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

NCT ID: NCT01219465

Last Updated: 2010-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Diabetes Mellitus, Type 1 Mesenchymal Stem Cells Umbilical Cord

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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umbilical cord mesenchymal stem cells

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells

Group Type EXPERIMENTAL

umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

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

Interventions

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umbilical cord mesenchymal stem cells

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

Intervention Type BIOLOGICAL

Other Intervention Names

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mesenchymal stem cells

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Stem Cell Research Center of Medical School Hospital of Qingdao University

Principal Investigators

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Yangang Wang, MD Phd

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

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Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Countries

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China

Other Identifiers

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MSCT1DM003

Identifier Type: -

Identifier Source: org_study_id