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CompletedNCT01068951Updated Feb 5, 2014

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

An interventional study of Mesenchymal stem cells in Type 1 Diabetes, sponsored by Uppsala University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-02-05.

Sponsored by Uppsala University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • type 1 diabetes
  • mesenchymal stem cells
  • intervention
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 20 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Uppsala University Hospital is the lead sponsor of 70 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    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.

    Biological: Mesenchymal stem cells

  • No intervention
    Control

Interventions

  • BiologicalMesenchymal stem cells

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year after intervention

07

Study locations

1 site
  • Uppsala University Hospital
    Uppsala, SE-75185, Sweden
08

References and documents

Publications

  • Carlsson PO, Schwarcz E, Korsgren O, Le Blanc K. Preserved beta-cell function in type 1 diabetes by mesenchymal stromal cells. Diabetes. 2015 Feb;64(2):587-92. doi: 10.2337/db14-0656. Epub 2014 Sep 9. PubMed 25204974 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01068951
Lead sponsor
Uppsala University Hospital
Responsible party
Per-Ola Carlsson (Professor, Uppsala University Hospital) — Principal investigator
First posted
Feb 17, 2010
Start date
Jun 2010
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Feb 5, 2014

Study contacts

Per-Ola Carlsson, MD, PhD
principal investigator · Uppsala University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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