- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415726
Stem Cell Educator Therapy in Type 2 Diabetes
February 16, 2012 updated by: University of Illinois at Chicago
Type 2 diabetes is the most common form of diabetes.
The prevalence of diabetes has been markedly increased in recent years.
More and more children and young adults develop this devastating disease.
Despite of multiple factors (e.g., food, environmental, and genetic factors) contributing to the developing of diabetes, increasing evidence demonstrated that chronic inflammation and/or atuoimmunity are common issues and play key roles in the pathogenesis of type 2 diabetes, leading to the insulin resistance and the shortage of insulin-producing islet beta cells.
Thus, anti-inflammation is becoming a novel approach for the treatment of type 2 diabetes.
Evidence that multipotent stem cells derived from human cord blood (CB-SCs) can control inflammation and autoimmune responses by altering regulatory T cells (Tregs) and human islet beta cell-specific T cell clone in type 1 diabetes offers promise for a new approach to treat type 2 diabetes.
Here, the investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Stem Cell Educator therapy in T2D patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250031
- General Hospital of Jinan Military Command
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 for the autoimmune-related type 2 diabetes.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
Stem Cell Educator will be used for isolation and purification of cord blood stem cells for the treatment.
|
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 6 ~ 7 hrs.
|
Experimental: Stem Cell Educator
used for the isolation and purification of cord blood stem cells.
|
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 6 ~ 7 hrs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammation control
Time Frame: 30 days post treatment
|
Before treatment, test inflammation-related markers as baseline; After treatment for 30 days, repeat testing inflammation-related markers.
|
30 days post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic control
Time Frame: 3 months
|
Before treatment, test for HbA1C levels as baseline; After treatment, test HbA1C levels on the 3rd month
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yong Zhao, MD, PhD, Universtiy of Illinois at Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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, Dingeldein M, Guo C, Hwang D, Holterman MJ. New type of human blood stem cell: a double-edged sword for the treatment of type 1 diabetes. Transl Res. 2010 May;155(5):211-6. doi: 10.1016/j.trsl.2010.01.003. Epub 2010 Feb 12.
- 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, Jiang Z, Zhao T, Ye M, Hu C, Zhou H, Yin Z, Chen Y, Zhang Y, Wang S, Shen J, Thaker H, Jain S, Li Y, Diao Y, Chen Y, Sun X, Fisk MB, Li H. Targeting insulin resistance in type 2 diabetes via immune modulation of cord blood-derived multipotent stem cells (CB-SCs) in stem cell educator therapy: phase I/II clinical trial. BMC Med. 2013 Jul 9;11:160. doi: 10.1186/1741-7015-11-160.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
August 10, 2011
First Submitted That Met QC Criteria
August 11, 2011
First Posted (Estimate)
August 12, 2011
Study Record Updates
Last Update Posted (Estimate)
February 17, 2012
Last Update Submitted That Met QC Criteria
February 16, 2012
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on Stem Cell Educator
-
Throne Biotechnologies Inc.Chinese government fundingsUnknown
-
Throne Biotechnologies Inc.The First Hospital of Hebei Medical UniversityUnknown
-
Hackensack Meridian HealthActive, not recruitingDiabetes Mellitus Type 1United States
-
Throne Biotechnologies Inc.Second Xiangya Hospital of Central South UniversityUnknown
-
Throne Biotechnologies Inc.Not yet recruitingSevere Acute Respiratory Syndrome (SARS) Pneumonia
-
Throne Biotechnologies Inc.Hackensack Meridian HealthRecruiting
-
Throne Biotechnologies Inc.Chinese PLA General HospitalUnknown
-
Throne Biotechnologies Inc.RecruitingAlopecia Areata | Alopecia Totalis | Alopecia UniversalisUnited States
-
China Medical University HospitalUnknownIschemia | Ischemic Stroke | Brain Ischemia | Infarction, Middle Cerebral Artery | Ischaemic Cerebral InfarctionTaiwan
-
National Heart Institute, MexicoNational Center of Blood Transfusion Mexico.UnknownAcute Myocardial InfarctionMexico