Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
NCT ID: NCT01996228
Last Updated: 2019-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2013-11-30
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Stem Cell Educator
Interventions
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Stem Cell Educator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
14 Years
ALL
No
Sponsors
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Second Xiangya Hospital of Central South University
OTHER
Throne Biotechnologies Inc.
INDUSTRY
Responsible Party
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Yong Zhao, MD, PhD
Associate Scientist
Principal Investigators
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Yong Zhao, MD,PhD
Role: STUDY_CHAIR
Tianhe Stem Cell Biotechnologies
Zhiguang Zhou, Md,PhD
Role: PRINCIPAL_INVESTIGATOR
Second Xiangya Hospital of Central South University
Locations
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The Second Xiangya Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Related Links
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Tianhe Stem Cell Biotechnologies
Other Identifiers
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2013-0002
Identifier Type: -
Identifier Source: org_study_id
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