Clinical Application of Stem Cell Educator Therapy in Alopecia Areata
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04011748|
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : December 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||AA subjects will receive the treatment with Stem Cell Educator therapy in combined with oral minoxidil.|
|Masking:||None (Open Label)|
|Official Title:||Clinical Treatment of Alopecia Areata With Stem Cell Educator Therapy and Oral Minoxidil|
|Estimated Study Start Date :||February 5, 2020|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: Haire regrowth by SCE and minoxidil therapy
AA subjects will receive Stem Cell Educator therapy combined with oral minoxidil. Hair regrowth will be evaluated during one-year follow-up studies.
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.
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||Zhao@tianhecell.com|
|Contact: YONG I ZHAO, MD,PhD||Zhao@tianhecell.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: Mariefel Vendivil Mariefel.Vendivil@HackensackMeridian.org|