Clinical Application of Stem Cell Educator Therapy in Alopecia Areata

NCT04011748 | Unknown Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 2019-TH-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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%. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  6 months

• Preliminary efficacy of SCE therapy

  6 months

• Efficacy of modulation of autoimmune-related memory T-cell markers

  6 months

Study Arms (2)

Hair regrowth by SCE

EXPERIMENTAL

AA subjects will receive Stem Cell Educator therapy. Hair regrowth will be evaluated during six-month follow-up studies.

Combination Product: Stem Cell Educator therapy

Minoxidil therapy

EXPERIMENTAL

Control subjects will receive treatment with topical 5% minoxidil

Combination Product: Stem Cell Educator therapy

Interventions

Stem Cell Educator therapy COMBINATION_PRODUCT

AA subjects will be recruited and followed by the treatment with SCE therapy.

Hair regrowth by SCE; Minoxidil therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Throne Biotechnologies Inc.: lead

Study Sites (1)

Throne Biotechnologies

Paramus, New Jersey, 07652, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 35108619 BACKGROUND

• 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.

  PMID: 25896390 RESULT

• 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.

  PMID: 22233865 RESULT

• 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.

  PMID: 22833322 RESULT

Related Links

• Throne Biotechnologies Inc

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yong Zhao, MD,PhD

CONTACT

2019880290; Yong.Zhao@ThroneBio.com

YONG ZHAO, MD,PhD

CONTACT

Yong.Zhao@ThroneBio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: AA subjects will receive the treatment with Stem Cell Educator therapy

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 8, 2019
• Study Start: September 20, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

US (1)