Stem Cell Educator Therapy in Type 1 Diabetes
This study is currently recruiting participants.
Verified October 2012 by Tianhe Stem Cell Biotechnologies Inc.
Sponsor:
Tianhe Stem Cell Biotechnologies Inc.
Collaborator:
Chinese government fundings
Information provided by (Responsible Party):
Yong Zhao, MD, PhD, Tianhe Stem Cell Biotechnologies Inc.
ClinicalTrials.gov Identifier:
NCT01350219
First received: May 3, 2011
Last updated: October 19, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes |
Device: Stem Cell Educator |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Tianhe Stem Cell Biotechnologies Inc.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 100 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 14 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350219
Contacts
| Contact: Yong Zhao, MD, PhD | 630 723 1968 | yzhaowhl@yahoo.com |
Locations
| China, Shandong | |
| General Hospital of Jinan Military Command | Recruiting |
| Jinan, Shandong, China, 250031 | |
| Contact: Zhaoshun Jiang, MD 86 13953104251 | |
| Sub-Investigator: Zhaoshun Jiang, MD | |
| Spain | |
| Hospital Universitario Central de Asturias | Recruiting |
| Oviedo, Asturias, Spain, 33006 | |
| Contact: Elias Delgado, MD 34 985108000 delgadoelias@uniovi.es | |
| Contact: Jesus Otero, MD 34 985108778 jesus.otero@sespa.princast.es | |
| Principal Investigator: Elias Delgado, MD | |
| Sub-Investigator: Jesus Otero, MD | |
Sponsors and Collaborators
Tianhe Stem Cell Biotechnologies Inc.
Chinese government fundings
Investigators
| Study Chair: | Yong Zhao, MD, PhD | Tianhe Stem Cell Biotechnologies Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Yong Zhao, MD, PhD, CEO, Tianhe Stem Cell Biotechnologies Inc. |
| ClinicalTrials.gov Identifier: | NCT01350219 History of Changes |
| Other Study ID Numbers: | 2010-037 |
| Study First Received: | May 3, 2011 |
| Last Updated: | October 19, 2012 |
| Health Authority: | China: Food and Drug Administration Spain: Ministry of Health |
Keywords provided by Tianhe Stem Cell Biotechnologies Inc.:
|
Cord blood stem cells Immune modulation Stem cell educator |
Autoimmunity Islet beta cell regeneration Type 1 diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013