NCT02624804

A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Our previous work demonstrated that human cord blood-derived multipotent stem cells (CB-SCs) are a unique type of stem cell identified from human cord blood, distinct from other stem cell types including hematopoietic stem cells (HSCs), and mesenchymal stem cells (MSCs). The stem cells and harnessed some of their unique properties with Stem Cell Educator therapy by using CB-SCs in a closed-loop system that circulates a patient's blood through a blood cell separator, briefly co-cultures the patient's lymphocytes with adherent CB-SCs in vitro, and returns the "educated" lymphocytes (but not the CB-SCs) to the patient's circulation . This treatment leads to global immune modulations and immune balance as demonstrated by clinical data and animal studies. The Stem Cell Educator therapy may revolutionize the clinical treatment of diabetes and other immune-related diseases through CB-SCs' immune education and induction of immune balance, without the safety and ethical concerns associated with conventional stem cell-based approaches

Conditions

• Diabetes Mellitus Type 1

Interventions

Type	Name	Description
BIOLOGICAL	Stem Cell Educator Therapy	Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes

Timeline

• Start date: 2017-06-27
• Primary completion: 2022-11-11
• Completion: 2024-03-11
• First posted: 2015-12-08
• Last updated: 2026-04-03
• Results posted: 2024-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study