Clinical Application of Stem Cell Educator Therapy in Alopecia Areata
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ClinicalTrials.gov Identifier: NCT04011748 |
Recruitment Status :
Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : June 30, 2021
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Condition or disease | Intervention/treatment | Phase |
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Alopecia Areata Alopecia Totalis Alopecia Universalis | Combination Product: Stem Cell Educator therapy combined with minoxidil | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | AA subjects will receive the treatment with Stem Cell Educator therapy in combined with oral minoxidil. |
Masking: | Double (Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Clinical Treatment of Alopecia Areata With Stem Cell Educator Therapy and Oral Minoxidil |
Estimated Study Start Date : | October 30, 2021 |
Estimated Primary Completion Date : | April 30, 2022 |
Estimated Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Haire regrowth by SCE
AA subjects will receive Stem Cell Educator therapy combined with oral minoxidil. Hair regrowth will be evaluated during one-year follow-up studies.
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Combination Product: Stem Cell Educator therapy combined with minoxidil
AA subjects will be recruited and initially primed with oral minoxidil for 30 days, and followed by the treatment with SCE therapy. |
Experimental: Minoxidil therapy
Control subjects will receive treatment with topical 5% minoxidil
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Combination Product: Stem Cell Educator therapy combined with minoxidil
AA subjects will be recruited and initially primed with oral minoxidil for 30 days, and followed by the treatment with SCE therapy. |
- The percentage change in scalp hair growth. [ Time Frame: Hair regrowth will be evaluated at different time points post receiving Stem Cell Educator therapy in 1, 3, 6, 9, and 12 months. ]The primary endpoint was the percentage change in scalp hair growth, measured with the Severity of Alopecia Tool (SALT) score.
- Feasibility of SCE therapy combined with minoxidil [ Time Frame: 12 months ]The feasibility will be determined by the number of patients who were unable to complete SCE Therapy.
- Preliminary efficacy of SCE therapy combined with minoxidil [ Time Frame: 12 months ]This will be determined by the duration of maintaining hair growth following SCE therapy.
- Efficacy of modulation of autoimmune-related memory T-cell markers [ Time Frame: 12 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, 9, 12 month post the SCE therapy.
- Feasibility of SCE therapy combined with minoxidil [ Time Frame: 12 month ]The number of patients who are lost to follow-up prior to the 12-month follow-up visit.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 oral minoxidil known to affect AA during a period of 12 months after undergoing SCE therapy
- 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
Exclusion Criteria:
- 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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011748
Contact: Yong Zhao, MD,PhD | 2019880290 | Yong.Zhao@ThroneBio.com | |
Contact: YONG ZHAO, MD,PhD | Yong.Zhao@ThroneBio.com |
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520 | |
Contact: Brett King, MD,PhD | |
United States, New Jersey | |
Hackensack Meridian Health | |
Hackensack, New Jersey, United States, 07601 | |
Contact: Paul Wang, MD |
Publications of Results:
Responsible Party: | Throne Biotechnologies Inc. |
ClinicalTrials.gov Identifier: | NCT04011748 |
Other Study ID Numbers: |
2019-TH-001 |
First Posted: | July 8, 2019 Key Record Dates |
Last Update Posted: | June 30, 2021 |
Last Verified: | June 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases |
Pathological Conditions, Anatomical Minoxidil Antihypertensive Agents Vasodilator Agents |