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NCT01219465 Clinical Trial

Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01219465
Other study ID # MSCT1DM003
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received October 12, 2010
Last updated October 12, 2010
Start date September 2010
Est. completion date December 2012

Study information
Verified date September 2010
Source Qingdao University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 35 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• umbilical cord mesenchymal stem cells
Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.

Locations
Country Name City State
China Stem Cell Research Center of Medical School Hospital of Qingdao University Qingdao Shandong

Sponsors (1)
Lead Sponsor Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary C peptide release test 3 months No
Secondary Exogenous insulin dose 3 months No
Secondary blood glucose 3 months No
Secondary glycosylated Hemoglobin A1c 3 months No
Secondary Number of severe and documented hypoglycemic events 3 months No
Secondary Immunologic reconstitution parameters 3 months No
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