Status:
RECRUITING
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Lead Sponsor:
Throne Biotechnologies Inc.
Collaborating Sponsors:
Hackensack Meridian Health
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
14+ years
Phase:
PHASE2
PHASE3
Brief 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. Severa...
Detailed Description
The SCE device is made of a hydrophobic material from FDA-approved (USP Class VI) dishes that tightly binds stem cells CB-SCs without interfering with their immune modulating capability. We originally...
Eligibility Criteria
Inclusion
- Adult patients ( 14 years)
- Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes.
- Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet Cells (IAA, IA2, GAD 65, ZnT8).
- Fasting C-peptide level \> 0.3 ng/ml
- HbA1C \< 10% at enrollment
- Recent diagnosis (within two years of enrollment)
- Adequate venous access for apheresis
- Must be equipped with a continuous glucose monitoring system (CGMS)
- Ability to provide informed consent
- 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
Exclusion
- 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, or Human Immunodeficiency Virus (HIV)
- Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers
- 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 (lupus, rheumatoid arthritis, scleroderma, etc.)
- Anticoagulation other than ASA.
- Hemoglobin \< 10 g/dl or platelets \< 100 k/ml
- Is unable or unwilling to provide informed consent
- Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation
Key Trial Info
Start Date :
September 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04011020
Start Date
September 20 2022
End Date
June 20 2025
Last Update
April 29 2024
Active Locations (2)
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1
Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
2
Throne Biotechnologies
Paramus, New Jersey, United States, 07652