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
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: Stem Cell Educator
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Tianhe Stem Cell Biotechnologies Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • Procedure: Apharesis and Stem Cell Educator Therapy
  • Biological: Cord blood

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996228

Contacts
Contact: Yong Zhao, MD, PhD 001 630 723 1968 zhao@tianhecell.com

Locations
China, Hunan
The Second Xiangya Hospital Recruiting
Changsha, Hunan, China, 410011
Contact: Xia Li, MD, PhD       info.T1D@tianhecell.com   
Sponsors and Collaborators
Tianhe Stem Cell Biotechnologies Inc.
Second Xiangya Hospital of Central South University
Investigators
Study Chair: Yong Zhao, MD,PhD Tianhe Stem Cell Biotechnologies
Principal Investigator: Zhiguang Zhou, Md,PhD Second Xiangya Hospital of Central South University
  More Information

Additional Information:
Publications:
Responsible Party: Yong Zhao, MD, PhD, Associate Scientist, Tianhe Stem Cell Biotechnologies Inc.
ClinicalTrials.gov Identifier: NCT01996228     History of Changes
Other Study ID Numbers: 2013-0002
Study First Received: November 21, 2013
Last Updated: March 18, 2014
Health Authority: China: Ministry of Health

Keywords provided by Tianhe Stem Cell Biotechnologies Inc.:
Type 1 diabetes
autoimmune
cord blood stem cell
stem cell educator
immune modulation
children
Control autoimmunity
stimulate the regeneration of islet beta cells

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014