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RecruitingPhase 3

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Stem Cell Educator therapy for people older than 10 who have type 1 diabetes. The treatment takes a person's immune cells from their blood, briefly places them with stem cells from cord blood, and returns the immune cells to the person. The goal is to change the immune system's attack on cells that make insulin.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 10 years.
  • Have type 1 diabetes diagnosed using American Diabetes Association guidelines.
  • Have a blood test showing at least one antibody that targets the pancreas's insulin-making cells.
  • Have a fasting C-peptide level above 0.3 ng/mL. This test shows how much insulin your body makes.
  • Have veins suitable for apheresis, a process that removes and returns blood while separating blood cells.
  • Be able to give informed consent or assent, meaning agreement to take part after learning about the study.
  • For female patients, agree to use FDA-recommended birth control until 6 months after treatment.
  • Agree to follow all study rules and complete all study visits.

Who can't join

  • Have high liver blood tests: AST or ALT above twice the normal limit, total bilirubin above 1.2 mg/dL, or direct bilirubin above 0.4 mg/dL; or have creatinine, a kidney blood test, above 2.0 mg/dL.
  • Have known heart artery disease or a heart tracing that suggests it, unless a heart doctor approves apheresis.
  • Have a known active infection, such as hepatitis B or C, HIV, HTLV, or active tuberculosis.
  • Be pregnant or breastfeeding.
  • Have used medicine that weakens the immune system within 1 month before joining, including chemotherapy; or take blood thinners other than aspirin.
  • Have another autoimmune disease, where the immune system attacks the body, such as Hashimoto's thyroid disease, celiac disease, lupus, rheumatoid arthritis, or scleroderma.
  • Have low blood counts: hemoglobin below 10 g/dL, platelets below 100,000/microliter, or white blood cells below 4,000/microliter. These help carry oxygen, stop bleeding, and fight infection.
  • You or your representative cannot or will not freely sign the consent form, or the study doctor believes another physical or mental health condition prevents you from taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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, 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.

Study sites (2)

NJ