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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 : Suspended (Updated regulations of culture procedure)
First Posted : February 7, 2014
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Per-Ola Carlsson, Uppsala University Hospital

Study Description
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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
Type 1 Diabetes Mellitus Biological: autologous mesenchymal stem cell transplantation Procedure: sham transplantation of mesenchymal stem cells Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Study Start Date : February 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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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
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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. [ 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sweden
Uppsala University Hospital
Uppsala, Sweden, SE-75185
Sponsors and Collaborators
Uppsala University Hospital
Investigators
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Principal Investigator: Per-Ola Carlsson, MD, PhD Uppsala University Hospital
More Information
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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: April 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases