- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011748
Clinical Application of Stem Cell Educator Therapy in Alopecia Areata
January 10, 2023 updated by: Throne Biotechnologies Inc.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yong Zhao, MD,PhD
- Phone Number: 2019880290
- Email: Yong.Zhao@ThroneBio.com
Study Contact Backup
- Name: YONG ZHAO, MD,PhD
- Email: Yong.Zhao@ThroneBio.com
Study Locations
-
-
New Jersey
-
Paramus, New Jersey, United States, 07652
- Recruiting
- Throne Biotechnologies
-
Contact:
- Yong Zhao, MD,PhD
- Phone Number: 201-988-0290
- Email: yong.zhao@thronebio.com
-
Principal Investigator:
- Boris Veysman, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 topical minoxidil known to affect AA during a period of 6 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Minoxidil therapy
Control subjects will receive treatment with topical 5% minoxidil
|
AA subjects will be recruited and followed by the treatment with SCE therapy.
|
Experimental: Hair regrowth by SCE
AA subjects will receive Stem Cell Educator therapy.
Hair regrowth will be evaluated during six-month follow-up studies.
|
AA subjects will be recruited and followed by the treatment with SCE therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, and 6 months.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of modulation of autoimmune-related memory T-cell markers
Time Frame: 6 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 month post the SCE therapy.
|
6 months
|
Feasibility of SCE therapy
Time Frame: 6 months
|
The feasibility will be determined by the number of patients who were unable to complete SCE Therapy.
|
6 months
|
Preliminary efficacy of SCE therapy
Time Frame: 6 months
|
This will be determined by the duration of maintaining hair growth following SCE therapy.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2022
Primary Completion (Anticipated)
July 30, 2023
Study Completion (Anticipated)
July 30, 2023
Study Registration Dates
First Submitted
July 4, 2019
First Submitted That Met QC Criteria
July 5, 2019
First Posted (Actual)
July 8, 2019
Study Record Updates
Last Update Posted (Actual)
January 12, 2023
Last Update Submitted That Met QC Criteria
January 10, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-TH-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alopecia Areata
-
Eli Lilly and CompanyRecruitingSkin Diseases | Pathological Conditions, Anatomical | Alopecia | Hypotrichosis | Hair Diseases | Areata AlopeciaUnited States, Taiwan, Japan, Spain, Korea, Republic of, Germany, France, Mexico, Canada, Poland, Australia, Hungary, Argentina
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdActive, not recruitingAlopecia Areata(AA)China
-
University Hospital, RouenCompletedALOPECIA AREATAFrance
-
Services Institute of Medical Sciences, PakistanCompletedExtensive Alopecia AreataPakistan
-
Yale UniversityCompletedAlopecia Areata (AA) | Alopecia Totalis (AT) | Alopecia Universalis (AU)United States
-
Inmagene LLCRecruitingAlopecia Areata (AA)United States, Canada
-
Siriraj HospitalCompletedRecalcitrant Alopecia Totalis | Recalcitrant Alopecia UniversalisThailand
-
EquilliumWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
-
Lindsey BordoneWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
-
Aclaris Therapeutics, Inc.Completed
Clinical Trials on Stem Cell Educator therapy
-
Hackensack Meridian HealthActive, not recruitingDiabetes Mellitus Type 1United States
-
Throne Biotechnologies Inc.Second Xiangya Hospital of Central South UniversityUnknown
-
Throne Biotechnologies Inc.Chinese government fundingsUnknown
-
Throne Biotechnologies Inc.The First Hospital of Hebei Medical UniversityUnknown
-
University of Illinois at ChicagoChinese government; Jinan Tianhe Stem Cell Biotechnologies Co LtdCompleted
-
Throne Biotechnologies Inc.Hackensack Meridian HealthRecruiting
-
Throne Biotechnologies Inc.Chinese PLA General HospitalUnknown
-
Throne Biotechnologies Inc.Not yet recruitingSevere Acute Respiratory Syndrome (SARS) Pneumonia
-
Mongolian National University of Medical SciencesNot yet recruiting
-
Stem Cells ArabiaUnknown