Type 1 Diabetes MellitusPhase 1/2NCT00646724
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
A Phase 1/2 study testing cotransplantation of islet and mesenchymal stem cell in people with Type 1 Diabetes Mellitus, run by Fuzhou General Hospital at 1 site in China.
Trial summary
The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- cotransplantation of islet and mesenchymal stem cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Jan 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients age 18 to 60 years of age
- Ability to provide written informed consent
- Manifest signs and symptoms that are severe enough to be incapacitating
- Patients with poor diabetes control (HbA1c > 7% but < 12%)
- Progressive diabetic complications
Who cannot join
- age < 18 years or > 60 years
- diabetic history < 5 years
- BMI > 27
- body weight > 80 kg
- exogenous insulin requirement > 1 unit/kg/day
- severe anemia (male < 8 g/dl, female < 7 g/dl)
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- low white blood cell count (< 3000/dl)
- liver dysfunction
- Active infection including hepatitis B, hepatitis C, HIV, or TB
- panel reactive antibody > 20%
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuzhou General Hospital
Fuzhou, Fujian, 350025
About this study
The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from inflammatory damage, immunological modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin and improve β-cell function.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- cotransplantation of islet and mesenchymal stem cell
- Keywords
- Islets of Langerhans Transplantation, Mesenchymal Stem Cells, Type 1 Diabetes Mellitus
- 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.
cotransplantation of islet and mesenchymal stem cellBiological
islet of allograft and MSCs of autograft
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | cotransplantation of islet and mesenchymal stem cell Receives: Biological: cotransplantation of islet and mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exogenous insulin requirement
Measured: 5
Hemoglobin A1c
Measured: 5
Glucose and C-peptide levels
Measured: 5
Secondary outcomes (5)
liver function
Measured: 5
kidney function
Measured: 5
Portal vein Ultrasound
Measured: 1
autoantibodies
Measured: 5
Complete Blood Count
Measured: 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2012 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jianming Tan, professor, Principal investigator, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646724
- Sponsor's protocol ID
- fuzhough0712
- Other IDs
- fuzhough0712
- Status last verified
- Jun 2011
- First submitted
- 25 Mar 2008
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00646724
- Acronym / sponsor ID
- fuzhough0712
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Islets of Langerhans Transplantation, Mesenchymal Stem Cells, Type 1 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 28 Mar 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 study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from inflammatory damage, immunological modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin and improve β-cell function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: cotransplantation of islet and mesenchymal stem cellcotransplantation of islet and mesenchymal stem cell |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female patients age 18 to 60 years of age
- Ability to provide written informed consent
- Manifest signs and symptoms that are severe enough to be incapacitating
- Patients with poor diabetes control (HbA1c > 7% but < 12%)
- Progressive diabetic complications
Key exclusion criteria (11 listed)
- age < 18 years or > 60 years
- diabetic history < 5 years
- BMI > 27
- body weight > 80 kg
- exogenous insulin requirement > 1 unit/kg/day
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 |
|---|---|---|
| cotransplantation of islet and mesenchymal stem cellislet of allograft and MSCs of autograft | Biological | 1 |
Primary outcome
Exogenous insulin requirement
Time frame: 5
Hemoglobin A1c
Time frame: 5
Glucose and C-peptide levels
Time frame: 5
5 secondary outcomes
liver function
Time frame: 5
kidney function
Time frame: 5
Portal vein Ultrasound
Time frame: 1
autoantibodies
Time frame: 5
Complete Blood Count
Time frame: 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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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.
Jianming Tan, professor principal investigator
Fuzhou General Hospital
1 site 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 cotransplantation of islet and mesenchymal stem cell in people with Type 1 Diabetes Mellitus, run by Fuzhou General Hospital at 1 site in China.
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 5 inclusion and 11 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 16 Jun 2011. 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 China. 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 Jianming Tan, Professor (008613375918000, TANJM156@YAHOO.COM.CN), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exogenous insulin requirement (time frame: 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2011.