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

NCT ID: NCT02057211

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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sham transplantation of mesenchymal stem cells

control arm with sham transplantation

Group Type PLACEBO_COMPARATOR

sham transplantation of mesenchymal stem cells

Intervention Type PROCEDURE

Placebo control for transplantation of mesenchymal stem cells

autologous mesenchymal stem cell transplantation

Active arm with transplantation of cells

Group Type ACTIVE_COMPARATOR

autologous mesenchymal stem cell transplantation

Intervention Type BIOLOGICAL

Interventions

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autologous mesenchymal stem cell transplantation

Intervention Type BIOLOGICAL

sham transplantation of mesenchymal stem cells

Placebo control for transplantation of mesenchymal stem cells

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Per-Ola Carlsson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per-Ola Carlsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

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Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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AS Dnr2013/195

Identifier Type: -

Identifier Source: org_study_id