Clinical Trial: Stem Cell Educator Therapy in Alopecia Areata

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 1/Phase 2 Study of Stem Cell Educator Therapy in Alopecia Areata

Brief Summary: Alopecia Areata (AA) is one of the most common T cell-mediated autoimmune diseases, leading to the chronic and relapsing hair loss. The prevalence of AA worldwide is 0.1 to 0.2%, affecting an estimated 5.3 million people in the United States. To date, the clinical therapies are limited and disappointed for the treatment of AA. Alternative approaches are needed. Increasing evidence demonstrates that stem cells possess the function of immune modulation. We established the Stem Cell Educator therapy by using cord blood-derived multipotent stem cells (CB-SCs)(Zhao Y, et al. BMC Medicine 2012). 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. Our clinical trial reveals that a single treatment with the Stem Cell Educator provides lasting reversal of autoimmunity that allows regeneration of islet beta cells and improvement of metabolic control in subjects with long-standing type 1 diabetes (T1D), which is another most common T cell-mediated autoimmune disorder in the United States. Here, we develop and explore the therapeutic effectiveness of Stem Cell Educator therapy in AA patients.

Detailed Summary: A 16-gauge IV needle is placed in the left (or right) median cubital vein, and the patient's blood is passed through a Blood Cell Separator MCS+ (Haemonetics®, Braintree, MA) at 35 mL/min for 6 to 7 hours to isolate lymphocytes in accordance with the manufacturer's recommended protocol. The collected lymphocytes are transferred into the device for exposure to allogeneic CB-SCs (or process control without CB-SCs), and other blood components are returned to the patient. After 2 to 3 hours in the device, lymphocytes are returned to the patient's circulation via a dorsal vein in the hand under gravity flow control (2 to 3 mL/min) with physiological saline. Approximately 10,000 mL of blood is processed during the procedure resulting in approximately two repeated educations for the lymphocyte fraction. Patients are hospitalized for two days to monitor temperature and conduct routine laboratory blood tests for adverse reactions following treatment. Follow-up visits are scheduled 4, 12, 24, 40, and 54 weeks after treatment for clinical assessments and laboratory tests
Sponsor: Tianhe Stem Cell Biotechnologies Inc.

Current Primary Outcome: Feasibility and efficacy of Stem Cell Educator therapy in AA [ Time Frame: 1 year ]

The primary study end points are 1) feasibility of the Stem Cell Educator therapy in AA, 2) preliminary evaluation of the efficacy of the therapy for improving hire grow through a year.


Original Primary Outcome: Same as current

Current Secondary Outcome: The efficacy of Stem Cell Educator therapy in modulating autoimmunity [ Time Frame: 1 year ]

The secondary study end point was evidence of the efficacy of the therapy in modulating autoimmunity. Baseline blood samples are collected prior to Stem Cell Educator therapy.


Original Secondary Outcome: Same as current

Information By: Tianhe Stem Cell Biotechnologies Inc.

Dates:
Date Received: August 21, 2012
Date Started: August 2012
Date Completion: July 2013
Last Updated: August 23, 2012
Last Verified: August 2012