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
PHASE2
100 participants
INTERVENTIONAL
2010-09-30
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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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.
14 Years
60 Years
ALL
Yes
Sponsors
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Chinese government fundings
UNKNOWN
Throne Biotechnologies Inc.
INDUSTRY
Responsible Party
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Yong Zhao, MD, PhD
CEO
Principal Investigators
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Yong Zhao, MD, PhD
Role: STUDY_CHAIR
Throne Biotechnologies Inc.
Locations
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The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
General Hospital of Jinan Military Command
Jinan, Shandong, China
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Countries
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Central Contacts
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Facility Contacts
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Zhaoshun Jiang, MD
Role: primary
References
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Delgado E, Perez-Basterrechea M, Suarez-Alvarez B, Zhou H, Revuelta EM, Garcia-Gala JM, Perez S, Alvarez-Viejo M, Menendez E, Lopez-Larrea C, Tang R, Zhu Z, Hu W, Moss T, Guindi E, Otero J, Zhao Y. Modulation of Autoimmune T-Cell Memory by Stem Cell Educator Therapy: Phase 1/2 Clinical Trial. EBioMedicine. 2015 Nov 5;2(12):2024-36. doi: 10.1016/j.ebiom.2015.11.003. eCollection 2015 Dec.
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, 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.
Zhao Y, Lin B, Darflinger R, Zhang Y, Holterman MJ, Skidgel RA. Human cord blood stem cell-modulated regulatory T lymphocytes reverse the autoimmune-caused type 1 diabetes in nonobese diabetic (NOD) mice. PLoS One. 2009;4(1):e4226. doi: 10.1371/journal.pone.0004226. Epub 2009 Jan 19.
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.
Study Documents
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Document Type: 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.
View DocumentRelated Links
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Click here for more information regarding the Stem Cell Educator therapy in clinical trials
Other Identifiers
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2010-037
Identifier Type: -
Identifier Source: org_study_id
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