Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
Type 1 diabetes (T1D) is an autoimmune disease that usually occurs in children and reduces their pancreatic islet beta cells and thereby limits insulin production. Millions of individuals worldwide have T1D, and the number of children with diagnosed or undiagnosed T1D is increasing annually. Insulin supplementation is not a cure. It does not halt the persistent autoimmune response, nor can it reliably prevent devastating complications such as neuronal and cardiovascular diseases, blindness, and kidney failure. A true cure has proven elusive despite intensive research pressure over the past 25 years. Notably, Dr.Zhao and his team have successfully developed a groundbreaking technology Stem Cell Educator therapy (Zhao Y, et al.BMC Medicine 2011, 2012). To date, clinical trials in adult patients have demonstrated the safety and efficacy of Stem Cell Educator therapy for the treatment of T1D and other autoimmune-associated diseases. Here, the investigators will evaluate the safety and efficacy of Stem Cell Educator therapy in children with type 1 diabetes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy|
- Autoimmune control [ Time Frame: 90 days post treatment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||November 2013|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|