I Diabetes Mellitus, Immunosuppression, Islet Cell Transplantation, PercutaneousTranshepaticPortalVein Catheterization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jul 2000
- Study completion
- Dec 2001
- First posted
- 6 Aug 2001 (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 goal of islet cell transplantation in patients with Type 1 Diabetes Mellitus is to provide constant normal blood glucose levels. This may eliminate the need for insulin altogether or provide a significant reduction in the amount of insulin necessary to maintain constant normal blood glucose levels. This normalization may prevent or slow progression of diabetic complications. Furthermore, the participant may enjoy a healthier lifestyle and a better quality of life.
If you meet the initial inclusion criteria for the trial, you must be able to give informed consent personally. Then you will need to participate in an extensive screening process that involves many standard tests and collection of laboratory samples to make sure that the transplant is suitable and safe for you.
Detailed description
The trial may/will utilize the following immunosuppressive medications: tacrolimus (life-long), sirolimus (life-long), daclizumab and infliximab You will be maintained on the lowest doses possible with all the medications.
GROUP (1A): The first four participants will be assigned to Group A. These participants will receive an islet cell transplant alone from two donors. They will receive the following immunosuppressive medications: tacrolimus (lifelong), sirolimus (lifelong), and daclizumab. They will not receive the immunosuppressive medication infliximab. GROUP (1B): The second four participants will be assigned to group B. These participants will receive an islet cell transplant alone from one donor. They will receive the following immunosuppressive medications: tacrolimus (lifelong), sirolimus (lifelong), daclizumab and infliximab. Patients in this group who are not able to stop injecting insulin by three months after the transplant may be eligible to receive a second islet cell transplant.
Further participants will alternate group assignments in the same above-mentioned manner. The participants in both groups will receive the following immunosuppressive medications for life, tacrolimus and sirolimus. All participants will be required to live no more than two hours from the transplantation center.
When the islets become available, you will be notified to come immediately to the hospital for your transplant. At that time numerous tests and laboratory samples will be performed to make sure you are ready and healthy for your transplant.
You will have your islet cell transplant done in a special radiology procedure room in a hospital. You will have local anesthetic in the area of your liver on your right side along with sedatives that will minimize any discomfort the procedure might cause. A very small (thin) needle will be inserted through your liver into your portal vein where the islet cells are then injected.
All participants will need to be followed at the Diabetes Research Institute after transplant for laboratory sampling, testing and for general islet cell transplant care.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Candidates must be between the ages of 18 and 65
- Candidates must have had IDDM for at least 5 years and been under physician care for at least 6 months prior to enrollment in trial.
- Eligible candidates will have poorly controlled insulin-dependent diabetes mellitus (IDDM) and manifest signs and symptoms severe enough to be incapacitating. These symptoms can include episodes of hypoglycemic unawareness (failure to recognize blood glucose levels < 54 mg/dl) or episodes requiring the assistance of others.
- Candidates may have poor diabetes control despite intensive insulin therapy (HbA1c > 8.0%).
- Creatinine clearance should be > 60 ml/min)
Key exclusion criteria (14 listed)
- Previous or concurrent organ transplant
- Previous or concurrent malignancy
- Untreated proliferative diabetic retinopathy
- Unstable cardiovascular status, including positive stress echocardiography (if > age 35)
- Active infections, including x-ray evidence of pulmonary infection
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 |
|---|---|---|
| islet cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2010.
- Background: PubMed 9392484Alejandro R, Lehmann R, Ricordi C, Kenyon NS, Angelico MC, Burke G, Esquenazi V, Nery J, Betancourt AE, Kong SS, Miller J, Mintz DH. Long-term function (6 years) of islet allografts in type 1 diabetes. Diabetes. 1997 Dec;46(12):1983-9. doi: 10.2337/diab.46.12.1983.
- Background: PubMed 10665560McAlister VC, Gao Z, Peltekian K, Domingues J, Mahalati K, MacDonald AS. Sirolimus-tacrolimus combination immunosuppression. Lancet. 2000 Jan 29;355(9201):376-7. doi: 10.1016/S0140-6736(99)03882-9.
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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.
Rodolfo Alejandro, MD study director
University of Miami Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing islet cell transplantation in people with Diabetes Mellitus, Type 1, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 14 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 9 Jul 2010. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00021788, which also lists 2 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 9 Jul 2010.