Stem Cell Educator Therapy in Type 1 Diabetes

Phase 2

• Conditions: Type 1 Diabetes

• Registration Number: NCT01350219
• Lead Sponsor: Throne Biotechnologies Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-02
• Last Update Posted: 2019-02-05
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Autoimmune control	30 days post treatment	Before treatment, test autoimmune-related markers as baseline; After treatment for 30 days, repeat testing autoimmune-related markers.

Secondary Outcome Measures

Name	Time	Method
Analysis of islet beta cell function	6 months	1. Test for C-peptide levels on the 6th month; 2. Full evaluation of islet beta cell function after one year.
Metabolic control	3 months	Before treatment, test for C-peptide levels as baseline; After treatment, test C-peptide levels on the 3rd month;

Trial Locations

Locations (4)

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

General Hospital of Jinan Military Command; 🇨🇳 Jinan, Shandong, China

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain