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Stem Cell Educator Therapy in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01350219
Recruitment Status : Unknown
Verified February 2019 by Yong Zhao, MD, PhD, Throne Biotechnologies Inc..
Recruitment status was:  Recruiting
First Posted : May 9, 2011
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Chinese government fundings
Information provided by (Responsible Party):
Yong Zhao, MD, PhD, Throne Biotechnologies Inc.

Study Description
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Brief Summary:
The translational potential to the clinical applications of cord blood stem cells has increased enormously in recent years, mainly because of its unique advantages including no risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid availability, and large resource worldwide. Human cord blood contains several types of stem cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess multiple biological properties including the expression of embryonic stem (ES) cell characteristics, giving rise to different types of cells and immune modulation. Specifically, CB-SC can function as an immune modulator that can lead to control of the immune responses, which could in turn be used as a new approach to overcome the autoimmunity of Type 1 diabetes (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Educator therapy in T1D patients.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Stem Cell Educator Therapy in Type 1 Diabetes
Study Start Date : September 2010
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 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 stem cell
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.
 Device: Stem Cell Educator
For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 8 ~ 9 hrs.


Outcome Measures
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Primary Outcome Measures :
  1. Autoimmune control [ Time Frame: 30 days post treatment ]
    Before treatment, test autoimmune-related markers as baseline; After treatment for 30 days, repeat testing autoimmune-related markers.


Secondary Outcome Measures :
  1. Metabolic control [ Time Frame: 3 months ]
    Before treatment, test for C-peptide levels as baseline; After treatment, test C-peptide levels on the 3rd month;

  2. Analysis of islet beta cell function [ Time Frame: 6 months ]
    1. Test for C-peptide levels on the 6th month;
    2. Full evaluation of islet beta cell function after one year.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients were screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association 2010. Other key inclusion criteria were presence of at least one autoantibody to the pancreatic islet β cells.

Exclusion Criteria:

  • Exclusion criteria were any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria were no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.
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): NCT01350219


Contacts
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Contact: Yong Zhao, MD, PhD 630 723 1968 yzhaowhl@yahoo.com

Locations
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China, Hebei
The First Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050031
Contact: Huimin Zhou, MD       zhouhuimindoctor@163.com   
Principal Investigator: Huimin Zhou, MD         
China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Xia Li, MD       T1DMCT@gmail.com   
Principal Investigator: Zhiguang Zhou, MD, PhD         
China, Shandong
General Hospital of Jinan Military Command Recruiting
Jinan, Shandong, China, 250031
Contact: Zhaoshun Jiang, MD    86 13953104251      
Sub-Investigator: Zhaoshun Jiang, MD         
Spain
Hospital Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33006
Contact: Elias Delgado, MD    34 985108000    delgadoelias@uniovi.es   
Contact: Jesus Otero, MD    34 985108778    jesus.otero@sespa.princast.es   
Principal Investigator: Elias Delgado, MD         
Sub-Investigator: Jesus Otero, MD         
Sponsors and Collaborators
Throne Biotechnologies Inc.
Chinese government fundings
Investigators
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Study Chair: Yong Zhao, MD, PhD Throne Biotechnologies Inc.
More Information
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Additional Information:

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: PMC5689778
Yong Zhao*, Zhaoshun Jiang, Elias Delgado, Heng Li, Huimin Zhou, Wei Hu, Marcos Perez-Basterrechea, Anna Janostakova, Qidong Tan, Jing Wang, Mao Mao, Zhaohui Yin, Ye Zhang, Ying Li, Quanhai Li, Jing Zhou, Yunxiang Li, Eva Martinez Revuelta, Jose Maria García-Gala, Honglan Wang, Silvia Perez-López, Maria Alvarez-Viejo, Edelmiro Menendez, Thomas Moss, Edward Guindi, Jesus Otero. Platelets-derived mitochondria display embryonic stem cell markers and improve pancreatic islet β-cell function in humans. STEM CELLS Translational Medicine. July 7, 2017. DOI: 10.1002/sctm.17-0078.

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yong Zhao, MD, PhD, CEO, Throne Biotechnologies Inc.
ClinicalTrials.gov Identifier: NCT01350219    
Other Study ID Numbers: 2010-037
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Keywords provided by Yong Zhao, MD, PhD, Throne Biotechnologies Inc.:
Cord blood stem cells
Immune modulation
Stem cell educator
 Autoimmunity
Islet beta cell regeneration
Type 1 diabetes
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