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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01996228
• Other study ID #: 2013-0002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2013
• Est. completion date: October 2019

Study information

• Verified date: February 2019
• Source: Tianhe Stem Cell Biotechnologies Inc.
• Contact: Yong Zhao, MD, PhD
• Phone: 001 630 723 1968
• Email: zhao[@]tianhecell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• 1. T1D patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association.

2. Children from 3 through 18 years old and body weight > 15 kg.

3. Presence of at least one autoantibody to the pancreatic islet ß cells (IA-2, GAD, ICA, ZnT8, or IAA).

4. Written informed consent from the child and child's parents or legal representative.

Exclusion Criteria:

• 1. Any clinically significant diseases in liver, kidney, and heart.

2. Additional exclusion criteria include no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency

3. Significantly abnormal hematology results at screening.

4. Presence of any infection diseases or inflammation conditions, including active skin infections, flu, fever, upper or lower respiratory track infections.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Stem Cell Educator

Locations

Country	Name	City	State
China	The Second Xiangya Hospital	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Tianhe Stem Cell Biotechnologies Inc.	Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (4)

Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Yin Z, Li H, Zhang Y, Diao Y, Li Y, Chen Y, Sun X, Fisk MB, Skidgel R, Holterman M, Prabhakar B, Mazzone T. Reversal of type 1 diabetes via islet ß cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Med. 2012 Jan 10;10:3. doi: 10.1186/1741-7015-10-3. — View Citation

Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Zhou H, Yin Z, Chen Y, Zhang Y, Wang S, Shen J, Thaker H, Jain S, Li Y, Diao Y, Chen Y, Sun X, Fisk MB, Li H. Targeting insulin resistance in type 2 diabetes via immune modulation of cord blood-derived multipotent stem cells (CB-SCs) in stem cell educator therapy: phase I/II clinical trial. BMC Med. 2013 Jul 9;11:160. doi: 10.1186/1741-7015-11-160. — View Citation

Zhao Y, Mazzone T. Human cord blood stem cells and the journey to a cure for type 1 diabetes. Autoimmun Rev. 2010 Dec;10(2):103-7. doi: 10.1016/j.autrev.2010.08.011. Epub 2010 Aug 20. Review. — View Citation

Zhao Y. Stem cell educator therapy and induction of immune balance. Curr Diab Rep. 2012 Oct;12(5):517-23. doi: 10.1007/s11892-012-0308-1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autoimmune control	Before treatment, test autoimmune-related markers as baseline; After treatment for 90 days, repeat testing autoimmune-related markers.	90 days post treatment
Secondary	Metabolic control	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.	3-24 months post treatment

External Links

•   Tianhe Stem Cell Biotechnologies