Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
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|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.
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|