It is due to be carried out by researchers from America's prestigious Yale University plus Hackensack Meridian Health, and will also be sponsored by Tianhe Stem Cell Biotechnologies Inc.
At present, oral minoxidil - despite being the pre-cursor to the topical solution - is not authorised for addressing any hairloss condition so this, in addition to the novel stem cell approach, is something of a new approach to Alopecia Areata treatment.
High strength minoxidil is currently MHRA-licensed and FDA-approved for the treatment of Male and Female Pattern Hair Loss only in its topical form, but its use in promoting hair growth for other conditions when administered this way, including Alopecia Areata of the scalp, has been widely acknowledged for many years.
Topical minoxidil's potential for treating hairloss was discovered when patients being treated for conditions such as high blood pressure with oral minoxidil started to experience unusual levels of hair growth as a side effect. It was then developed into its current, dose-dependent topical version.
What this new clinical trial will explore is using oral minoxidil for all types of Alopecia Areata - from Alopecia Areata of the scalp only (which causes sudden bald spots and patchy hair loss), to Alopecia Totalis and Alopecia Universalis, which cause complete baldness of the head and from head-to-toe, respectively. These latter forms are currently the hardest to treat, with the only viable therapies being hospital-based intralesional steroid injections or immunotherapy.
It will also combine the use of oral minoxidil with something called Stem Cell Educator Therapy, which the trial registration information explains is hoping to not only treat all forms of autoimmune alopecia, but also to decrease the number of post-treatment relapses, as has been seen in some JAK inhibitor alopecia treatment trials.
As the authors state, '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 in combined with oral minoxidil.'
The trial registration information states that this Phase 2 study will comprise a total of 20 participants. All will be a minimum of 18 years of age, with a confirmed diagnosis of Alopecia Areata, Totalis or Universalis.
Test subjects will take oral minoxidil for 30 days prior to starting Stem Cell Educator therapy, and their hair growth results will be measured over the course of 12 months.
The estimated completion date for this single group trial, where no placebo group is being used as a control, is 30th April 2021 and updates will be published here on the Belgravia Hair Loss Blog as they become available.
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