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Clinical Trials/NCT01219465
NCT01219465
Unknown
Phase 1

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

Qingdao University1 site in 1 country50 target enrollmentSeptember 2010
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ConditionsDiabetes MellitusDiabetes Mellitus, Type 1Mesenchymal Stem CellsUmbilical Cord

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Qingdao University
Enrollment
50
Locations
1
Primary Endpoint
C peptide release test
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
December 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Qingdao University

Eligibility Criteria

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 \>
  • •Severe or acute organ damage.
  • •Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
  • •Severe psychiatric disorder.
  • •Presence of malignancy.

Outcomes

Primary Outcomes

C peptide release test

Time Frame: 3 months

Secondary Outcomes

  • Immunologic reconstitution parameters(3 months)
  • Exogenous insulin dose(3 months)
  • blood glucose(3 months)
  • glycosylated Hemoglobin A1c(3 months)
  • Number of severe and documented hypoglycemic events(3 months)

Study Sites (1)

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