Study Stopped
Changed regulations of culture procedure
Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
1 other identifier
interventional
10
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2014
CompletedFirst Posted
Study publicly available on registry
February 7, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedNovember 6, 2020
November 1, 2020
3.6 years
February 4, 2014
November 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
∆-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.
∆-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.
Study Arms (2)
sham transplantation of mesenchymal stem cells
PLACEBO COMPARATORcontrol arm with sham transplantation
autologous mesenchymal stem cell transplantation
ACTIVE COMPARATORActive arm with transplantation of cells
Interventions
Placebo control for transplantation of mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- fasting C-peptide \>0.12 nmol/l
- within three weeks of diagnosis of type 1 diabetes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uppsala University Hospital
Uppsala, SE-75185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per-Ola Carlsson, MD, PhD
Uppsala University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 4, 2014
First Posted
February 7, 2014
Study Start
April 1, 2014
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
November 6, 2020
Record last verified: 2020-11