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Status unknownNCT01219465Updated Oct 13, 2010

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

A Phase 1/2 interventional study of umbilical cord mesenchymal stem cells in Diabetes Mellitus, Diabetes Mellitus, Type 1 and Mesenchymal Stem Cells, sponsored by Qingdao University. Status unknown at 1 site in China. Open to participants aged 3 Years to 35 Years. Per ClinicalTrials.gov, last updated 2010-10-13.

Sponsored by Qingdao University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
3 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Diabetes Mellitus
  • Diabetes Mellitus, Type 1
  • mesenchymal stem cells
  • Umbilical cord
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Qingdao University is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    umbilical cord mesenchymal stem cells

    Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells

    Biological: umbilical cord mesenchymal stem cells

Interventions

  • Biologicalumbilical cord mesenchymal stem cells

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

    Also known as: mesenchymal stem cells

06

What researchers measure

Primary outcomes

  1. C peptide release test

    Time frame: 3 months

Secondary outcomes

  1. Exogenous insulin dose

    Time frame: 3 months

  2. blood glucose

    Time frame: 3 months

  3. glycosylated Hemoglobin A1c

    Time frame: 3 months

  4. Number of severe and documented hypoglycemic events

    Time frame: 3 months

  5. Immunologic reconstitution parameters

    Time frame: 3 months

07

Study locations

1 site
  • Stem Cell Research Center of Medical School Hospital of Qingdao University
    Qingdao, Shandong 266003, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01219465
Lead sponsor
Qingdao University
First posted
Oct 13, 2010
Start date
Sep 2010
Primary completion
Sep 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Oct 13, 2010

Study contacts

Yangang Wang, MD Phd
study director · The Affiliated Hospital of Qingdao University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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