Phase 1
Completed N=13
A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
Diabetes Mellitus Type 1
Source: ClinicalTrials.gov NCT02624804 ↗
Enrolled (actual)
13
Serious AEs
12.5%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Treatment Related Adverse Events — 1 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Related Adverse Events |
1 | — |
| SECONDARY Number of Patients Unable to Complete Therapy |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
- Known active infection
- Pregnancy 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
Data sourced from ClinicalTrials.gov (NCT02624804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.