NCT01219465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus

Timeline
Completed

Started Sep 2010

Typical duration for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 13, 2010

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

October 12, 2010

Last Update Submit

October 12, 2010

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Mesenchymal Stem CellsUmbilical Cord

Keywords

Diabetes MellitusDiabetes Mellitus, Type 1mesenchymal stem cellsUmbilical cord

Outcome Measures

Primary Outcomes (1)

  • C peptide release test

    3 months

Secondary Outcomes (5)

  • Exogenous insulin dose

    3 months

  • blood glucose

    3 months

  • glycosylated Hemoglobin A1c

    3 months

  • Number of severe and documented hypoglycemic events

    3 months

  • Immunologic reconstitution parameters

    3 months

Study Arms (1)

umbilical cord mesenchymal stem cells

EXPERIMENTAL

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells

Biological: umbilical cord mesenchymal stem cells

Interventions

umbilical cord mesenchymal stem cellsBIOLOGICAL

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

Also known as: mesenchymal stem cells
umbilical cord mesenchymal stem cells

Eligibility Criteria

Age3 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
  • Ability to provide written informed consent from patients or Child guardian.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yangang Wang, MD Phd

    The Affiliated Hospital of Qingdao University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

October 13, 2010

Record last verified: 2010-09

Locations

CN(1)