Stem Cell Educator Therapy in Alopecia Areata

Learn more about:
Related Clinical Trial
A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata Modified SALT Score for Alopecia Areata Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss – Alopecia Areata TREg Activation in the Treatment of the PELADE (Alopecia Areata) The Effectiveness of Mindfulness Based Cognitive Group Therapy for Social Anxiety Symptoms in People Living With Alopecia Areata Response of Topical Capsaicin in Alopecia Areata Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata. Jaktinib Dihydrochloride Monohydrate in Severe Alopecia Areata Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade Stem Cell Educator Therapy in Alopecia Areata Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata Vytorin in the Treatment of Alopecia Areata Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata The Efficacy and Safety of Different Concentrations of Localized Injections of Steroids in the Treatment of Alopecia Areata Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata A Trial of Clobetasol Propionate Versus Hydrocortisone in Children With Alopecia Areata Efficacy and Safety of LH-8 in Paediatric Alopecia Areata Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata Intralesional Steroids in the Treatment of Alopecia Areata A Phase II Study in Patients With Alopecia Areata Topical Crisaborole in Patients With Alopecia Areata Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata Efficacy of Fractional CO2 Laser as a Mono- or Adjuvant Therapy for Alopecia Areata Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Treatment With Aldara 5% Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females Excimer Light for Alopecia Areata Biocellular-Cellular Regenerative Treatment Scaring Alopecia and Alopecia Areata Safety and Efficacy Study of SHAPE Gel in Alopecia Areata Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata Topical Garlic Concentrate for Alopecia Areata in Children Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata Aldara for the Treatment of Extensive Alopecia Areata A Clinical Trial to Evaluate the Efficacy of Abatacept in Moderate to Severe Alopecia Areata Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata LEO 124249 Ointment in the Treatment of Alopecia Areata Childhood Alopecia Areata Study Using the 308-nm Excimer Laser Alefacept in Patients With Severe Scalp Alopecia Areata Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata

Brief Title

Stem Cell Educator Therapy in Alopecia Areata

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 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
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Feasibility and efficacy of Stem Cell Educator therapy in AA

Secondary Outcome

 The efficacy of Stem Cell Educator therapy in modulating autoimmunity

Condition

Alopecia Areata

Intervention

Stem Cell Educator

Study Arms / Comparison Groups

 Stem Cell Educator
Description:  The collected lymphocytes are transferred into the device for exposure to CB-SCs, and other blood components are automatically returned to the patient. The Stem Cell Educator functions as part of a closed-loop system that circulates a patient's blood through a blood cell separator, briefly co-cultures the patient's lymphocytes with CB-SCs in vitro, and returns the educated lymphocytes to the patient's circulation. CB-SCs tightly attached to interior surfaces in the device, and only the CB-SC-educated autologous lymphocytes are returned to the subjects. The Stem Cell Educator therapy requires only two venipunctures with minimal pain, and does not introduce stem cells or reagents into patients.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

30

Start Date

August 2012

Completion Date

July 2013

Primary Completion Date

July 2013

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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Yong Zhao, MD, PhD, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01673789

Organization ID

2012-TH01


Responsible Party

Sponsor

Study Sponsor

Tianhe Stem Cell Biotechnologies Inc.

Collaborators

 The First Hospital of Hebei Medical University

Study Sponsor

Yong Zhao, MD, PhD, Study Chair, Tianhe Stem Cell Biotechnologies Inc.


Verification Date

August 2012