Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 20, 2022

Primary Completion Date

October 20, 2024

Study Completion Date

June 20, 2025

Conditions
Type 1 Diabetes
Interventions
COMBINATION_PRODUCT

Stem Cell Educator therapy

Patients with T1D will be evaluated by the study principal investigator or co-investigators. Informed consent will be obtained at the initial screening visit. The initial screening visit will occur within 30 days of initiation of SCE therapy. The second screening visit will occur within 7 days of therapy. Subjects who meet all criteria will be scheduled for treatment. All enrolled subjects will receive treatment with the SCE system consisting of a single session of mononuclear cells (MNC) collection by apheresis where 10 L of blood will be processed on day -1. The MNC product will then be exposed over to the SCE and on day 0 the product will be infused intravenously back to the patient.

Trial Locations (2)

07601

ACTIVE_NOT_RECRUITING

Hackensack Meridian Health, Hackensack

07652

RECRUITING

Throne Biotechnologies, Paramus

All Listed Sponsors
collaborator

Hackensack Meridian Health

OTHER

lead

Throne Biotechnologies Inc.

INDUSTRY