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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Per-Ola Carlsson, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01068951
First received: February 16, 2010
Last updated: February 4, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Per-Ola Carlsson, Professor, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01068951     History of Changes
Other Study ID Numbers: AS2010-0180
Study First Received: February 16, 2010
Last Updated: February 4, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014