No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Throne Biotechnologies Inc. · Industry
Who this trial is looking for
This trial is looking for people with type 1 diabetes. Participants will have their own immune cells treated with stem cells to help manage their condition better.
Are You a Good Fit for This Trial?
Must not be takingPrednisoneCyclosporineTacrolimusSirolimus
Rules you outHeart diseaseActive infectionOther autoimmune diseases
You may be able to join if
I am over 10 years old.
I have been diagnosed with type 1 diabetes.
I have a blood test showing at least one autoantibody.
My fasting C-peptide level is above 0.3 ng/ml.
I have good veins for blood collection.
I can provide informed consent.
I will use birth control for 6 months if I am female.
I agree to follow all study requirements.
You may not be able to join if
My liver enzymes are too high.
I have abnormal bilirubin levels.
My creatinine level is above 2.0 mg/dl.
I have known heart disease without doctor clearance.
I have an active infection like HIV or hepatitis.
I am pregnant or breastfeeding.
I have taken immunosuppressive medication recently.
I have another autoimmune disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 compr…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Pediatric and adult patients (\>10 years).
2. Must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) Guidelines.
3. Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet beta Cells (IAA, IA2…
Inclusion Criteria:
1. Pediatric and adult patients (\>10 years).
2. Must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) Guidelines.
3. Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet beta Cells (IAA, IA2, GAD 65, ZnT8).
4. Fasting C-peptide level \> 0.3 ng/ml.
5. Adequate venous access for apheresis.
6. Ability to provide informed consent or assent.
7. 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.
8. 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, Human Immunodeficiency Virus (HIV), HTLV (human T-cell leukemia-lymphoma virus cAB), or active tuberculosis.
6. Pregnant or breastfeeding women.
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 (Hashimoto's thyroiditis, celiac disease, lupus, rheumatoid arthritis, scleroderma, etc.).
9. Anticoagulation other than ASA.
10. Hemoglobin \< 10 g/dl or platelets \< 100 k/ml.
11. Subjects with leukopenia, total white blood cells (WBC) count \< 4000/uL.
12. Patient or patient's surrogate is unable or unwilling to voluntarily sign an informed consent form.
13. Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation.
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