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Klinisk tillämpning av stamcellspedagogterapi vid Alopecia Areata

26 september 2026 uppdaterad av: Yong Zhao, MD, PhD, Throne Biotechnologies Inc.

Klinisk behandling av alopecia areata med stamcellspedagogterapi och Minoxidil

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

20

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New Jersey
      • Paramus, New Jersey, Förenta staterna, 07652
        • Throne Biotechnologies

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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 topical minoxidil known to affect AA during a period of 6 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Hair regrowth by SCE

AA subjects will receive Stem Cell Educator therapy. Hair regrowth will be evaluated during six-month follow-up studies.
Kombinationsprodukt: Stem Cell Educator therapy

AA subjects will be recruited and followed by the treatment with SCE therapy.
Experimentell: Minoxidil therapy

Control subjects will receive treatment with topical 5% minoxidil
Kombinationsprodukt: Stem Cell Educator therapy

AA subjects will be recruited and followed by the treatment with SCE therapy.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The percentage change in scalp hair growth.
Tidsram: Hair regrowth will be evaluated at different time points post receiving Stem Cell Educator therapy in 1, 3, and 6 months.

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility of SCE therapy
Tidsram: 6 months

The feasibility will be determined by the number of patients who were unable to complete SCE Therapy.
6 months
Preliminary efficacy of SCE therapy
Tidsram: 6 months

This will be determined by the duration of maintaining hair growth following SCE therapy.
6 months
Efficacy of modulation of autoimmune-related memory T-cell markers
Tidsram: 6 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 month post the SCE therapy.
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Throne Biotechnologies Inc.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 september 2022

Primärt slutförande (Beräknad)

30 juli 2027

Avslutad studie (Beräknad)

30 juli 2027

Studieregistreringsdatum

Först inskickad

4 juli 2019

Först inskickad som uppfyllde QC-kriterierna

5 juli 2019

Första postat (Faktisk)

8 juli 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2019-TH-001

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

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