Type 1 Diabetes MellitusPhase 2NCT02057211
Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
A Phase 2 study testing autologous mesenchymal stem cell transplantation in people with Type 1 Diabetes Mellitus, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to preserve insulin production and beta-cell mass in recently diagnosed patients with type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- autologous mesenchymal stem cell transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to Nov 2017
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- fasting C-peptide >0.12 nmol/l
- within three weeks of diagnosis of type 1 diabetes
Who cannot join
- body mass index (BMI) >30
- unstable cardiovascular status incl. New York Heart Association (NYHA) class III/IV
- patients with known or previous malignancy
- active infections incl. serological evidence of infection with HIV, Treponema pallidum, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
- immune suppressive treatment
- women being pregnant or nursing, or women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to preserve insulin production and beta-cell mass in recently diagnosed patients with type 1 diabetes mellitus. The hypothesis to be tested is that an increased number of circulating mesenchymal stem cells will provide immune modulatory properties, and thereby stop the immune process in islets causing progressive beta-cell death.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- autologous mesenchymal stem cell transplantation, sham transplantation of mesenchymal stem cells
- 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.
autologous mesenchymal stem cell transplantationBiological
sham transplantation of mesenchymal stem cellsProcedure or surgery
Placebo control for transplantation of mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| sham transplantation of mesenchymal stem cells | Placebo comparator | control arm with sham transplantation Receives: Procedure: sham transplantation of mesenchymal stem cells |
| autologous mesenchymal stem cell transplantation | Active comparator | Active arm with transplantation of cells Receives: Biological: autologous mesenchymal stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
∆-change of C-peptide Area Under the Curve (AUC) (0-120 min) for a mixed meal tolerance test at two year follow-up when compared to pre-treatment values at enrolment.
Measured: ∆-change will be assessed as a difference between two years after transplantation/sham transplantation of mesenchymal stem cells when compared to before transplantation/sham transplantation, i.e. at time 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: Changed regulations of culture procedure
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per-Ola Carlsson, Uppsala University Hospital
- Investigators
- Per-Ola Carlsson, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057211
- Sponsor's protocol ID
- AS Dnr2013/195
- Status last verified
- Nov 2020
- First submitted
- 4 Feb 2014
- Last updated
- 6 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
- ClinicalTrials.gov ID
- NCT02057211
- Acronym / sponsor ID
- AS Dnr2013/195
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changed regulations of culture procedure
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 7 Feb 2014 (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.
This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to preserve insulin production and beta-cell mass in recently diagnosed patients with type 1 diabetes mellitus. The hypothesis to be tested is that an increased number of circulating mesenchymal stem cells will provide immune modulatory properties, and thereby stop the immune process in islets causing progressive beta-cell death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham transplantation of mesenchymal stem cells | Placebo comparator | Procedure: sham transplantation of mesenchymal stem cellscontrol arm with sham transplantation |
| autologous mesenchymal stem cell transplantation | Active comparator | Biological: autologous mesenchymal stem cell transplantationActive arm with transplantation of cells |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- fasting C-peptide >0.12 nmol/l
- within three weeks of diagnosis of type 1 diabetes
Key exclusion criteria (6 listed)
- body mass index (BMI) >30
- unstable cardiovascular status incl. New York Heart Association (NYHA) class III/IV
- patients with known or previous malignancy
- active infections incl. serological evidence of infection with HIV, Treponema pallidum, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
- immune suppressive treatment
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 |
|---|---|---|
| autologous mesenchymal stem cell transplantation | Biological | autologous mesenchymal stem cell transplantation |
| sham transplantation of mesenchymal stem cellsPlacebo control for transplantation of mesenchymal stem cells | Procedure or surgery | sham transplantation of mesenchymal stem cells |
Primary outcome
∆-change of C-peptide Area Under the Curve (AUC) (0-120 min) for a mixed meal tolerance test at two year follow-up when compared to pre-treatment values at enrolment.
Time frame: ∆-change will be assessed as a difference between two years after transplantation/sham transplantation of mesenchymal stem cells when compared to before transplantation/sham transplantation, i.e. at time 0.
Results and safety
The study was stopped early (reason given: Changed regulations of culture procedure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
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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.
Per-Ola Carlsson, MD, PhD principal investigator
Uppsala University Hospital
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 autologous mesenchymal stem cell transplantation in people with Type 1 Diabetes Mellitus, run by Uppsala University Hospital at 1 site in Sweden.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Nov 2020. 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 Sweden. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Changed regulations of culture procedure). Results are not available in the source record.
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.
What does the primary outcome measure?
∆-change of C-peptide Area Under the Curve (AUC) (0-120 min) for a mixed meal tolerance test at two year follow-up when compared to pre-treatment values at enrolment. (time frame: ∆-change will be assessed as a difference between two years after transplantation/sham transplantation of mesenchymal stem cells when compared to before transplantation/sham transplantation, i.e. at time 0.). 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 6 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.