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

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Stem Cell Educator
Sponsored by
Throne Biotechnologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, autoimmune, cord blood stem cell, stem cell educator, immune modulation, children, Control autoimmunity, stimulate the regeneration of islet beta cells

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Xiangya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cord Blood-derived multipotent stem cells

Arm Description

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.

Outcomes

Primary Outcome Measures

Autoimmune control
Before treatment, test autoimmune-related markers as baseline; After treatment for 90 days, repeat testing autoimmune-related markers.

Secondary Outcome Measures

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.

Full Information

First Posted
November 21, 2013
Last Updated
February 2, 2019
Sponsor
Throne Biotechnologies Inc.
Collaborators
Second Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT01996228
Brief Title
Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
Official Title
Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Throne Biotechnologies Inc.
Collaborators
Second Xiangya Hospital of Central South University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, autoimmune, cord blood stem cell, stem cell educator, immune modulation, children, Control autoimmunity, stimulate the regeneration of islet beta cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cord Blood-derived multipotent stem cells
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Stem Cell Educator
Other Intervention Name(s)
Procedure: Apharesis and Stem Cell Educator Therapy, Biological: Cord blood
Primary Outcome Measure Information:
Title
Autoimmune control
Description
Before treatment, test autoimmune-related markers as baseline; After treatment for 90 days, repeat testing autoimmune-related markers.
Time Frame
90 days post treatment
Secondary Outcome Measure Information:
Title
Metabolic control
Description
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.
Time Frame
3-24 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Zhao, MD, PhD
Phone
001 630 723 1968
Email
zhao@tianhecell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Zhao, MD,PhD
Organizational Affiliation
Tianhe Stem Cell Biotechnologies
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhiguang Zhou, Md,PhD
Organizational Affiliation
Second Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Li, MD, PhD
Email
info.T1D@tianhecell.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22233865
Citation
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 beta 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.
Results Reference
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PubMed Identifier
23837842
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.
Results Reference
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PubMed Identifier
22833322
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.
Results Reference
background
PubMed Identifier
20728583
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.
Results Reference
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Links:
URL
http://www.tianhecell.com
Description
Tianhe Stem Cell Biotechnologies

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

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