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Clinical Application of Stem Cell Educator Therapy in Alopecia Areata

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ClinicalTrials.gov Identifier: NCT04011748
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborators:
Yale University
Hackensack Meridian Health
Information provided by (Responsible Party):
Tianhe Stem Cell Biotechnologies Inc.

Study Description
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Brief Summary:
Alopecia areata (AA) is a common autoimmune disease that results in loss of body hair in varying degrees. The condition is estimated to affect more than 6.5 million people in the United States alone (naaf.org), with a worldwide prevalence of 0.1% to 0.2% and calculated lifetime risk of 2%. AA is the most common form of the disease, in which areas of complete hair loss arise within normal hair-bearing skin. Other forms include alopecia totalis (AT), characterized by total loss of scalp hair, and alopecia universalis (AU), characterized by complete loss of body hair. AA and its variants can have devastating effects on patients' quality of life and social functioning. At present, curative therapy for AA does not exist. Therapeutic options are currently very limited, such as intralesional injections of glucocorticoids and induction of allergic contact dermatitis. These therapies are not effective for many patients and are generally impractical for patients with diffuse AA, AT or AU. Recently, Janus kinase (JAK) inhibitors were effective for the treatment of severe AA. However, for those patients who do respond, relapses are common after discontinuation of treatment, due to the existing of autoimmune memory T cells. Stem Cell Educator (SCE) therapy, which uses only autologous mononuclear cells that are externally exposed to cord blood stem cells, has previously been proven safe and effective in subjects for the improvement of type 1 diabetes (T1D), T2D and other autoimmune diseases such as alopecia areata. Minoxidil is the FDA approved drug for the treatment of androgenetic alopecia (AGA) in 1988. This trial will explore the therapeutic potential of Stem Cell Educator therapy for the treatment of AA in combined with oral minoxidil.

Condition or disease Intervention/treatment Phase
Alopecia Areata Alopecia Totalis Alopecia Universalis Combination Product: Stem Cell Educator therapy combined with minoxidil Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: AA subjects will receive the treatment with Stem Cell Educator therapy in combined with oral minoxidil.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Treatment of Alopecia Areata With Stem Cell Educator Therapy and Oral Minoxidil
Estimated Study Start Date : February 5, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Haire regrowth by SCE and minoxidil therapy
AA subjects will receive Stem Cell Educator therapy combined with oral minoxidil. Hair regrowth will be evaluated during one-year follow-up studies.
 Combination Product: Stem Cell Educator therapy combined with minoxidil
AA subjects will be recruited and initially primed with oral minoxidil for 30 days, and followed by the treatment with SCE therapy.


Outcome Measures
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Primary Outcome Measures :
  1. The percentage change in scalp hair growth. [ Time Frame: Hair regrowth will be evaluated at different time points post receiving Stem Cell Educator therapy in 1, 3, 6, 9, and 12 months. ]
    The primary endpoint was the percentage change in scalp hair growth, measured with the Severity of Alopecia Tool (SALT) score.


Secondary Outcome Measures :
  1. Feasibility of SCE therapy combined with minoxidil [ Time Frame: 12 months ]
    The feasibility will be determined by the number of patients who were unable to complete SCE Therapy.

  2. Preliminary efficacy of SCE therapy combined with minoxidil [ Time Frame: 12 months ]
    This will be determined by the duration of maintaining hair growth following SCE therapy.

  3. Efficacy of modulation of autoimmune-related memory T-cell markers [ Time Frame: 12 months ]
    Measurements of immune markers' changes will be preformed by flow cytometry such as CD8+CD45RO+CCR7- effector memory T cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12 month post the SCE therapy.

  4. Feasibility of SCE therapy combined with minoxidil [ Time Frame: 12 month ]
    The number of patients who are lost to follow-up prior to the 12-month follow-up visit.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients ( 18 years)
  2. Must have a clinical diagnosis of AA, at least 50% hair loss involving the scalp
  3. For cases in which there is 80% or more scalp hair loss, the duration of the severity of hair loss must be 10 years or less
  4. Stable or worsening hair loss for at least 6 months without evidence of hair regrowth
  5. Patients must not have received any treatments known to affect AA within 2 months of screening
  6. Patients must agree that they are not permitted to use any other treatment besides oral minoxidil known to affect AA during a period of 12 months after undergoing SCE therapy
  7. Adequate venous access for apheresis
  8. Ability to provide informed consent
  9. For female patients only, willingness to use FDA-recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356451.pdf) until 6 months post treatment.
  10. Must agree to comply with all study requirements and be willing to complete all study visits

Exclusion Criteria:

  1. AST or ALT 2 > x upper limit of normal.
  2. Abnormal bilirubin (total bilirubin > 1.2 mg/dL, direct bilirubin > 0.4 mg/dL)
  3. Creatinine > 2.0 mg/dl.
  4. Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
  5. Known active infection such as Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
  6. Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers
  7. Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
  8. Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)
  9. Anticoagulation other than ASA.
  10. Hemoglobin < 10 g/dl or platelets < 100 k/ml
  11. Is unable or unwilling to provide informed consent
  12. Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation
  13. Significant cardiovascular diseases that would make use of oral minoxidil inappropriate.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011748


Contacts
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Contact: Yong Zhao, MD,PhD 2019880290 Zhao@tianhecell.com
Contact: YONG I ZHAO, MD,PhD Zhao@tianhecell.com

Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Contact: Brett King, MD,PhD         
United States, New Jersey
Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
Contact: Mariefel Vendivil       Mariefel.Vendivil@HackensackMeridian.org   
Sponsors and Collaborators
Tianhe Stem Cell Biotechnologies Inc.
Yale University
Hackensack Meridian Health
More Information
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Publications of Results:

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Responsible Party: Tianhe Stem Cell Biotechnologies Inc.
ClinicalTrials.gov Identifier: NCT04011748    
Other Study ID Numbers: 2019-TH-001
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
 Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents