A Phase 2 interventional study of Stem Cell Educator in Type 1 Diabetes, sponsored by Throne Biotechnologies Inc.. Status unknown at 4 sites in 2 countries. Open to participants aged 14 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by Throne Biotechnologies Inc. · Phase 2, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Throne Biotechnologies Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Before treatment, test autoimmune-related markers as baseline; After treatment for 30 days, repeat testing autoimmune-related markers.
Time frame: 30 days post treatment
Metabolic control
Before treatment, test for C-peptide levels as baseline; After treatment, test C-peptide levels on the 3rd month;
Time frame: 3 months
Analysis of islet beta cell function
1. Test for C-peptide levels on the 6th month; 2. Full evaluation of islet beta cell function after one year.
Time frame: 6 months
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Throne Biotechnologies Inc.