Clinical trial NCT01673789: Stem Cell Educator Therapy in Alopecia Areata
Official title: Phase 1/Phase 2 Study of Stem Cell Educator Therapy in Alopecia Areata
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Alopecia Areata
Keywords: Stem Cell Educator
Cord blood stem cells
Immune modulation
Alopecia Areata
Lead sponsor: Throne Biotechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: The First Hospital of Hebei Medical University
First posted: 2012-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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

Eligibility criteria: Inclusion Criteria:

* Patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards recommended by the National Alopecia Areata Foundation (www.naaf.org).

Exclusion Criteria:

* Exclusion criteria are any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria are no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.

Primary outcomes:
measure: Feasibility and efficacy of Stem Cell Educator therapy in AA
timeFrame: 1 year
Secondary outcomes:
measure: The efficacy of Stem Cell Educator therapy in modulating autoimmunity
timeFrame: 1 year
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Throne Biotechnologies Inc.
name: Yong Zhao, MD, PhD
role: STUDY_CHAIR
References:
citation: Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Yin Z, Li H, Zhang Y, Diao Y, Li Y, Chen Y, Sun X, Fisk MB, Skidgel R, Holterman M, Prabhakar B, Mazzone T. Reversal of type 1 diabetes via islet beta cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Med. 2012 Jan 10;10:3. doi: 10.1186/1741-7015-10-3.
citation: Zhao Y. Stem cell educator therapy and induction of immune balance. Curr Diab Rep. 2012 Oct;12(5):517-23. doi: 10.1007/s11892-012-0308-1.
citation: Li Y, Yan B, Wang H, Li H, Li Q, Zhao D, Chen Y, Zhang Y, Li W, Zhang J, Wang S, Shen J, Li Y, Guindi E, Zhao Y. Hair regrowth in alopecia areata patients following Stem Cell Educator therapy. BMC Med. 2015 Apr 20;13:87. doi: 10.1186/s12916-015-0331-6.