Stem Cell Educator Therapy in Type 1 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01350219|
Recruitment Status : Unknown
Verified February 2019 by Yong Zhao, MD, PhD, Tianhe Stem Cell Biotechnologies Inc..
Recruitment status was: Recruiting
First Posted : May 9, 2011
Last Update Posted : February 5, 2019
|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.
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 firstname.lastname@example.org|
|The First Hospital of Hebei Medical University||Recruiting|
|Shijiazhuang, Hebei, China, 050031|
|Contact: Huimin Zhou, MD email@example.com|
|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 firstname.lastname@example.org|
|Contact: Jesus Otero, MD 34 985108778 email@example.com|
|Principal Investigator: Elias Delgado, MD|
|Sub-Investigator: Jesus Otero, MD|
|Study Chair:||Yong Zhao, MD, PhD||Tianhe Stem Cell Biotechnologies Inc.|