- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02057211
Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
November 4, 2020 updated by: Per-Ola Carlsson, Uppsala University Hospital
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 Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Uppsala, Sweden, SE-75185
- Uppsala University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- fasting C-peptide >0.12 nmol/l
- within three weeks of diagnosis of type 1 diabetes
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: sham transplantation of mesenchymal stem cells
control arm with sham transplantation
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Placebo control for transplantation of mesenchymal stem cells
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ACTIVE_COMPARATOR: autologous mesenchymal stem cell transplantation
Active arm with transplantation of cells
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
∆-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.
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∆-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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2014
Primary Completion (ACTUAL)
November 1, 2017
Study Completion (ACTUAL)
November 1, 2017
Study Registration Dates
First Submitted
February 4, 2014
First Submitted That Met QC Criteria
February 5, 2014
First Posted (ESTIMATE)
February 7, 2014
Study Record Updates
Last Update Posted (ACTUAL)
November 6, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS Dnr2013/195
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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