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

Phase 2

Terminated

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Procedure: sham transplantation of mesenchymal stem cells; Biological: autologous mesenchymal stem cell transplantation

• Registration Number: NCT02057211
• Lead Sponsor: Uppsala University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-07
• Study Start: 2014-04
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham transplantation of mesenchymal stem cells	sham transplantation of mesenchymal stem cells	control arm with sham transplantation
autologous mesenchymal stem cell transplantation	autologous mesenchymal stem cell transplantation	Active arm with transplantation of cells

Primary Outcome Measures

Name	Time	Method
∆-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.

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden