Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Qingdao University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Qingdao University
Information provided by:
Qingdao University
ClinicalTrials.gov Identifier:
NCT01219465
First received: October 12, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Mesenchymal Stem Cells Umbilical Cord |
Biological: umbilical cord mesenchymal stem cells |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes |
Resource links provided by NLM:
Further study details as provided by Qingdao University:
Primary Outcome Measures:
- C peptide release test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Exogenous insulin dose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- blood glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- glycosylated Hemoglobin A1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Number of severe and documented hypoglycemic events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Immunologic reconstitution parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: umbilical cord mesenchymal stem cells
Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells
|
Biological: umbilical cord mesenchymal stem cells
Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.
Other Name: mesenchymal stem cells
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219465
Locations
| China, Shandong | |
| Stem Cell Research Center of Medical School Hospital of Qingdao University | |
| Qingdao, Shandong, China, 266003 | |
Sponsors and Collaborators
Qingdao University
Investigators
| Study Director: | Yangang Wang, MD Phd | The Affiliated Hospital of Medical College of Qingdao University |
More Information
No publications provided
| Responsible Party: | Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University |
| ClinicalTrials.gov Identifier: | NCT01219465 History of Changes |
| Other Study ID Numbers: | MSCT1DM003 |
| Study First Received: | October 12, 2010 |
| Last Updated: | October 12, 2010 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Qingdao University:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 mesenchymal stem cells Umbilical cord |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013