Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells
NCT ID: NCT01068951
Last Updated: 2014-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2010-06-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Mesenchymal stem cells
Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.
Control
No interventions assigned to this group
Interventions
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Mesenchymal stem cells
Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
40 Years
ALL
No
Sponsors
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Uppsala University Hospital
OTHER
Responsible Party
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Per-Ola Carlsson
Professor
Principal Investigators
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Per-Ola Carlsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital
Locations
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Uppsala University Hospital
Uppsala, , Sweden
Countries
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References
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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.
Other Identifiers
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AS2010-0180
Identifier Type: -
Identifier Source: org_study_id
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