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
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|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: Stem Cell Educator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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;
- Analysis of islet beta cell function [ Time Frame: 6 months ]
- Test for C-peptide levels on the 6th month;
- Full evaluation of islet beta cell function after one year.
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|Ages Eligible for Study:||14 Years to 60 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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 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.
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
|Contact: Yong Zhao, MD, PhD||630 723 email@example.com|
|The First Hospital of Hebei Medical University||Recruiting|
|Shijiazhuang, Hebei, China, 050031|
|Contact: Huimin Zhou, MD firstname.lastname@example.org|
|Principal Investigator: Huimin Zhou, MD|
|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|
|General Hospital of Jinan Military Command||Recruiting|
|Jinan, Shandong, China, 250031|
|Contact: Zhaoshun Jiang, MD 86 13953104251|
|Sub-Investigator: Zhaoshun Jiang, MD|
|Hospital Universitario Central de Asturias||Recruiting|
|Oviedo, Asturias, Spain, 33006|
|Contact: Elias Delgado, MD 34 985108000 email@example.com|
|Contact: Jesus Otero, MD 34 985108778 firstname.lastname@example.org|
|Principal Investigator: Elias Delgado, MD|
|Sub-Investigator: Jesus Otero, MD|
|Study Chair:||Yong Zhao, MD, PhD||Throne Biotechnologies Inc.|
Study Data/Documents: Clinical Study Report
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Yong Zhao, MD, PhD, CEO, Throne Biotechnologies Inc.|
|Other Study ID Numbers:||
|First Posted:||May 9, 2011 Key Record Dates|
|Last Update Posted:||February 5, 2019|
|Last Verified:||February 2019|
Cord blood stem cells
Stem cell educator
Islet beta cell regeneration
Type 1 diabetes
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases