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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01996228

Enrollment

Registered

2013-11-27

Start date

2013-11-30

Completion date

2019-10-31

Last updated

2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes, autoimmune, cord blood stem cell, stem cell educator, immune modulation, children, Control autoimmunity, stimulate the regeneration of islet beta cells

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.

Interventions

DEVICEStem Cell Educator

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactYong Zhao, MD, PhD

zhao@tianhecell.com001 630 723 1968

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026