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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hair regrowth by SCE | Experimental | AA subjects will receive Stem Cell Educator therapy. Hair regrowth will be evaluated during six-month follow-up studies. |
|
| Minoxidil therapy | Experimental | Control subjects will receive treatment with topical 5% minoxidil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell Educator therapy | Combination Product | AA subjects will be recruited and followed by the treatment with SCE therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change in scalp hair growth. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of SCE therapy | The feasibility will be determined by the number of patients who were unable to complete SCE Therapy. | 6 months |
| Preliminary efficacy of SCE therapy | This will be determined by the duration of maintaining hair growth following SCE therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Zhao, MD,PhD | Contact | 2019880290 | Yong.Zhao@ThroneBio.com | |
| YONG ZHAO, MD,PhD | Contact | Yong.Zhao@ThroneBio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Throne Biotechnologies | Recruiting | Paramus | New Jersey | 07652 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35108619 | Background | Zhao Y, Knight CM, Jiang Z, Delgado E, Van Hoven AM, Ghanny S, Zhou Z, Zhou H, Yu H, Hu W, Li H, Li X, Perez-Basterrechea M, Zhao L, Zhao Y, Giangola J, Weinberg R, Mazzone T. Stem Cell Educator therapy in type 1 diabetes: From the bench to clinical trials. Autoimmun Rev. 2022 May;21(5):103058. doi: 10.1016/j.autrev.2022.103058. Epub 2022 Jan 31. | |
| 25896390 |
| Label | URL |
|---|---|
| Throne Biotechnologies Inc | View source |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| C537055 | Alopecia universalis |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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AA subjects will receive the treatment with Stem Cell Educator therapy
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| 6 months |
| Efficacy of modulation of autoimmune-related memory T-cell markers | 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 |
| Li Y, Yan B, Wang H, Li H, Li Q, Zhao D, Chen Y, Zhang Y, Li W, Zhang J, Wang S, Shen J, Li Y, Guindi E, Zhao Y. Hair regrowth in alopecia areata patients following Stem Cell Educator therapy. BMC Med. 2015 Apr 20;13:87. doi: 10.1186/s12916-015-0331-6. |
| 22233865 | Result | Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Yin Z, Li H, Zhang Y, Diao Y, Li Y, Chen Y, Sun X, Fisk MB, Skidgel R, Holterman M, Prabhakar B, Mazzone T. Reversal of type 1 diabetes via islet beta cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Med. 2012 Jan 10;10:3. doi: 10.1186/1741-7015-10-3. |
| 22833322 | Result | Zhao Y. Stem cell educator therapy and induction of immune balance. Curr Diab Rep. 2012 Oct;12(5):517-23. doi: 10.1007/s11892-012-0308-1. |
| D017437 |
| Skin and Connective Tissue Diseases |