A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
NCT02624804 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2026-04-03
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.
Conditions
- Diabetes Mellitus Type 1
Interventions
- BIOLOGICAL
-
Stem Cell Educator Therapy
Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
Sponsors & Collaborators
-
Hackensack Meridian Health
lead OTHER
Principal Investigators
-
Michelle Donato, MD · Hackensack Meridian Health
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-27
- Primary Completion
- 2022-11-11
- Completion
- 2024-03-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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