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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Lu Debin, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01157403
First received: July 2, 2010
Last updated: June 15, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Evidence of Liver Transplantation
Biological: Autologous transplantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • C peptide release test [ Time Frame: 6 Months after intervention ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously
Other Name: SWH2010A19

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   10 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157403

Contacts
Contact: Chen bing, doctor 903262619@qq.com
Contact: lu debin, doctor ldb2005056@yahoo.com.cn

Locations
China, Chongqing
Endocrine Department, the south west Hospital of the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400038
Contact: Chen Bing, doctor       cb@mail.tmmu.com.cn   
Contact: Lu Debin, doctor       ldb2005056@yahoo.COM.CN   
Sponsors and Collaborators
Lu Debin
Investigators
Study Director: chen bing, doctor Endocrine Department, the south west Hospital of the Third Military Medical University
  More Information

No publications provided

Responsible Party: Lu Debin, Southwest Hospital, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01157403     History of Changes
Other Study ID Numbers: ldb201001
Study First Received: July 2, 2010
Last Updated: June 15, 2013
Health Authority: China: Ethics Committee

Keywords provided by Third Military Medical University:
mesenchymal stem cells

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014