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

Uppsala University Hospital

Status and phase

Terminated

Phase 2

Conditions

Type 1 Diabetes Mellitus

Treatments

Procedure: sham transplantation of mesenchymal stem cells

Biological: autologous mesenchymal stem cell transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02057211

AS Dnr2013/195

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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