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Completed

NCT Number: NCT01068951

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital

Uppsala, SE-75185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mesenchymal stem cells

Biological

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

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

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 17, 2010
Registry last updated
Feb 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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