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

NCT01068951 | Completed

• 1 other identifier: AS2010-0180
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; mesenchymal stem cells; intervention

Outcome Measures

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

  1 year after intervention

Study Arms (2)

Mesenchymal stem cells

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Interventions

Mesenchymal stem cells BIOLOGICAL

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

Mesenchymal stem cells

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, SE-75185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25204974 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Per-Ola Carlsson, MD, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 5, 2014

Record last verified: 2014-02

Locations

SE (1)