NCT01350219

Stem Cell Educator Therapy in Type 1 Diabetes

Phase 2 Study of Stem Cell Educator Therapy in Type 1 Diabetes

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Throne Biotechnologies Inc. · Industry
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The translational potential to the clinical applications of cord blood stem cells has increased enormously in recent years, mainly because of its unique advantages including no risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid availability, and large resource worldwide. Human cord blood contains several types of stem cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess multiple biological properties including the expression of embryonic stem (ES) cell characteristics, giving rise to different types of cells and immune modulation. Specifically, CB-SC can function as an immune modulator that can lead to control of the immune responses, which could in turn be used as a new approach to overcome the autoimmunity of Type 1 diabetes (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Educator therapy in T1D patients.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Stem Cell Educator	For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 8 \~ 9 hrs.

Timeline

• Start date: 2010-09-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2011-05-09
• Last updated: 2019-02-05

Locations

4 sites across 2 countries: China, Spain