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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068951
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : February 5, 2014
Information provided by (Responsible Party):
Per-Ola Carlsson, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Biological: Mesenchymal stem cells Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open Study to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells in Treatment of Recently Diagnosed Patients With Type 1 Diabetes Mellitus
Study Start Date : June 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

No Intervention: Control

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01068951

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Uppsala University Hospital
Uppsala, Sweden, SE-75185
Sponsors and Collaborators
Uppsala University Hospital
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Principal Investigator: Per-Ola Carlsson, MD, PhD Uppsala University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Per-Ola Carlsson, Professor, Uppsala University Hospital Identifier: NCT01068951    
Other Study ID Numbers: AS2010-0180
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014
Keywords provided by Per-Ola Carlsson, Uppsala University Hospital:
type 1 diabetes
mesenchymal stem cells
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases