Alopecia AreataPhase 2NCT04011748
Clinical Application of Stem Cell Educator Therapy in Alopecia Areata
A Phase 2 study testing Stem Cell Educator therapy in people with Alopecia Areata and Alopecia Totalis, run by Throne Biotechnologies Inc. at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- What is being tested?
- Stem Cell Educator therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2022to 30 Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ( 18 years)
- Must have a clinical diagnosis of AA, at least 50% hair loss involving the scalp
- 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
- Stable or worsening hair loss for at least 6 months without evidence of hair regrowth
- Patients must not have received any treatments known to affect AA within 2 months of screening
- 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
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- Adequate venous access for apheresis
- Ability to provide informed consent
- 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.
- Must agree to comply with all study requirements and be willing to complete all study visits
Who cannot join
- AST or ALT 2 > x upper limit of normal.
- Abnormal bilirubin (total bilirubin > 1.2 mg/dL, direct bilirubin > 0.4 mg/dL)
- Creatinine > 2.0 mg/dl.
- Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
- Known active infection such as Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
- Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers
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- Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
- Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)
- Anticoagulation other than ASA.
- Hemoglobin < 10 g/dl or platelets < 100 k/ml
- Is unable or unwilling to provide informed consent
- Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation
- Significant cardiovascular diseases that would make use of oral minoxidil inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Treatment of Alopecia Areata With Stem Cell Educator Therapy
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
- Being tested
- Stem Cell Educator therapy
- Medical subject headings
- Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cell Educator therapyCombination product
AA subjects will be recruited and followed by the treatment with SCE therapy.
| Study group | Role | What they receive |
|---|---|---|
| Hair regrowth by SCE | Experimental | AA subjects will receive Stem Cell Educator therapy. Hair regrowth will be evaluated during six-month follow-up studies. Receives: Combination Product: Stem Cell Educator therapy |
| Minoxidil therapy | Experimental | Control subjects will receive treatment with topical 5% minoxidil Receives: Combination Product: Stem Cell Educator therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hair regrowth will be evaluated at different time points post receiving Stem Cell Educator therapy in 1, 3, and 6 months.
Secondary outcomes (3)
Feasibility of SCE therapy
The feasibility will be determined by the number of patients who were unable to complete SCE Therapy.
Measured: 6 months
Preliminary efficacy of SCE therapy
This will be determined by the duration of maintaining hair growth following SCE therapy.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start20 Sep 2022
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AA subjects will receive the treatment with Stem Cell Educator therapy
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Throne Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Yong Zhao, MD, PhD, Throne Biotechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011748
- Sponsor's protocol ID
- 2019-TH-001
- Status last verified
- Sep 2026
- First submitted
- 4 Jul 2019
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
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.
PubMed 35108619Li 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.
PubMed 25896390Zhao 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.
PubMed 22233865Zhao 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.
PubMed 22833322