NCT04011020Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
Type 1 diabetes (T1D) is a T cell-mediated autoimmune disease that causes a deficit of pancreatic islet beta cells. Millions of individuals worldwide have T1D, and incidence increases annually. Several recent clinical trials point to the need for an approach that produces comprehensive immune modulation at both the local pancreatic and systemic levels. Stem Cell Educator (SCE) therapy offers comprehensive immune modulation at both the local and systemic levels in T1D by using a patient's own immune cells (including platelets) that are "educated" by cord blood stem cells. Tested clinically in more than 300 patients, SCE therapy has shown lasting reversal in autoimmunity in T1D patients, including improved C-peptide levels, reduced median glycated hemoglobin A1C (HbA1C) values, and decreased median daily usage of insulin. SCE therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent Cord Blood Stem Cells (CB-SC) in vitro, and returns the "educated" autologous immune cells to the patient's circulation.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 4 Jul 2019
- Start date
- 20 Sept 2022
- Primary completion date
- 20 Oct 2027
- Lead sponsor
- Yong Zhao, MD, PhD
- Diseases
- Type 1 diabetes
- NCT number
- NCT04011020
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 80
- From 20 Sept 2022 to the primary completion date, 20 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
Other illness
- Known active infection such as Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV), HTLV (human T-cell leukemia-lymphoma virus cAB), or active tuberculosis.
- Presence of any other autoimmune diseases (Hashimoto's thyroiditis, celiac disease, lupus, rheumatoid arthritis, scleroderma, etc.).
- Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation.
Lab values
- AST or ALT 2 \> x upper limit of normal.
- Abnormal bilirubin (total bilirubin \> 1.2 mg/dL, direct bilirubin \> 0.4 mg/dL).
- Creatinine \> 2.0 mg/dl.
- Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
- Hemoglobin \< 10 g/dl or platelets \< 100 k/ml.
- Subjects with leukopenia, total white blood cells (WBC) count \< 4000/uL.
Other
- Pregnant or breastfeeding women.
- Anticoagulation other than ASA.
- Patient or patient's surrogate is unable or unwilling to voluntarily sign an informed consent form.
Who the study is looking for
- Pediatric and adult patients (\>10 years).
- Must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) Guidelines.
- Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet beta Cells (IAA, IA2, GAD 65, ZnT8).
- Fasting C-peptide level \> 0.3 ng/ml.
- Adequate venous access for apheresis.
- Ability to provide informed consent or assent.
- For female patients only, willingness to use FDA-recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356451.pdf) until 6 months post treatment.
- Must agree to comply with all study requirements and be willing to complete all study visits.
Age in the registry: 10 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Throne Biotechnologies Coordinator of this site? Confirm its status | Paramus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.