Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy

Phase 1

• Conditions: Type 1 Diabetes
• Interventions: Device: Stem Cell Educator

• Registration Number: NCT01996228
• Lead Sponsor: Throne Biotechnologies Inc.

Brief Summary

Type 1 diabetes (T1D) is an autoimmune disease that usually occurs in children and reduces their pancreatic islet beta cells and thereby limits insulin production. Millions of individuals worldwide have T1D, and the number of children with diagnosed or undiagnosed T1D is increasing annually. Insulin supplementation is not a cure. It does not halt the persistent autoimmune response, nor can it reliably prevent devastating complications such as neuronal and cardiovascular diseases, blindness, and kidney failure. A true cure has proven elusive despite intensive research pressure over the past 25 years. Notably, Dr.Zhao and his team have successfully developed a groundbreaking technology Stem Cell Educator therapy (Zhao Y, et al.BMC Medicine 2011, 2012). To date, clinical trials in adult patients have demonstrated the safety and efficacy of Stem Cell Educator therapy for the treatment of T1D and other autoimmune-associated diseases. Here, the investigators will evaluate the safety and efficacy of Stem Cell Educator therapy in children with type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-11-27
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-02
• Last Update Posted: 2019-02-05
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1. T1D patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association.

  2. Children from 3 through 18 years old and body weight > 15 kg.

  3. Presence of at least one autoantibody to the pancreatic islet β cells (IA-2, GAD, ICA, ZnT8, or IAA).

  4. Written informed consent from the child and child's parents or legal representative.

Exclusion Criteria

• 1. Any clinically significant diseases in liver, kidney, and heart.

  2. Additional exclusion criteria include no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency

  3. Significantly abnormal hematology results at screening.

  4. Presence of any infection diseases or inflammation conditions, including active skin infections, flu, fever, upper or lower respiratory track infections.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cord Blood-derived multipotent stem cells	Stem Cell Educator	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 in patients.

Primary Outcome Measures

Name	Time	Method
Autoimmune control	90 days post treatment	Before treatment, test autoimmune-related markers as baseline; After treatment for 90 days, repeat testing autoimmune-related markers.

Secondary Outcome Measures

Name	Time	Method
Metabolic control	3-24 months post treatment	Before treatment, test for C-peptide levels and HbA1C as baseline; After treatment, test C-peptide levels and HbA1C on the 3rd month.; 1. Analysis of islet beta cell function; 2. Test for C-peptide levels on every 6 month; 3. Full evaluation of islet beta cell function after two years.

Trial Locations

Locations (1)

The Second Xiangya Hospital; 🇨🇳 Changsha, Hunan, China