Hackensack Meridian Health
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.
Diabetes Mellitus Type 1
Stem Cell Educator Therapy
Phase 1
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 Type : | Interventional |
Estimated Enrollment : | 9 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes |
Actual Study Start Date : | June 27, 2017 |
Estimated Primary Completion Date : | November 11, 2022 |
Estimated Study Completion Date : | December 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Stem Cell Educator Therapy Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes |
Biological: Stem Cell Educator Therapy |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601