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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Mesenchymal stem cells
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring type 1 diabetes, mesenchymal stem cells, intervention

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mesenchymal stem cells

Control

Arm Description

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.

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
February 16, 2010
Last Updated
February 4, 2014
Sponsor
Uppsala University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01068951
Brief Title
Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes, mesenchymal stem cells, intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cells
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cells
Intervention Description
Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per-Ola Carlsson, MD, PhD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25204974
Citation
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.
Results Reference
derived

Learn more about this trial

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

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