NCT02624804CompletedPhase 1
A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
This is a prospective, single arm, open-label, single-center pilot study to assess the safety, feasibility, and efficacy of Stem Cell Educator therapy for the treatment of patients with Type 1 Diabetes.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 4 Dec 2015
- Start date
- Jun 2017
- Primary completion date
- Nov 2022
- Lead sponsor
- Hackensack Meridian Health
- Diseases
- Type 1 diabetes
- NCT number
- NCT02624804
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 13
- From Jun 2017 to the primary completion date, Nov 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
Other illness
- Known active infection
- Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)
- Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation
Lab values
- AST or ALT 2 \> x upper limit of normal.
- 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.
- Hemoglobin \< 10 g/dl or platelets \< 100 k/ml
Other
- Pregnancy or breastfeeding mothers
- Anticoagulation other than ASA.
- Is unable or unwilling to provide informed consent
Who the study is looking for
- Adult patients \>/=18 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
- Adequate venous access for apheresis
- Ability to provide informed consent
- Must agree to comply with all study requirements and be willing to complete all study visits
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hackensack University Medical Center - John Theurer Cancer Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.