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

Open Study to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells in Treatment of Recently Diagnosed Patients With Type 1 Diabetes Mellitus

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01068951

Enrollment

Registered

2010-02-17

Start date

2010-06-30

Completion date

2013-09-30

Last updated

2014-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes, mesenchymal stem cells, intervention

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.

Interventions

BIOLOGICALMesenchymal stem cells

Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026