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Type 1 DiabetesPhase 3NCT04011020

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

A Phase 3 study testing Stem Cell Educator therapy in people with Type 1 Diabetes, run by Yong Zhao, MD, PhD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 10 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Stem Cell Educator therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
20 Sep 2022to 20 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Known active infection such as Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV), HTLV (human T-cell leukemia-lymphoma virus cAB), or active tuberculosis.
  • Pregnant or breastfeeding women.
Show all 13Show fewer
  • Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
  • Presence of any other autoimmune diseases (Hashimoto's thyroiditis, celiac disease, lupus, rheumatoid arthritis, scleroderma, etc.).
  • Anticoagulation other than ASA.
  • Hemoglobin < 10 g/dl or platelets < 100 k/ml.
  • Subjects with leukopenia, total white blood cells (WBC) count < 4000/uL.
  • Patient or patient's surrogate is unable or unwilling to voluntarily sign an informed consent form.
  • Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Throne Biotechnologies

    Paramus, New Jersey, 07652

Other trials in United States

About this study

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.

Read the detailed description

The SCE device is made of a hydrophobic material from FDA-approved (USP Class VI) dishes that tightly binds stem cells CB-SC without interfering with their immune modulating capability. During SCE therapy, a patient's peripheral blood mononuclear cells (PBMC) are collected by leukapheresis and co-cultured with adherent cord-blood-derived multipotent stem cells (CB-SC) in vitro, after which the "educated" PBMC are returned to the patient's circulation via infusion. Over the last 15 years, this technology has been evaluated through international multicenter clinical studies conducted in the United States, China, and Spain. These studies have demonstrated the clinical safety and efficacy of SCE therapy in treating type 1 diabetes (T1D), alopecia areata (AA), and other autoimmune conditions, including reversal of T1D-associated autoimmunity and treatment of other immune dysfunction-associated diseases, such as alopecia areata, type 2 diabetes (T2D), Crohn's disease and long-COVID.

Conditions
Type 1 Diabetes
Being tested
Stem Cell Educator therapy
Keywords
Type 1 diabetes, stem cells, cord blood, treatment, immune modulation
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stem Cell Educator therapyCombination product

    Patients with T1D will be evaluated by the study principal investigator or sub-investigators. Informed consent will be obtained at the initial screen meeting. Subjects who meet all criteria will be scheduled for treatment. All enrolled subjects will receive treatment with the Stem Cell Educator (SCE) therapy consisting of a single session of mononuclear cells (MNC) collection by apheresis where peripheral blood will be processed on day 1. The MNC product will then be exposed overnight to the SCE and on day 2 the product Gleukocell will be infused intravenously back to the patient.

Study groups in NCT04011020
Study groupRoleWhat they receive
Treatment of T1D with Stem Cell Educator therapyExperimentalRecruited T1D subjects will receive one treatment with SCE therapy.
Receives: Combination Product: Stem Cell Educator therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fasting C-peptide levels

    Change in fasting C-peptide levels at Month 3

    Measured: 3 month

Secondary outcomes (7)

  1. Change in HbA1C levels

    Change in HbA1C levels at Month 1 and Month 3

    Measured: 3 months

  2. Change daily insulin requirement

    Change daily insulin requirement at Month 1 and Month 3

    Measured: 3 months

  3. Proportion of subjects achieving restoration of fasting C-peptide levels to the normal range

    Proportion of subjects achieving restoration of fasting C-peptide levels to the normal range at Month 1 and Month 3

    Measured: 3 months

  4. Proportion of subjects achieving complete insulin independence

    Proportion of subjects achieving complete insulin independence at Month 1 and Month 3

    Measured: 3 month

  5. Changes in immune markers

    Changes in regulatory T-cells and activated T-cells at Month 1 and Month 3

    Measured: 3 month

  6. Changes in immune markers

    Changes in memory T-cells and naïve T-cells at Month 1 and Month 3

    Measured: 3 month

  7. Changes in immune markers

    Changes in inflammatory chemokine CXCL16 at Month 1 and Month 3

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2019
  2. Study start20 Sep 2022
  3. Primary completion20 Oct 2027 (estimated)
  4. Study completion20 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Treatment group receive Stem Cell Educator therapy
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04011020
Sponsor's protocol ID
2019-TH-002
Status last verified
Sep 2026
First submitted
4 Jul 2019
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Zhao Y, Knight CM, Jiang Z, Delgado E, Van Hoven AM, Ghanny S, Zhou Z, Zhou H, Yu H, Hu W, Li H, Li X, Perez-Basterrechea M, Zhao L, Zhao Y, Giangola J, Weinberg R, Mazzone T. Stem Cell Educator therapy in type 1 diabetes: From the bench to clinical trials. Autoimmun Rev. 2022 May;21(5):103058. doi: 10.1016/j.autrev.2022.103058. Epub 2022 Jan 31.

    PubMed 35108619

  • Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Yin Z, Li H, Zhang Y, Diao Y, Li Y, Chen Y, Sun X, Fisk MB, Skidgel R, Holterman M, Prabhakar B, Mazzone T. Reversal of type 1 diabetes via islet beta cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Med. 2012 Jan 10;10:3. doi: 10.1186/1741-7015-10-3.

    PubMed 22233865

  • Zhao Y. Stem cell educator therapy and induction of immune balance. Curr Diab Rep. 2012 Oct;12(5):517-23. doi: 10.1007/s11892-012-0308-1.

    PubMed 22833322

  • Delgado E, Perez-Basterrechea M, Suarez-Alvarez B, Zhou H, Revuelta EM, Garcia-Gala JM, Perez S, Alvarez-Viejo M, Menendez E, Lopez-Larrea C, Tang R, Zhu Z, Hu W, Moss T, Guindi E, Otero J, Zhao Y. Modulation of Autoimmune T-Cell Memory by Stem Cell Educator Therapy: Phase 1/2 Clinical Trial. EBioMedicine. 2015 Nov 5;2(12):2024-36. doi: 10.1016/j.ebiom.2015.11.003. eCollection 2015 Dec.

    PubMed 26844283

  • Zhao Y, Jiang Z, Delgado E, Li H, Zhou H, Hu W, Perez-Basterrechea M, Janostakova A, Tan Q, Wang J, Mao M, Yin Z, Zhang Y, Li Y, Li Q, Zhou J, Li Y, Martinez Revuelta E, Maria Garcia-Gala J, Wang H, Perez-Lopez S, Alvarez-Viejo M, Menendez E, Moss T, Guindi E, Otero J. Platelet-Derived Mitochondria Display Embryonic Stem Cell Markers and Improve Pancreatic Islet beta-cell Function in Humans. Stem Cells Transl Med. 2017 Aug;6(8):1684-1697. doi: 10.1002/sctm.17-0078. Epub 2017 Jul 7.

    PubMed 28685960

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stem Cell Educator therapy in people with Type 1 Diabetes, run by Yong Zhao, MD, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fasting C-peptide levels (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04011020, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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