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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01157403
Recruitment Status : Unknown
Verified June 2013 by Lu Debin, Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : July 7, 2010
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
Lu Debin, Third Military Medical University

Tracking Information
First Submitted Date  ICMJE July 2, 2010
First Posted Date  ICMJE July 7, 2010
Last Update Posted Date June 18, 2013
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2013)
C peptide release test [ Time Frame: 6 Months after intervention ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
C peptide release test [ Time Frame: 24 Months after intervention ]
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
Change History Complete list of historical versions of study NCT01157403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
Official Title  ICMJE Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
Brief 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.
Detailed Description Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Evidence of Liver Transplantation
Intervention  ICMJE Biological: Autologous transplantation
Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously
Other Name: SWH2010A19
Study Arms  ICMJE 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.
Intervention: Biological: Autologous transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 6, 2010)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01157403
Other Study ID Numbers  ICMJE ldb201001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lu Debin, Third Military Medical University
Study Sponsor  ICMJE Lu Debin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: chen bing, doctor Endocrine Department, the south west Hospital of the Third Military Medical University
PRS Account Third Military Medical University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP