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

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ClinicalTrials.gov Identifier: NCT01996228
Recruitment Status : Unknown
Verified February 2019 by Yong Zhao, MD, PhD, Throne Biotechnologies Inc..
Recruitment status was:  Recruiting
First Posted : November 27, 2013
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Second Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Yong Zhao, MD, PhD, Throne Biotechnologies Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Stem Cell Educator Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

    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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996228


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

Locations
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China, Hunan
The Second Xiangya Hospital Recruiting
Changsha, Hunan, China, 410011
Contact: Xia Li, MD, PhD       info.T1D@tianhecell.com   
Sponsors and Collaborators
Throne Biotechnologies Inc.
Second Xiangya Hospital of Central South University
Investigators
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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
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Additional Information:

Publications:

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Responsible Party: Yong Zhao, MD, PhD, Associate Scientist, Throne Biotechnologies Inc.
ClinicalTrials.gov Identifier: NCT01996228    
Other Study ID Numbers: 2013-0002
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Keywords provided by Yong Zhao, MD, PhD, Throne 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:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases