NCT04011748

Clinical Application of Stem Cell Educator Therapy in Alopecia Areata

Clinical Treatment of Alopecia Areata With Stem Cell Educator Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Throne Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 6.8 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.

Conditions

• Alopecia Areata
• Alopecia Totalis
• Alopecia Universalis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Stem Cell Educator therapy	AA subjects will be recruited and followed by the treatment with SCE therapy.

Timeline

• Start date: 2022-09-20
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2019-07-08
• Last updated: 2023-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study