Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
Primary Purpose
Type 1 Diabetes Mellitus
Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
autologous mesenchymal stem cell transplantation
sham transplantation of mesenchymal stem cells
Sponsored by
About this trial
This is an interventional prevention trial for Type 1 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
sham transplantation of mesenchymal stem cells
autologous mesenchymal stem cell transplantation
Arm Description
control arm with sham transplantation
Active arm with transplantation of cells
Outcomes
Primary Outcome Measures
∆-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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02057211
First Posted
February 4, 2014
Last Updated
November 4, 2020
Sponsor
Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02057211
Brief Title
Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
Official Title
Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Changed regulations of culture procedure
Study Start Date
April 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sham transplantation of mesenchymal stem cells
Arm Type
Placebo Comparator
Arm Description
control arm with sham transplantation
Arm Title
autologous mesenchymal stem cell transplantation
Arm Type
Active Comparator
Arm Description
Active arm with transplantation of cells
Intervention Type
Biological
Intervention Name(s)
autologous mesenchymal stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
sham transplantation of mesenchymal stem cells
Intervention Description
Placebo control for transplantation of mesenchymal stem cells
Primary Outcome Measure Information:
Title
∆-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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per-Ola Carlsson, MD, PhD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study
We'll reach out to this number within 24 hrs