Back to results

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

Primary Purpose

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

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

umbilical cord mesenchymal stem cells

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Diabetes Mellitus, Type 1, mesenchymal stem cells, Umbilical cord

Eligibility Criteria

3 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stem Cell Research Center of Medical School Hospital of Qingdao University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

umbilical cord mesenchymal stem cells

Arm Description

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells

Outcomes

Primary Outcome Measures

C peptide release test

Secondary Outcome Measures

Exogenous insulin dose

blood glucose

glycosylated Hemoglobin A1c

Number of severe and documented hypoglycemic events

Immunologic reconstitution parameters

Full Information

NCT ID

NCT01219465

First Posted

October 12, 2010

Last Updated

October 12, 2010

Sponsor

Qingdao University

1. Study Identification

Unique Protocol Identification Number

NCT01219465

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Qingdao University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Diabetes Mellitus, Diabetes Mellitus, Type 1, mesenchymal stem cells, Umbilical cord

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

umbilical cord mesenchymal stem cells

Arm Type

Experimental

Arm Description

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells

Intervention Type

Biological

Intervention Name(s)

umbilical cord mesenchymal stem cells

Other Intervention Name(s)

mesenchymal stem cells

Intervention Description

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

Primary Outcome Measure Information:

Title

C peptide release test

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Exogenous insulin dose

Time Frame

3 months

Title

blood glucose

Time Frame

3 months

Title

glycosylated Hemoglobin A1c

Time Frame

3 months

Title

Number of severe and documented hypoglycemic events

Time Frame

3 months

Title

Immunologic reconstitution parameters

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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 >30. Severe or acute organ damage. Infectious diseases, e.g. HIV infection, or hepatitis B or C infection. Severe psychiatric disorder. Presence of malignancy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yangang Wang, MD Phd

Organizational Affiliation

The Affiliated Hospital of Qingdao University

Official's Role

Study Director

Facility Information:

Facility Name

Stem Cell Research Center of Medical School Hospital of Qingdao University

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266003

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs