Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
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ClinicalTrials.gov Identifier: NCT02057211 |
Recruitment Status :
Terminated
(Changed regulations of culture procedure)
First Posted : February 7, 2014
Last Update Posted : November 6, 2020
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Condition or disease | Intervention/treatment | Phase |
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Type 1 Diabetes Mellitus | Biological: autologous mesenchymal stem cell transplantation Procedure: sham transplantation of mesenchymal stem cells | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study |
Actual Study Start Date : | April 2014 |
Actual Primary Completion Date : | November 2017 |
Actual Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: sham transplantation of mesenchymal stem cells
control arm with sham transplantation
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Procedure: sham transplantation of mesenchymal stem cells
Placebo control for transplantation of mesenchymal stem cells |
Active Comparator: autologous mesenchymal stem cell transplantation
Active arm with transplantation of cells
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Biological: autologous mesenchymal stem cell transplantation |
- ∆-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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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057211
Sweden | |
Uppsala University Hospital | |
Uppsala, Sweden, SE-75185 |
Principal Investigator: | Per-Ola Carlsson, MD, PhD | Uppsala University Hospital |
Responsible Party: | Per-Ola Carlsson, Professor, Uppsala University Hospital |
ClinicalTrials.gov Identifier: | NCT02057211 |
Other Study ID Numbers: |
AS Dnr2013/195 |
First Posted: | February 7, 2014 Key Record Dates |
Last Update Posted: | November 6, 2020 |
Last Verified: | November 2020 |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |