Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Biological: Mesenchymal stem cells

• Registration Number: NCT01068951
• Lead Sponsor: Uppsala University Hospital

Brief Summary

The main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Study Start: 2010-06
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Ability to provide written informed consent
• Mentally stable and able to comply with the procedures of the study protocol
• Clinical history compatible with type 1 diabetes diagnosed less than 10 days of enrolment Stimulate c-peptide >0.1 nmol/l

Exclusion Criteria

• Patients with BMI>30
• Patients with unstable cardiovascular status
• Patients with active infections, unless treatment is not judged necessary by the investigators
• Patients with serological evidence of infection with HIV, hepatitis B or hepatitis C.
• Sexually active females who are not a) postmenopausal, b) surgically sterile or c) using an acceptable method of contraception: oral contraceptives, Norplant, Depo-provera and barrier devices combined with spermicidal gel are acceptable.
• Patients with known or previous malignancy. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with autologous MSC.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cells	Mesenchymal stem cells	Comparison of active treatment with autologous mesenchymal stem cells (in addition to standard treatment) to standard treatment of patients newly diagnosed with type 1 diabetes mellitus.

Primary Outcome Measures

Name	Time	Method
The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells	1 year after intervention

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden