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Status unknownNCT01157403Updated Jun 18, 2013

Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes

A Phase 2/3 interventional study of Autologous transplantation in Evidence of Liver Transplantation, sponsored by Lu Debin. Status unknown at 1 site in China. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2013-06-18.

Sponsored by Lu Debin · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
10 Years to 40 Years
Sex
All
01

Study summary

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.

Read the detailed description

Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously

02

Conditions studied

  • Evidence of Liver Transplantation

Keywords

  • mesenchymal stem cells
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 80 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

This is the only study on the registry with Lu Debin as lead sponsor.

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

04

Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Ability to provide written informed consent from patients or Child guardian
  2. Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •

Exclusion criteria

Exclusion Criteria:

  1. Body Mass Index >30
  2. Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
  3. Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
  4. Infectious diseases, e.g. HIV infection, or hepatitis B or C infection
  5. Presence of malignancy
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    mesenchymal stem cells

    To study the safety and efficacy of autologous transplantation of bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.

    Biological: Autologous transplantation

Interventions

  • BiologicalAutologous transplantation

    Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously

    Also known as: SWH2010A19

06

What researchers measure

Primary outcomes

  1. C peptide release test

    The concentration of c-peptide at 90 minutes after the start of the C-peptide release test at 24 Months following the infusion or not with bone marrow mesenchymal stem cells

    Time frame: 6 Months after intervention

07

Study locations

1 of 1 sites recruiting
  • Endocrine Department, the south west Hospital of the Third Military Medical University
    Chongqing, Chongqing 400038, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01157403
Lead sponsor
Lu Debin
Responsible party
Lu Debin (Southwest Hospital, Third Military Medical University) — Sponsor-investigator
First posted
Jul 7, 2010
Start date
Jul 2010
Primary completion
Jul 2014 (estimated)
Completion
Aug 2014 (estimated)
Last update
Jun 18, 2013

Study contacts

Chen bing, doctor
Contact
903262619@qq.com
lu debin, doctor
Contact
ldb2005056@yahoo.com.cn
chen bing, doctor
study director · Endocrine Department, the south west Hospital of the Third Military Medical University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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