Stem Cell Educator Therapy in Type 1 Diabetes
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Stem Cell Educator Therapy in Type 1 Diabetes|
- Autoimmune control [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]Before treatment, test autoimmune-related markers as baseline; After treatment for 30 days, repeat testing autoimmune-related markers.
- Metabolic control [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Test for C-peptide levels on the 6th month;
- Full evaluation of islet beta cell function after one year.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
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.
|Contact: Yong Zhao, MD, PhD||630 723 firstname.lastname@example.org|
|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||Tianhe Stem Cell Biotechnologies Inc.|