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

Diabetes Mellitus Type 1 Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02624804
Study type Interventional
Source Hackensack Meridian Health
Contact
Status Active, not recruiting
Phase Phase 1
Start date June 27, 2017
Completion date December 2023
View Details
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