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Clinical Application of Stem Cell Educator Therapy in Alopecia Areata

Primary Purpose

Alopecia Areata, Alopecia Totalis, Alopecia Universalis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stem Cell Educator therapy

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Throne BiotechnologiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Hair regrowth by SCE

Minoxidil therapy

Arm Description

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

Control subjects will receive treatment with topical 5% minoxidil

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Feasibility of SCE therapy

The feasibility will be determined by the number of patients who were unable to complete SCE Therapy.

Preliminary efficacy of SCE therapy

This will be determined by the duration of maintaining hair growth following SCE therapy.

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.

Full Information

NCT ID

NCT04011748

First Posted

July 4, 2019

Last Updated

January 10, 2023

Sponsor

Throne Biotechnologies Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04011748

Brief Title

Clinical Application of Stem Cell Educator Therapy in Alopecia Areata

Official Title

Clinical Treatment of Alopecia Areata With Stem Cell Educator Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 20, 2022 (Actual)

Primary Completion Date

July 30, 2023 (Anticipated)

Study Completion Date

July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Throne Biotechnologies Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Areata, Alopecia Totalis, Alopecia Universalis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

AA subjects will receive the treatment with Stem Cell Educator therapy

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hair regrowth by SCE

Arm Type

Experimental

Arm Description

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

Arm Title

Minoxidil therapy

Arm Type

Experimental

Arm Description

Control subjects will receive treatment with topical 5% minoxidil

Intervention Type

Combination Product

Intervention Name(s)

Stem Cell Educator therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

The percentage change in scalp hair growth.

Description

The primary endpoint was the percentage change in scalp hair growth, measured with the Severity of Alopecia Tool (SALT) score.

Time Frame

Hair regrowth will be evaluated at different time points post receiving Stem Cell Educator therapy in 1, 3, and 6 months.

Secondary Outcome Measure Information:

Title

Feasibility of SCE therapy

Description

The feasibility will be determined by the number of patients who were unable to complete SCE Therapy.

Time Frame

6 months

Title

Preliminary efficacy of SCE therapy

Description

This will be determined by the duration of maintaining hair growth following SCE therapy.

Time Frame

6 months

Title

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

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yong Zhao, MD,PhD

Phone

2019880290

Yong.Zhao@ThroneBio.com

First Name & Middle Initial & Last Name or Official Title & Degree

YONG ZHAO, MD,PhD

Yong.Zhao@ThroneBio.com

Facility Information:

Facility Name

Throne Biotechnologies

City

Paramus

State/Province

New Jersey

ZIP/Postal Code

07652

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yong Zhao, MD,PhD

Phone

201-988-0290

yong.zhao@thronebio.com

First Name & Middle Initial & Last Name & Degree

Boris Veysman, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

35108619

Citation

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.

Results Reference

background

PubMed Identifier

25896390

Citation

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.

Results Reference

result

PubMed Identifier

22233865

Citation

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.

Results Reference

result

PubMed Identifier

22833322

Citation

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.

Results Reference

result

Links:

URL

https://thronebio.com/

Description

Throne Biotechnologies Inc

Learn more about this trial

Clinical Application of Stem Cell Educator Therapy in Alopecia Areata

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