Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
This study is currently recruiting participants.
Verified June 2013 by Third Military Medical University
Sponsor:
Lu Debin
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
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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:
- Ability to provide written informed consent from patients or Child guardian
- Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •
Exclusion Criteria:
- Body Mass Index >30
- Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- Infectious diseases, e.g. HIV infection, or hepatitis B or C infection
- Presence of malignancy
Contacts and Locations
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 June 18, 2013