Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01996228|
Recruitment Status : Recruiting
First Posted : November 27, 2013
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: Stem Cell Educator||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Cord Blood-derived multipotent stem cells
Human cord blood-derived multipotent stem cells (CB-SC) display unique phenotypes, such as the expression of embryonic stem (ES) cell markers, multipotential of differentiations, very low immunogenecity, and immune modulations in patients.
Device: Stem Cell Educator
- Autoimmune control [ Time Frame: 90 days post treatment ]Before treatment, test autoimmune-related markers as baseline; After treatment for 90 days, repeat testing autoimmune-related markers.
- Metabolic control [ Time Frame: 3-24 months post treatment ]
Before treatment, test for C-peptide levels and HbA1C as baseline; After treatment, test C-peptide levels and HbA1C on the 3rd month.
- Analysis of islet beta cell function
- Test for C-peptide levels on every 6 month;
- Full evaluation of islet beta cell function after two years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996228
|Contact: Yong Zhao, MD, PhD||001 630 723 firstname.lastname@example.org|
|The Second Xiangya Hospital||Recruiting|
|Changsha, Hunan, China, 410011|
|Contact: Xia Li, MD, PhD info.T1D@tianhecell.com|
|Study Chair:||Yong Zhao, MD,PhD||Tianhe Stem Cell Biotechnologies|
|Principal Investigator:||Zhiguang Zhou, Md,PhD||Second Xiangya Hospital of Central South University|