RECRUITING

Clinical Application of Stem Cell Educator Therapy in Alopecia Areata

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Conditions

Alopecia AreataAlopecia TotalisAlopecia Universalis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 6.8 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 by using topical minoxidil as control.

Official Title

Clinical Treatment of Alopecia Areata With Stem Cell Educator Therapy

Quick Facts

Study Start:2022-09-20
Study Completion:2023-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04011748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult patients ( 18 years)
  2. 2. Must have a clinical diagnosis of AA, at least 50% hair loss involving the scalp
  3. 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. 4. Stable or worsening hair loss for at least 6 months without evidence of hair regrowth
  5. 5. Patients must not have received any treatments known to affect AA within 2 months of screening
  6. 6. Patients must agree that they are not permitted to use any other treatment besides topical minoxidil known to affect AA during a period of 6 months after undergoing SCE therapy
  7. 7. Adequate venous access for apheresis
  8. 8. Ability to provide informed consent
  9. 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. 10. Must agree to comply with all study requirements and be willing to complete all study visits
  1. 1. AST or ALT 2 \> x upper limit of normal.
  2. 2. Abnormal bilirubin (total bilirubin \> 1.2 mg/dL, direct bilirubin \> 0.4 mg/dL)
  3. 3. Creatinine \> 2.0 mg/dl.
  4. 4. Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
  5. 5. Known active infection such as Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
  6. 6. Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers
  7. 7. Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
  8. 8. Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)
  9. 9. Anticoagulation other than ASA.
  10. 10. Hemoglobin \< 10 g/dl or platelets \< 100 k/ml
  11. 11. Is unable or unwilling to provide informed consent
  12. 12. Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation
  13. 13. Significant cardiovascular diseases that would make use of oral minoxidil inappropriate.

Contacts and Locations

Study Contact

Yong Zhao, MD,PhD
CONTACT
2019880290
Yong.Zhao@ThroneBio.com
YONG ZHAO, MD,PhD
CONTACT
Yong.Zhao@ThroneBio.com

Study Locations (Sites)

Throne Biotechnologies
Paramus, New Jersey, 07652
United States

Collaborators and Investigators

Sponsor: Throne Biotechnologies Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-20
Study Completion Date2023-07-30

Study Record Updates

Study Start Date2022-09-20
Study Completion Date2023-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Alopecia Areata
  • Alopecia Totalis
  • Alopecia Universalis