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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 : 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, Tianhe Stem Cell Biotechnologies Inc.

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE November 27, 2013
Last Update Posted Date February 5, 2019
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01996228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
Official Title  ICMJE Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Device: Stem Cell Educator
Other Names:
  • Procedure: Apharesis and Stem Cell Educator Therapy
  • Biological: Cord blood
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yong Zhao, MD, PhD 001 630 723 1968 zhao@tianhecell.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01996228
Other Study ID Numbers  ICMJE 2013-0002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yong Zhao, MD, PhD, Tianhe Stem Cell Biotechnologies Inc.
Study Sponsor  ICMJE Tianhe Stem Cell Biotechnologies Inc.
Collaborators  ICMJE Second Xiangya Hospital of Central South University
Investigators  ICMJE
Study Chair: Yong Zhao, MD,PhD Tianhe Stem Cell Biotechnologies
Principal Investigator: Zhiguang Zhou, Md,PhD Second Xiangya Hospital of Central South University
PRS Account Tianhe Stem Cell Biotechnologies Inc.
Verification Date February 2019

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