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Trial record 2 of 24 for:    stem cells | Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation Studies | Diabetes Mellitus, Type 1

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01068951
First Posted: February 17, 2010
Last Update Posted: February 5, 2014
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.
Information provided by (Responsible Party):
Per-Ola Carlsson, Uppsala University Hospital
  Purpose
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 Intervention
Type 1 Diabetes Biological: Mesenchymal stem cells

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Per-Ola Carlsson, Uppsala University Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: June 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01068951


Locations
Sweden
Uppsala University Hospital
Uppsala, Sweden, SE-75185
Sponsors and Collaborators
Uppsala University Hospital
Investigators
Principal Investigator: Per-Ola Carlsson, MD, PhD Uppsala University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per-Ola Carlsson, Professor, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01068951     History of Changes
Other Study ID Numbers: AS2010-0180
First Submitted: February 16, 2010
First Posted: February 17, 2010
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
intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases