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Clinical Application of Stem Cell Educator Therapy in Alopecia Areata

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Jul 30, 2023 to Jul 30, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  2. Primary completion date: Dec 30, 2022 to Jul 30, 2023v6 Show 4 more changesShow less
    • Study completion date: Jun 30, 2023 to Jul 30, 2023
    • Interventions: Stem Cell Educator therapy combined with minoxidil (Combination Product) to Stem Cell Educator therapy (Combination Product)
    • Eligibility criteria revised
    • Secondary endpoints: 4 to 3
  3. Study sites: 2 to 1
    • Collaborators shortened, about 5 words
    v5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 7 more changesShow less
    • Primary completion date: Apr 30, 2022 to Dec 30, 2022
    • Start date changed from estimate of Oct 30, 2021 to Sep 20, 2022
    • Study completion date: Jun 30, 2022 to Jun 30, 2023
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study sites revised (2)
    • Publications: 3 to 4
  5. Primary completion date: Oct 31, 2020 to Apr 30, 2022v3 Show 4 more changesShow less
    • Start date: Feb 5, 2020 to Oct 30, 2021
    • Study completion date: Apr 30, 2021 to Jun 30, 2022
    • Site contacts updated at 1 of 2 sites
    • Study arms: 1 to 2
  6. Start date: Nov 1, 2019 to Feb 5, 2020v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04011748
Lead Sponsor Throne Biotechnologies Inc.
Conditions
(from sponsor)		 Alopecia Areata, Alopecia Totalis, Alopecia Universalis
Related terms Alopecia Areata, Alopecia universalis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov