Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Throne Biotechnologies Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Autoimmune control
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •T1D patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association.
- •Children from 3 through 18 years old and body weight > 15 kg.
- •Presence of at least one autoantibody to the pancreatic islet β cells (IA-2, GAD, ICA, ZnT8, or IAA).
- •Written informed consent from the child and child's parents or legal representative.
Exclusion Criteria
- •Any clinically significant diseases in liver, kidney, and heart.
- •Additional exclusion criteria include no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency
- •Significantly abnormal hematology results at screening.
- •Presence of any infection diseases or inflammation conditions, including active skin infections, flu, fever, upper or lower respiratory track infections.
Arms & Interventions
Cord Blood-derived multipotent stem cells
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.
Intervention: Stem Cell Educator (Device)
Outcomes
Primary Outcomes
Autoimmune control
Time Frame: 90 days post treatment
Before treatment, test autoimmune-related markers as baseline; After treatment for 90 days, repeat testing autoimmune-related markers.
Secondary Outcomes
- Metabolic control(3-24 months post treatment)
Investigators
Yong Zhao, MD, PhD
Associate Scientist
Throne Biotechnologies Inc.