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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Tianhe Stem Cell Biotechnologies Inc.
Sponsor:
Collaborator:
Second Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Yong Zhao, MD, PhD, Tianhe Stem Cell Biotechnologies Inc.
ClinicalTrials.gov Identifier:
NCT01996228
First received: November 21, 2013
Last updated: March 18, 2014
Last verified: March 2014

November 21, 2013
March 18, 2014
November 2013
October 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01996228 on ClinicalTrials.gov Archive Site
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.

  1. Analysis of islet beta cell function
  2. Test for C-peptide levels on every 6 month;
  3. Full evaluation of islet beta cell function after two years.
Same as current
Not Provided
Not Provided
 
Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
Device: Stem Cell Educator
Other Names:
  • Procedure: Apharesis and Stem Cell Educator Therapy
  • Biological: Cord blood
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.
Intervention: Device: Stem Cell Educator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
October 2015   (final data collection date for primary outcome measure)

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 β 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.

Both
6 Years to 14 Years
No
Contact: Yong Zhao, MD, PhD 001 630 723 1968 zhao@tianhecell.com
China
 
NCT01996228
2013-0002
Not Provided
Yong Zhao, MD, PhD, Tianhe Stem Cell Biotechnologies Inc.
Tianhe Stem Cell Biotechnologies Inc.
Second Xiangya Hospital of Central South University
Study Chair: Yong Zhao, MD,PhD Tianhe Stem Cell Biotechnologies
Principal Investigator: Zhiguang Zhou, Md,PhD Second Xiangya Hospital of Central South University
Tianhe Stem Cell Biotechnologies Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP