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Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study

Sponsor
Uppsala University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT02057211
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
43
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: autologous mesenchymal stem cell transplantation
  • Procedure: sham transplantation of mesenchymal stem cells
 Phase 2

Study Design

Study Type:
Interventional
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 :
Apr 1, 2014
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: sham transplantation of mesenchymal stem cells

control arm with sham transplantation

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

Biological: autologous mesenchymal stem cell transplantation

Outcome Measures

Primary Outcome Measures

  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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uppsala University Hospital Uppsala Sweden SE-75185

Sponsors and Collaborators

  • Uppsala University Hospital

Investigators

  • Principal Investigator: Per-Ola Carlsson, MD, PhD, Uppsala University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Per-Ola Carlsson, Professor, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT02057211
Other Study ID Numbers:
  • AS Dnr2013/195
First Posted:
Feb 7, 2014
Last Update Posted:
Nov 6, 2020
Last Verified:
Nov 1, 2020
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 6, 2020