Using stem cell therapy to treat Type 1 Diabetes

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

This study is testing whether a new stem cell therapy can help people with Type 1 Diabetes by using their own immune cells to improve insulin production and lower blood sugar levels.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Throne Biotechnologies Inc. (industry)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 2 sites (Hackensack, New Jersey and 1 other locations)
• Trial ID: NCT04011020 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Stem Cell Educator (SCE) therapy to modulate the immune response in patients with Type 1 Diabetes (T1D). The therapy utilizes the patient's own immune cells, which are educated by cord blood stem cells to promote immune tolerance and potentially reverse autoimmunity. The process involves circulating the patient's blood through a specialized device that allows for the co-culture of immune cells and stem cells, aiming to improve insulin production and reduce blood sugar levels. The trial will assess the safety and efficacy of this innovative approach in a controlled setting.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 14 and older who have been recently diagnosed with Type 1 Diabetes and meet specific immunological criteria.

Not a fit: Patients with severe liver dysfunction or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could lead to improved management of Type 1 Diabetes and potentially reduce the need for insulin in patients.

How similar studies have performed: Previous studies using similar stem cell approaches have shown promising results in reversing autoimmunity in Type 1 Diabetes, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Adult patients ( 14 years)
2. Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes.
3. Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet Cells (IAA, IA2, GAD 65, ZnT8).
4. Fasting C-peptide level \> 0.3 ng/ml
5. HbA1C \< 10% at enrollment
6. Recent diagnosis (within two years of enrollment)
7. Adequate venous access for apheresis
8. Must be equipped with a continuous glucose monitoring system (CGMS)
9. Ability to provide informed consent
10. 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.
11. Must agree to comply with all study requirements and be willing to complete all study visits

Exclusion Criteria:

1. AST or ALT 2 \> x upper limit of normal.
2. Abnormal bilirubin (total bilirubin \> 1.2 mg/dL, direct bilirubin \> 0.4 mg/dL)
3. Creatinine \> 2.0 mg/dl.
4. Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
5. Known active infection such as Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
6. Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers
7. Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
8. Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)
9. Anticoagulation other than ASA.
10. Hemoglobin \< 10 g/dl or platelets \< 100 k/ml
11. Is unable or unwilling to provide informed consent
12. Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation

Where this trial is running

Hackensack, New Jersey and 1 other locations

• Hackensack Meridian Health — Hackensack, New Jersey, United States (ACTIVE_NOT_RECRUITING)
• Throne Biotechnologies — Paramus, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: YONG ZHAO, MD,PhD

Conditions: Type 1 Diabetes