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

NCT02057211 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-11-06

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

autologous mesenchymal stem cell transplantation

PROCEDURE

sham transplantation of mesenchymal stem cells

Placebo control for transplantation of mesenchymal stem cells

Sponsors & Collaborators

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Per-Ola Carlsson, MD, PhD · Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02057211 on ClinicalTrials.gov