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

Uppsala University Hospital

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Biological: Mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01068951

AS2010-0180

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Mesenchymal stem cells

Active Comparator group

Description:

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.

Treatment:

Biological: Mesenchymal stem cells

Control

No Intervention group