Clinical trial NCT01350219: Stem Cell Educator Therapy in Type 1 Diabetes
Official title: Phase 2 Study of Stem Cell Educator Therapy in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Cord blood stem cells
Immune modulation
Stem cell educator
Autoimmunity
Islet beta cell regeneration
Type 1 diabetes
Lead sponsor: Throne Biotechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Chinese government fundings
First posted: 2011-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Autoimmune control
timeFrame: 30 days post treatment
Secondary outcomes:
measure: Metabolic control
timeFrame: 3 months
measure: Analysis of islet beta cell function
timeFrame: 6 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Jinan
country: China
facility: General Hospital of Jinan Military Command
state: Shandong
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
Study officials:
affiliation: Throne Biotechnologies Inc.
name: Yong Zhao, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
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.
citation: 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.