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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02057211
• Other study ID #: AS Dnr2013/195
• Status: Terminated
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2020
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Biological:
• autologous mesenchymal stem cell transplantation

Procedure:
• sham transplantation of mesenchymal stem cells
Placebo control for transplantation of mesenchymal stem cells

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?-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.