This trial is active, not recruiting.

Conditions diabetes mellitus, diabetes mellitus, type 1, mesenchymal stem cells, umbilical cord
Treatment umbilical cord mesenchymal stem cells
Phase phase 1/phase 2
Sponsor Qingdao University
Start date September 2010
End date September 2012
Trial size 50 participants
Trial identifier NCT01219465, MSCT1DM003


The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells
umbilical cord mesenchymal stem cells mesenchymal stem cells
Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.

Primary Outcomes

C peptide release test
time frame: 3 months

Secondary Outcomes

Exogenous insulin dose
time frame: 3 months
blood glucose
time frame: 3 months
glycosylated Hemoglobin A1c
time frame: 3 months
Number of severe and documented hypoglycemic events
time frame: 3 months
Immunologic reconstitution parameters
time frame: 3 months

Eligibility Criteria

Male or female participants from 3 years up to 35 years old.

Inclusion Criteria: - Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks. - Ability to provide written informed consent from patients or Child guardian. Exclusion Criteria: - diabetic ketoacidosis. - evidence of retinopathy at baseline. - Body Mass Index >30. - Severe or acute organ damage. - Infectious diseases, e.g. HIV infection, or hepatitis B or C infection. - Severe psychiatric disorder. - Presence of malignancy.

Additional Information

Official title Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes
Description Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Qingdao University.